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Summary of adverse events (AEs) by safety analysis set. | diarrhoea, myalgia, fatigue, headache, arthralgia | ADVERSE EVENT | AE, adverse event.For AEs at the indicated severity with two numbers, n represents the number of participants per category/number of AEs as one participant experienced several cases of the same AE during the study.The most commonly reported reactions in the Ad5-nCoV group included increase in body temperature (20.2%), headache (5.9%), fatigue (5.4%), myalgia (4.8%) and arthralgia (1.9%; In the Placebo group, reactions included increase in body temperature (6.5%), headache (4.8%), fatigue (4.8%) and diarrhoea (0.8%). These AEs were mild or moderate; no severe reactions were reported (Tables There were no fatal outcomes. During the first 7 days after vaccination, a total of six serious AEs (SAEs) were reported ( | PMC9994755 |
Injection site reactions | swelling, pain | INDURATION, INJECTION SITE REACTION, INJECTION SITE REACTIONS | Injection site reactions occurred in 106 participants (28.5%) who received the Ad5-nCoV vaccine. By comparison, only 2 participants in the Placebo group (1.6%) experienced an injection site reaction including swelling and pain or induration ( | PMC9994755 |
Other adverse events (excluding immunisation reactions) | SAEs | EVENTS, INJECTION SITE REACTION | As listed in For most participants, AEs were mild, reported in 28.5% of the Ad5-nCoV group and 16.1% of the Placebo group. Moderate events were registered in 5.6% of participants who received the Ad5-nCoV vaccine and 4.0% who received the placebo. By comparison, SAEs occurred in 0.8% of participants in the Ad5-nCoV group, but none in the Placebo group; these included increases in C-reactive protein (0.5%) and blood fibrinogen levels (0.5%).For most participants, general and injection site reactions and AEs resolved within 7 days after vaccination.Results of the analysis of laboratory parameters demonstrated a trend towards an increase in C-reactive protein levels, an increase in the red cell sedimentation rate, an increase in the mean percentage of monocytes, and a decrease in the mean percentage of neutrophils after administration of Ad5-nCoV (The proportion of participants in the Ad5-nCoV group with elevated IgE at Day 28 showed no changes from screening: 73/372 (19.6%) to 76/365 (20.8%). | PMC9994755 |
Discussion | RBD, headache, pain | ADVERSE REACTIONS, SECONDARY, ADENOVIRUS | In this multicentre, randomised, double-blind, placebo-controlled, phase 3 trial including 500 adult participants aged 18–85 years (mean age: 41.2 years), the immunogenicity, efficacy and safety of the Ad5-nCoV COVID-19 vaccine was assessed up to 6 months after vaccination. Both study groups (Ad5-nCoV and Placebo) had similar baseline characteristics. A single immunisation with the Ad5-nCoV vaccine led to a marked immune response. The primary endpoint (seroconversion rate of anti-RBD antibodies on Day 28 after vaccination) and all secondary endpoints on Day 28 after vaccination showed a strong immunogenic response to the Ad5-nCoV vaccine.The Ad5-nCoV vaccine has a good safety profile comparable with the findings of preceding clinical trials in healthy adults. Most post-vaccination AEs were mild or moderate in severity. Although the proportions of participants who reported adverse reactions such as an increase in body temperature, headache, and pain at the injection site were higher in those that received the Ad5-nCoV vaccine, adverse reactions within 28 days were generally mild to moderate and the majority resolved within 7 days after vaccination. All Grade 3 AEs occurred among participants from the Ad5-nCoV group and were similar to commonly reported AEs after other types of immunisation.For those vaccinated with Ad5-nCoV, the seroconversion rate of antibodies against RBD (78.5%) and of NAbs (59.0%) on Day 28 (Interestingly, GMTs of anti-RBD, S protein-specific antibodies and neutralizing SARS-CoV-2 antibodies were elevated at Month 6 post-vaccination in the Placebo group, not by Day 14 or Day 28 (Even disregarding other COVID-19 candidate vaccines that use a recombinant Ad5 vector, adenovirus exposure itself is common. Pre-existing anti-Ad5 immunity may affect the immunogenicity of Ad5-based vaccines, and as a result, their efficacy against COVID-19. However, the proportion of individuals with high anti-Ad5 titres can vary across geographical regions [In this study, we also uncovered the response of pre-existing immunity to Ad5 and showed how it affects subsequent humoral immune responses as well as the longevity of immunity to COVID-19. In participants vaccinated with Ad5-nCoV, there was no difference in humoral immunity to SARS-CoV-2 between those with pre-existing anti-Ad5 titres at baseline above or below the cut-off of 1:200. However using a cut-off of 1:5, we showed that those with pre-existing low Ad5 titres (1:5; Our study provides data on the incidence of anti-Ad5 immunity in the Russian population, admittedly in a relatively small, sample size. Almost all participants had pre-existing neutralising antibodies to Ad5, although levels were generally very low. No such data were available before this study, and only limited and highly variable data are available for the level of Ad5 immunity in Europe.There are currently multiple recombinant Ad-vectored COVID-19 candidate vaccines registered or in development [Other study limitations included the fact all participants were white, although conversely, this also provided the first data in a non-Chinese, European population. Nor did this trial include children or pregnant women, and there were only a small number of older adults (35 were ≥60 years in the Ad5-nCoV group). An ideal candidate vaccine for COVID-19 should cover vulnerable populations of all ages. Anti-S protein-specific antibodies have been reported to decline rapidly in individuals who have recovered from COVID-19, especially those who were asymptomatic or had mild symptoms [ | PMC9994755 |
Conclusions | infections | VIRUS, INFECTIONS | Analysis of data from this phase 3 trial demonstrated the immunogenicity and safety of this Ad5-vector based COVID-19 vaccine. More data are required to determine whether this vaccine reduces infections and transmission. Overall, this stable, single-dose vaccine could contribute to the global fight against the evolving SARS-CoV-2 virus. | PMC9994755 |
Supporting information | PMC9994755 |
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CONSORT checklist. | (DOC)Click here for additional data file. | PMC9994755 |
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Study protocol. | (DOCX)Click here for additional data file. | PMC9994755 |
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Additional details of statistical analysis. | (DOCX)Click here for additional data file. | PMC9994755 |
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Summary of geometric mean titres and seroconversion rates post-vaccination with Ad5-nCoV or placebo (full analysis set). | (DOCX)Click here for additional data file. | PMC9994755 |
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Systemic (general) post-vaccination reactions (safety analysis set). | (DOCX)Click here for additional data file. | PMC9994755 |
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Systemic (general) post-vaccination reactions by severity (safety analysis set). | (DOCX)Click here for additional data file. | PMC9994755 |
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Summary of all severe adverse events that led to hospitalisation or prolonged hospitalisation (safety analysis set). | (DOCX)Click here for additional data file. | PMC9994755 |
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Local post-vaccination reactions (safety analysis set). | (DOCX)Click here for additional data file. | PMC9994755 |
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Local post-vaccination reactions by severity (safety analysis set). | (DOCX)Click here for additional data file. | PMC9994755 |
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Other adverse events unrelated to vaccination reactions (safety analysis set). | (DOCX)Click here for additional data file. | PMC9994755 |
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Background | neck pain | The advancement of technology has contributed to a more sedentary lifestyle, and the extensive use of handheld devices among adolescents may potentially result in neck pain. This study aimed to assess the association between exposure to common technology devices and self-reported neck pain in Iranian school-age adolescents. | PMC10644474 |
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Methods | pain | This cross-sectional study was conducted between June and October 2021, employing a randomized multi-stage cluster sampling approach. We enrolled 808 adolescent students aged 11 to 19 years old. We asked participants about any neck pain they experienced in the week leading up to the study. Additionally, we gathered demographic information and assessed participants’ use of electronic devices using a questionnaire. | PMC10644474 |
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Results | neck pain | REGRESSION | Our study comprised 73.5% female participants with an average age of 15.1 ± 1.7 years and 26.5% male participants with an average age of 14.5 ± 1.5 years. In the regression model, the female gender (p = 0.038), using mobile for more than 6 h (p = 0.04), and using electronic devices while sitting on the floor (p = 0.02) were associated with a higher prevalence of neck pain among participants. | PMC10644474 |
Conclusion | neck pain | In our study, we observed a relatively high prevalence of neck pain, which was linked to extended daily mobile phone usage and body posture during electronic device use. Policymakers may consider interventions aimed at reducing mobile phone usage and promoting proper body posture while using electronic devices as potential strategies to alleviate the burden of neck pain among Iranian adolescents. | PMC10644474 |
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Keywords | PMC10644474 |
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Background | neck pain, Musculoskeletal pain | Musculoskeletal pain (MSKP) is a global health concern that affects individuals of all ages and genders, presenting with diverse manifestations [Information and Communication Technology (ICT) comprises a wide range of devices, including mobile phones, tablets, gaming consoles, televisions, computers, and laptops. [Studies on the association between ICT use and MSKPs, especially neck pain among adolescents, are limited, and there are controversies regarding this association [ | PMC10644474 |
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Method and materials | PMC10644474 |
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Design | This cross-sectional study was conducted from June to October 2021. The ethics committee of Tehran University of Medical Sciences approved the study (ethics code: IR.TUMS.IKHC.REC.1400.320). The ethics committee waived the parental consent for this study as this was an observational study with no intervention. | PMC10644474 |
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Participants & setting | We calculated the sample size using G*Power 3.1.9.7. Employing the Exact test family and a binomial statistical test, with a small effect size of 0.05, α = 0.05, and power = 0.8, we determined a sample size of 786 participants. To accommodate an anticipated dropout rate of 5%, we enrolled 808 individuals in our study [In this study, we utilized a randomized multi-stage cluster sampling method. Initially, we randomly selected two city districts out of a total of three in Qazvin. Next, two schools were randomly chosen from each of these city districts, and a total of 202 students were randomly selected from each chosen school. To do this, we acquired the class lists and selected the first class from every three available. One of our researchers then attended the selected classes and gathered participants’ data through questionnaires. We explained the study’s objectives to the participants, and they provided informed consent before participating in the study. | PMC10644474 |
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Measurements | Our questionnaire evaluated three groups of variables, including basic and demographic variables, exposures, and outcomes.The demographic variables included age (years), gender (male or female), educational level (level one high school or level two high school), body mass index (BMI), and family structure (living with both parents, father, mother, or other relatives). Level one high school equals 7 to 9 years of education, and level two high school equals 10 to 12 years of education in Iran. The exposures (independent variable) included types of ICTs (e.g., mobile phone, tablet, PlayStation 4, laptop, and computer), position using electronic devices (sitting at the table, sitting on the floor, and lying), and the average amount of time they spent with each ICT per day in the past week (1. I do not use, 2. less than 3 h per day, 3. between 3 and 6 h per day, 4. more than 6 h per day). The outcome was any episodes of neck pain in the past week, as reported by the participants. | PMC10644474 |
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Statistical analysis | neck pain | REGRESSION | Mean and standard deviation (SD) were calculated for continuous variables. Number and percentage were calculated for categorical variables. We used the Fisher exact or Chi-square tests to compare the categorical variables across groups. We used a binary logistic regression model to determine the factors independently associated with neck pain and calculated the adjusted odds ratios (AOR). We adjusted the model for BMI and gender as possible confounding factors. Missing values were excluded from the relevant analyses. P < 0.05 was considered statistically significant. We used IBM SPSS version 22 for all the analyses. | PMC10644474 |
Results | neck pain | REGRESSION | Eight hundred-eight adolescents aged 11 to 19 were included in our study. Our sample included 73.5% female participants, with a mean age of 15.1 ± 1.7 years, and 26.5% male participants, with an average age of 14.5 ± 1.5 years. Among all participants, 95.2% lived with both parents, while 3.3% lived with their mother, 0.6% with their father, and 0.9% with other relatives. The prevalence of neck pain was 21.5% in our study, with 174 participants reporting neck pain in the week before the study. The prevalence of neck pain was significantly higher among females than males (23.7% vs. 15.4%, p = 0.012), and it was also more common among students in level two high school compared to those in level one high school (25.2% vs. 17.4%, p = 0.01) (Table
Relationship between neck pain and demographic characteristics of participants214(26.5)33(15.4)181(84.6)594(73.5)141(23.7)453(76.3)Underweight(BMI < 18.5)215(28.3)43(20)172(80)Normal(18.5–24.9)443(58.4)98(22.2)345(77.8)Overweight(25.0-29.9)82(10.8)20(24.4)62(75.63)Obese(> 30)19(2.5)6(31.6)13(68.4)442(59.4)77(17.4)365(82.6)302(40.6)76(25.2)226(74.8)Values are reported as numbers (percentages)Mobile phones (96.9%), laptops (30.5%), and computers (23.4%) were the most frequently used devices among the participants. Duration of mobile phone use (p = 0.018), duration of PlayStation 4 use (p = 0.012), and position using electronic devices (p = 0.014) were associated with the prevalence of neck pain among the participants (Table
Association between neck pain and use of electronic devices among the participants24(3.1)1(4.2)23(95.8)321(41.8)57(17.8)264(82.2)276(36)59(21.4)217(78.6)147(19.1)42(28.6)105(71.4)663(89.1)140(21.1)523(78.9)59(7.9)11(18.6)48(81.4)17(2.3)2(11.8)15(88.2)5(0.7)5(100)570(76.6)118(20.7)452(79.3)146(19.6)27(18.5)119(81.5)21(2.8)6(28.6)15(71.4)7(1)2(28.6)5(71.4)517(69.5)105(23.3)412(79.7)180(24.2)37(20.6)143(79.4)33(4.4)7(21.2)26(78.8)14(1.9)4(28.6)10(71.4)631(84.8)134(21.2)497(78.8)101(13.6)26(25.7)75(74.3)8(1.1)5(62.5)3(37.5)4(0.5)3(75)1(25)324(40.1)61(18.8)263(81.2)324(40.1)65(20.1)259(79.9)160(19.8)48(30)112(70)Values are reported as numbers (percentage)In the regression model, the female gender (AOR = 1.62, p = 0.038), using mobile for more than 6 h (AOR = 1.62, p = 0.04), and using electronic devices while sitting on the floor (AOR = 1.75, p = 0.02) were associated with a higher prevalence of neck pain among participants (Table
Results of binary logistic regression model on the association between exposures and confounders and neck pain among participants | PMC10644474 |
Discussion | neck pain, fatigue, pain | REGRESSION, MUSCULOSKELETAL DISORDERS | MSKPs often lack definitive treatments and may require prolonged therapeutic interventions, resulting in significant adverse consequences affecting healthcare demands, daily functional abilities, and adolescent social engagement [Among the devices we examined in our study, mobile phones emerged as the most commonly used. This finding is crucial as we discovered a significant association between using mobile phones for more than 6 h and a higher likelihood of experiencing neck pain among adolescents. In the study conducted by Mongkonkansai et al., the duration of smartphone use was a predictor for musculoskeletal discomfort among students. When comparing students who used cell phones for less than 60 min per day to those who exceeded this threshold, the latter group exhibited a tenfold higher likelihood of developing musculoskeletal disorders [We found that the body position while using electronic devices is associated with the likelihood of experiencing neck pain among adolescents. While the prevalence of neck pain was higher among those using devices while lying down, our regression model revealed that using electronic devices while sitting on the floor was associated with an increased likelihood of neck pain. This finding aligns with prior studies, which have indicated that prolonged use of electronic devices with improper posture throughout the day can elevate the risk of experiencing discomfort, pain, and fatigue [In our study, 21.5% of participants reported experiencing neck pain in the week leading up to the study. The prevalence of neck pain among children and adolescents varies considerably across studies, ranging from 12.3–32% [We found that female gender is associated with higher odds of neck pain in adolescents, which aligns with previous studies [ | PMC10644474 |
Limitations | neck pain | This study had a cross-sectional design, which is inappropriate for evaluating causal relationships between variables, and there is a need for future longitudinal studies to determine the risk factors of neck pain among Iranian adolescents. Furthermore, as this study was limited to Qazvin province, we may not generalize the results to the entire Iranian population, and there is a need for large-scale national studies in the future. | PMC10644474 |
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Conclusion | neck pain | The prevalence of neck pain was relatively high in our study and was associated with using mobile phones for more than six hours a day and the body position while using electronic devices. Considering that mobile phones are widely used electronic devices among adolescents, they could be a possible target for future interventions. These interventions could encompass educational efforts aimed at promoting proper posture while using electronic devices and strategies designed to reduce the amount of time spent on mobile phones, which can play a pivotal roles in alleviating the burden of neck pain among Iranian adolescents. | PMC10644474 |
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Acknowledgements | N/A. | PMC10644474 |
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Authors’ contributions | MA designed the study. SR and AY collected the data. MA supervised the study. AB analyzed the data. AH, MS, and ANA wrote the initial draft of the manuscript. All authors read and approved the final manuscript. | PMC10644474 |
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Funding | This study was not funded. | PMC10644474 |
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Data Availability | The datasets generated and/or analysed during the current study are not publicly available to keep the confidentiality of data and privacy of participants, but are available from the corresponding author on reasonable request. | PMC10644474 |
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Declarations | PMC10644474 |
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Ethics approval and consent to participate | We declare that all methods were performed in accordance with the relevant guidelines and regulations.The ethics committee of Tehran University of Medical Sciences approved the study (ethics code: IR.TUMS.IKHC.REC.1400.320). Also, participants provided informed consent prior to their participation in the study. | PMC10644474 |
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Consent for publication | N/A. | PMC10644474 |
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Competing interests | The authors declare no competing interests. | PMC10644474 |
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References | PMC10644474 |
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2. Materials and Methods | PMC10744600 |
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2.1. Trial Design and Participants | dentine lesions, Caries, caries | DENTAL CARIES, SYSTEMIC DISEASE, CARIES, CARIES, MOTOR DISORDERS | This study was designed as a double-blind three-parallel-group randomized controlled trial, in which the subject, operator, and evaluator were masked to the group assignment. It was accepted by the Comisión de Ética, Facultad de Odontología, Universidad de Buenos Aires No. FOUBA 29/05/2013-52.A sample size calculation was performed using G*Power10 (3.1 An effect size 0.10 for the new treatment was set with an α err prob = 0.05 and a Power (1-β err prob) = 0.95. The non-centrality parameter λ resulted in 14.18 with a critical χThe study was carried out between 2019 and 2022 at two schools presenting homogeneous characteristics in terms of social risk.The children (All parents/caregivers of the children received a leaflet requesting their approval to enrol their children; for those whose families decided not to be included into the trial, the children received the dental treatment needed, but their data were not evaluated. The positive reply rate was 96.7% (The inclusion criteria were children between 4 and 11 years old attending the selected schools. Exclusion criteria: children with systemic diseases or systemic disease treatments, motor disorders, and children receiving preventive measures in other public, private, or social-security dental services; one-hundred-eighty subjects were enrolled and three groups were randomly created via a systematic cluster sampling procedure using ExcelEach child underwent a clinical examination to determine dental status according to the ICDAS II criteria 14, performed under standardized conditions, using light, dental mirror, WHO probe, and magnification (2.5×). The dental exams were performed by 3 calibrated researchers (S.A., F.S., L.R.). The calibration was carried out prior to the start of the trial with the reference examiner (A.S.).The calibration strategy consisted of:Expository class (2 h) with photographs (Caries detection using extracted teeth (Clinical practice (20 h), which included the following phases:Assignment to each operator of 6 volunteer subjects who provided a balanced number of dental surfaces with ICDAS14 codes from 1 to 6.Observation and recording of the findings in an ad hoc spreadsheet, in the charge of each independent operator. The visual–tactile clinical examination was performed with frontal light, WHO probes, magnification (3.5×), and drying of surfaces with air.Re-evaluation (one-week after) of each patient by the reference examiner and recording of the findings.Inter- and intra-examiner reliability was evaluated by comparing the benchmark and the examiners’ outcomes and the percentage of agreement using Cohen’s kappa statistic for sound surfaces, enamel and dentine lesions, and caries activity.On the basis of the clinical examination, beside the ICDAS14,15 score, the CTNI (11) was also computed. The CTNI13 is based on the interaction of two axes: one based on the progression of the lesion and the other on the technological resources needed to control the risk of dental caries. The progression axis identifies the magnitude of severity and extent. The magnitude of severity component identifies the process of tissue involvement of the dental caries lesion, moving from the white spot lesion to the subsequent progression of the lesion towards cavitation. The magnitude of extension in the “oral unit” is expressed by the number of oral quadrants with visible lesions. The technological axis includes the risk component and the available technological development component. The risk component is the result of the identified variables while the technological development is based on contextualized scientific evidence and is expressed as the appropriate strategies and their application per oral unit and teeth, according to the extent recorded in the dental quadrants.No instrumentation is required for its determination. It is a visual index whose only requirement is good lighting and a clean mouth. | PMC10744600 |
2.2. Intervention | calculus, Caries lesions, caries, primary dentition | CARIES | As described above, the children were randomly divided into three different groups according to the mode of treatment:NaF varnish group (NaFV) APF in tray group (APFt) APF in toothbrush group (APFtbru) Three-row children’s brushes with soft, rounded nylon bristles, a compact head and a straight handle were used for all groups.Enrolment in each group was performed by balancing the CNTI13 categories in each group.A protocol was applied to all children, based on dental care programs to be carried out in school and dental clinics, with the aim of controlling caries lesions. All the children received teaching and control of personal oral hygiene, dietary counselling, and calculus removal. Caries lesions treatment was divided according to ICDAS code, extension, and severity of the lesions and also according to the dentition. For initial (1–2) inactive caries, active monitoring was done. For initial (1–2) active caries, the care option for primary dentition was silver diamine fluoride (SDF) 38% and for permanent dentition 5% fluoride varnish. For enamel (3) inactive caries, SDF for primary and fluoride varnish for permanent. For m (3) active caries, SDF for primary and permanent molar teeth. For extensive (4–5–6) caries, SDF or atraumatic restorative treatment (ART) were the selected care options for primary teeth according to the extension; meanwhile, for permanent teeth, ART was chosen. | PMC10744600 |
2.3. Dental Examination and Monitoring | caries lesions | Observations and clinical examinations were conducted at schools. After 12 and 24 months, the clinical examination was repeated to assess the dental status of schoolchildren following the same criteria described. The presence of new caries lesions was taken as a dependent variable. So, sound surfaces on baseline were observed for 24 months.In all children, daily brushing was performed with the same toothpaste and toothbrush, supervised by schoolteachers, with fluoride toothpaste (1400 ppm) at school. | PMC10744600 |
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2.4. Statistical Analysis | caries’ | All the data were input into a spreadsheet (Microsoft Excel 2021 for Mac, version 16.4.8). A chi-square test was performed for CTNI changes between experimental groups and follow-up examinations; moreover, tests for trends across ordered experimental groups were tested using the Cuzick’s test trends.Cox Proportional Hazards models were run to assess the factors associated with caries’ change of status. Estimates are reported in the hazard ratio (HR) and their respective 95% confidence interval (95% CI). The Kaplan–Meier estimator was endorsed to estimate the survival fraction of teeth measured as the change of status during the trial. The Efron method was used to handle tied failures. The Greenwood’s formula was used to approximate the variance of the Kaplan–Meier estimator. For all statistical analyses, the statistical significance was set at α = 0.05. | PMC10744600 |
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3. Results | caries lesions, caries | CARIES | Overall, 16,719 dental surfaces from 180 kids were included in this study. The CONSORT flow-chart is displayed in The calibration procedure was successfully performed. The level of agreement overall ranged from 90.44% for caries lesions at enamel level (ICDAS 2) to 94.50% for caries lesions at deep dentinal level (ICDAS 6). The Cohen’s kappa regarding the intra-examiners’ reliability ranged from 0.71 to 0.79.The distribution of the surfaces by caries status recorded using the ICDAS and the distribution of the subjects by CTNI are displayed in At baseline, the percentage of surfaces with no caries lesions and surfaces affected were in statistically significant association among the three groups (χThe changes of the CTNI approach during the trial in the three experimental management groups (The Kaplan–Meier survival curves underline statistically significant differences (Breslow estimator No gender or age difference was observed between groups.The multivariate analysis (Cox-Regression) underlines a significant reduction in the risk rate of caries change in the APF in the toothbrush group; the status was highlighted (HR = 0.51 95%CI = 0.33/0.81). Sex and gender were not statistically significantly associated to caries increment. | PMC10744600 |
4. Discussion | caries | DENTAL CARIES, CARIES | In this study, the use of an alternative application technique for the application of (APF) has been shown to be effective in maintaining healthy surfaces over 24 months.Different caries preventive program strategies were carried out in many countries to decrease caries prevalence and incidence [Fluoride varnishes stand out in preventing dental caries, and are widely accepted by paediatric patients, especially for children under 6 years of age. Fluoride varnishes are widely used and indicated to control caries in children [The fluoride gel/varnish applications are effective and the costs are offset in respect to restorative treatments taking into account that varnishes cost more but are more effective than gels [The present trial underlines that the use of APF on toothbrush provided better results than NaF varnish. This approach not only would be more economical than NaF varnish but also than the use of APF with trays.Studies with supervised toothbrushing programs of up to 5 years show effectiveness especially in high-risk groups. In addition, a partnership with parents and oral care and nutrition counselling are essential to the success of the intervention [A systematic review compared topical fluoride treatments with follow-up of at least one year and frequency of application. This study reaffirmed that the preventive effect of high fluoride gel on primary dentition has strong scientific evidence and is more effective when compared to permanent dentition [Urquhart et al. [As was expected, occlusal surfaces had worse survival than other dental surfaces. Evidence indicates that fissure sealants have been shown to be the most effective strategy in preventing occlusal caries in children and adolescents [Some limits of the study design need to be underlined. First of all, the study population belonged to an age range, in which it was difficult to find a complete compliance and this might have affected the dropout. The number of subjects and the inclusion criteria do not allow us to generalize the results to the general population of this age group.However, this trial presents significant strengths such as the long period of follow-up and the study design.The main clinical significance of the trial is that the results might allow paediatric dentists and health authorities to select the new procedure as an active therapeutic agent to reduce dental caries. | PMC10744600 |
Author Contributions | Conceptualization, A.L.S., A.F.S. and G.K.; methodology and data collection, A.L.S., S.F. and R.L.; formal analysis, P.S. and G.C.; investigation, A.L.S., S.F., R.L. and A.F.S.; resources, A.F.S.; data curation, A.L.S.; writing—original draft preparation, A.L.S. and G.C.; writing—review and editing, A.F.S. and G.C.; supervision, A.L.S. All authors have read and agreed to the published version of the manuscript.. | PMC10744600 |
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Institutional Review Board Statement | The study protocol was approved by the Research Ethics Committee of the University of Buenos Aires, UBACYT 20020120100324BA (13 December 2016) and registered at | PMC10744600 |
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Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10744600 |
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Data Availability Statement | The data presented in this study are available on request from the corresponding author. | PMC10744600 |
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Conflicts of Interest | The authors declare no conflict of interest. | PMC10744600 |
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Background | mucocutaneous, OLP | ORAL LICHEN PLANUS, ADVERSE EFFECT | Oral lichen planus (OLP) is a chronic mucocutaneous immunologically mediated condition that has a great adverse effect on oral functions. Corticosteroids are still the first drugs of choice used in the treatment of OLP; however, they have extensive medical side effects. The present study was carried out to assess the clinical therapeutic effect of the topical use of coenzyme Q10 (coQ10 or ubiquinol) versus topical corticosteroids in the management of symptomatic OLP and to determine whether the effect, if any, was due to the powerful antioxidant activity of coQ10. | PMC10360223 |
Subjects and methods | pain | We performed a randomized, double blinded controlled trial at the Faculty of Dentistry, Cairo University, Egypt. The study was conducted on 34 patients suffering from symptomatic OLP. Patients were randomly divided into two groups: intervention group (I),who received topical CoQ10 in the form of mucoadhesive tablets (40% CoQ10) 3 times daily for one month and control group (II),who received topical corticosteroid (kenacort in Orabase: triamcinolone acetonide 0.1% 5-g adhesive paste – dermapharm), 4 times daily for one month. Patients were evaluated at one-week intervals using the clinical parameters (score) of pain (VAS) and lesion size. Additionally, salivary levels of malondialdehyde (MDA) were detected in both groups before and after treatment using ELISA. All recorded data were analysed using independent t test, ANOVA followed by Bonferroni post hoc test for lesion size and salivary level of MDA data and Mann–Whitney U test and Friedman test for VAS data. | PMC10360223 |
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Results | pain | Both groups showed a significant reduction in pain and the size of the lesions ( | PMC10360223 |
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Conclusions | The topical use of CoQ10 mucoadhesive tablets was as effective as the topical use of triamcinolone acetonide, and its clinical effect was associated with a reduction in the salivary level of MDA. | PMC10360223 |
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Trial registration | The study protocol was registered at | PMC10360223 |
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Keywords | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10360223 |
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Introduction | immune-mediated disease of the oral mucosa, tumor necrosis, OLLs, TNF-α, GVHD, OLP | TUMOR NECROSIS, GRAFT VERSUS HOST DISEASE, ORAL LICHEN PLANUS, LYMPHOCYTIC INFILTRATION, GVHD | Oral lichen planus (OLP) is a relatively common chronic mucocutaneous inflammatory immune-mediated disease of the oral mucosa [On the other hand, oral lichenoid lesions (OLLs) are a term used to identify conditions that are clinically and histopathologically similar to OLP but with identifiable, either local or systemic causes such as numerous medications, various dental materials (mercury-containing amalgam restorations), and graft versus host disease (GVHD). Compared to the traditional signs of OLP, OLLs tend to be unilateral with histological examination showing more diffuse lymphocytic infiltration with more eosinophils, plasma cells, and colloid bodies. In addition, it resolves once the cause is removed [Multiple factors [In OLP lesions, ROS exacerbate inflammatory conditions linked to immunological pathways through the activation of NF-kB (nuclear factor kappa-light-chain-enhancer of activated B cells), a protein complex that regulates proinflammatory gene transcription, such as interleukin 2 (IL-2), tumor necrosis factor-alpha (TNF-α), MHC class 1 gene, and IL-2 receptor gene [A variety of treatments are used in the management of OLP [Co enzyme Q10 is a lipid-soluble endogenous antioxidant compound due to its ability to scavenge free radicals such as superoxide anion (O2•), hydrogen peroxide (H2O2) and hydroxyl radical (OH•) [ | PMC10360223 |
Subjects and methods | PMC10360223 |
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Study design | The present study is a randomized controlled clinical trial (two parallel groups) with an allocation ratio of 1:1. The number of patients was equal in each group. The study was conducted following the principles of the Helsinki Declaration and was approved by the Research Ethics Committee of the Faculty of Dentistry, Cairo University (code: 19923).The protocol was registered at | PMC10360223 |
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Study participants | The patients were recruited from the Diagnostic Center, as well as the Clinics of the Oral Medicine and Periodontology Department, at the Faculty of Dentistry, Cairo University, during the period from September 2019 to February 2022. According to specific inclusion and exclusion criteria | PMC10360223 |
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Inclusion criteria | OLP | SYSTEMIC DISEASE |
Patients were more than 18 years old.Patients were free from any systemic disease according to the detailed questionnaire of the modified Cornell Medical Index [Patients clinically diagnosed by a dermatologist and oral medicine specialist as suffering from OLP.Patients who agreed to the biopsy in undiagnosed casesClinical and histopathological criteria were used according to modified WHO diagnostic criteria for OLP [Patients who were willing to participate in this study (who agreed to give informed consent) and had the ability to complete the study. | PMC10360223 |
Exclusion criteria | LICHENOID REACTION |
Patients taking systemic drugs such as systemic steroids, or other immunosuppressive therapies for at least 8 weeks prior to the study.Patients treated with any oral topical medications for at least four weeks prior to the study.Patients receiving any medication either topical or systemic that could cause lichenoid reaction during the 3 months before the study.Patients with suspected restoration or drug-related lichenoid lesions.Pregnant and lactating females.
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Study interventions | The present study was conducted on 34 patients suffering from symptomatic OLP. Patients were randomly divided into two groups and received both treatments in the form of opaque sealed jars (Jar A) for adhesive tablets (Fig. Opaque sealed jar containing mucoadhesive CoQ10 tablets | PMC10360223 |
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Group I (intervention group) | Seventeen participants received topical coenzyme Q10 (ubiquinol) in the form of mucoadhesive tablets, (Fig. | PMC10360223 |
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CoQ10 mucoadhesive tablet preparation | The tablets were prepared using 120 mg coQ10 powder (in reduced form which is the antioxidant form) [Mucoadhesive CoQ10 tablets | PMC10360223 |
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Group II (control group) | Seventeen participants received topical corticosteroid (kenacorte in Orabase: triamcinolone acetonide 0.1% 5-g adhesive paste – dermapharm), (Fig. Opaque sealed jar containing triamcinolone acetonide paste | PMC10360223 |
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Study outcomes | erosion, Pain, pain | CAVITY, EROSION, ATROPHIC |
Primary outcome1.1. Pain measurement using the Visual Analogue Scale: according to Maxwell [All patients were asked to define their level of pain and discomfort by using a numerical rating from 0 to 10 (11-points), with 0 indicating "no pain", 1 to 3 indicating mild pain, 4 to 6 indicating moderate pain, 7 to 9 indicating sever pain and 10 indicating "extremely painful".1.2. Clinical improvement of the lesion, according to Thongprasom et al. [ 0 = no lesion 1 = white striae only2 = white striae and atrophic ≤ 1 cm3 = white striae with atrophic > 1 cm 4 = white striae with erosion ≤ 1 cm 5 = white striae with erosion > 1 cmThe clinical score for each patient was calculated by recording a score for each lesion in the oral cavity separately using a graduated periodontal probe, and then calculating the average of these scores.Secondary outcome2.1. Change in salivary level of malondialdehyde detected at baseline and after treatment (after 4 weeks) using ELISA.2.2. Change in Clinical global impression scale detected from baseline to the end of treatment after 4 weeks, in which the patients rated overall change in OLP symptoms during the treatment period (patient global impression of change; PGI-C), choosing 1 of 7 answers ranging from “very much better” to “very much worse.” 1 = very much better/improved, 2 = much better/improved, 3 = a little better/improved, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. | PMC10360223 |
Saliva sample collection | Whole unstimulated saliva (WUS) was collected between 8 am to 1 pm using standard techniques according to Navazesh [ | PMC10360223 |
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Determination of human malondialdehyde (MDA) in saliva using an ELISA kit (prepared by Prof. OS) | Saliva samples were centrifuged for 10 min at 4000 xg. The supernatant was separated and used for determination of MDA levels using ELISA Kit Cat No. MBS263626 provided by My BioSource (USA, NY). This kit employs the “Double Antibody Sandwich” technique. The principle of double antibody sandwich is based on the characteristics of a target analytic with more than two possible epitopes that can be identified by both the precoated capture antibody and the detection antibody simultaneously.In this kit, the precoated antibody is an anti-human MDA monoclonal antibody, while the detection antibody is a biotinylated polyclonal antibody. Samples and biotinylated antibodies are added into ELISA plate wells and washed out with PBS or TBS after their respective additions to the wells. Then, avidin-peroxidase conjugates were added to the wells. TMB substrate is used for colouration after the enzyme conjugate has already been thoroughly washed out of the wells by PBS or TBS. TMB reacts to form a blue product from the peroxidase activity, and finally turns yellow after addition of the stop solution (Color Reagent C). The color intensity and quantity of target analytics in the sample are positively correlated [ | PMC10360223 |
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Sample size calculation | Thomas | An interventional study by Thomas et al. [ | PMC10360223 |
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Randomization and allocation concealment | Simple randomization was generated using | PMC10360223 |
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Masking/blinding | Neither the statistician nor clinical outcome assessor (associate prof. AH) were aware of which medication was being administered, thus yielding a double-blind controlled study. | PMC10360223 |
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Data collection and statistical analysis | All data collected from patients using clinical parameters were recorded electronically for statistical analysis. Categorical data are presented as frequencies (n), and percentages (%), and the chi square test was used for the analysis. Quantitative data were explored for normality using Kolmogorov–Smirnov and Shapiro–Wilk tests and are presented as the mean and standard deviation (SD). Parametric data of age, lesion size and salivary level of MDA were analyzed using independent t test for intergroup comparisons and repeated measures ANOVA followed by Bonferroni post hoc test. VAS data showed a nonparametric distribution so they were analyzed using the Mann -Whitney U test for intergroup comparisons and the Friedman test of repeated measures for intragroup comparisons. When the Friedman test was significant, it was followed by multiple pairwise comparisons utilizing the Wilcoxon signed rank test with Bonferroni correction. The significance level was set at | PMC10360223 |
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Results | thirty-four, OLP | ADVERSE EFFECTS, SYSTEMIC DISEASE, RECRUITMENT | During the recruitment phase, 36 patients were assessed for eligibility from September 2019 to February 2022. Two patients did not meet the inclusion criteria due to their chronic systemic diseases. Only thirty-four participants were eligible for inclusion. All patients gave written informed consent and were randomly allocated equally to the intervention group (CONSORT flow diagram of participantsDemographic data of age and genderClinical characteristics of symptomatic OLP lesions in both groupsAfter the 4 week follow up period, both the intervention group and control group showed a significant difference in VAS scores at different follow-up intervals (Mean and standard deviation (SD) of VAS scores in both groups and different follow-up intervalsDifferent superscript letters within the same column indicate a statistically significant difference*; significant (Regarding the (mean ± SD) value of lesion size using the (Thongprasom scale), the intervention group showed a significant difference between lesion sizes at different follow-up intervals (Mean and standard deviation of lesion size in (Thongprasom scale) in both groups and different follow-up intervalsDifferent superscript letters within the same column indicate a statistically significant difference*; significant (Line chart showing average lesion size in (Thongprasom scale) in different follow-up intervalsIn addition to the clinical assessment, the salivary level of malondialdehyde (pg/ml) before and after the treatment in both groups was assessed which showed that the intervention group value of salivary level of malondialdehyde (pg/ml) measured before (7.08 ± 4.46) was higher than value measured after treatment (5.92 ± 2.73), however the difference was not statistically significant (Mean and standard deviation of salivary level of malondialdehyde (pg/ml) in both groups and different follow-up intervals
Line chart showing the average salivary level of malondialdehyde (pg/ml) at different follow-up intervalsFinally, PGI-C assessing patient experience with their OLP at end of dosing also showed clinically meaningful improvements in both groups with 12/17 patients (70.5%) in mucoadhesive Coq10 intervention group and 14/17 patients (82.3%) in the control group reporting their OLP feeling much better or very much better.Regarding drug safety in both groups, none of the participants in either group reported any temporary or permanent adverse effects with either treatment during the 4 week follow up period. | PMC10360223 |
Discussion | pain, OLP | ADHESION, ADVERSE DRUG EFFECTS, OXIDATIVE STRESS | The chronic nature of OLP, prolonged course of treatment, and frequent exacerbation of the condition increase the incidence of steroid side effects [In addition to the antioxidant and anti-inflammatory effects of CoQ10, its topical use in the form of mucoadhesive tablets in the present study has many advantages including intimate contact with the target mucous membrane, sustained drug release, increased drug absorption, and bioavailability, avoidance of enzymatic degradation in the GIT, and decreased adverse drug effects [The mucoadhesiveness of these tablets is gained from the use of mucoadhesive carbapol polymer that rapidly swells when touching the target area, thus providing sustained and controlled release of the drug from 6–8 h, and a strong mucosal adhesion effect [Up to our knowledge, the current study is the first randomized control clinical trial evaluating the effectiveness of topical use of CoQ10 in the management of symptomatic OLP. Consequently, no similar previous studies are available for comparison with our results. Shoukheba and Elgendy’s [The results of the current study showed that the topical use of CoQ10 mucoadhesive tablets significantly reduced both pain sensation and clinical signs with maximum clinical improvement at the fourth week and no significant differences when compared with the results of topical corticosteroid. The effective role of the topical use of CoQ10 was also seen in the study conducted by Shoukheba and Elgendy [In addition to the clinical assessment, the salivary levels of MDA in both groups decreased after treatment with no significant difference. Therefore, we could assume that the clinical improvement in both groups might be due to the anti-inflammatory effect of both corticosteroids [However, it is expected that corticosteroids would have a more potent anti-inflammatory effect than CoQ10. Thus, it seems that while the decrease in oxidative stress in the case of triamcinolone could be totally a result, in the case of CoQ10, it is partly a result and partly due to the powerful antioxidant role of CoQ10 which was previously detected by Ushikoshi-Nakayama et al. [Topical CoQ10 has been previously investigated in other oral conditions, such as periodontal and gingival conditions, and showed a great clinical reduction in the inflammatory condition after a few weeks [Comparing our study with other studies using antioxidant agents in the management of OLP, such as selenium -ACE [ | PMC10360223 |
Conclusions | pain | OXIDATIVE STRESS |
Topical application of mucoadhesive CoQ10 tablets on symptomatic OLP lesions leads to significant pain relief and clinical improvement of the condition in addition to decreasing the salivary levels of one of the markers of oxidative stress (MDA).CoQ10 in a mucoadhesive formula is as effective as the standard treatment triamcinolone acetonide in reducing pain scores and lesion size in OLPTopical CoQ10 as an antioxidant and anti-inflammatory agent together with its analgesic effect is a safe treatment modality for symptomatic OLP, with no apparent side effects | PMC10360223 |
Recommendations | OLP | REMISSION |
Studies with larger sample sizes are needed to conclude the effective role of CoQ10 in the management of symptomatic OLP.Different concentrations of CoQ10 need to be used to reach the optimum dose required to achieve optimum management of OLP with no side effects.The period between lesion remission and exacerbation for CoQ10 should be measured.Evaluation of CoQ10 use for a long duration is also needed. | PMC10360223 |
Acknowledgements | The authors of the study would like to express the greatest thanks to all the staff members of the Oral Medicine Department, Faculty of Dentistry, and Cairo University for their cooperation, kind feelings and for sparing no effort in helping us, as well as many thanks to Mepaco_Arab Co. For Pharmaceuticals and Medicine for supplying us with the powder of Co enzyme Q10 .Finally, we would like to express a lot of thanks to all patients who participated in the study. | PMC10360223 |
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Authors’ contributions | A.H. | M.A. responsible for the funding and undergoing the clinical and theoretical work of the trial, collecting data, clarification, conclusions and drafting the manuscript. F.Z. responsible for patients’ randomization, providing guidance through the clinical work, revising the theoretical part and help with the conclusions and completion of the data. A.H. responsible for clinical assessment of patients, cases selection, clinical diagnosis as well as help in writing the manuscript. O.S. responsible for Biochemical assessment of salivary samples using enzyme-linked immunosorbent assay (ELISA), interpretation of results and drawing conclusions. A.A. responsible for Coenzyme Q10 mucoadhesive tablets preparation. All authors read and approved the final manuscript. | PMC10360223 |
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Funding | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). Self-funded. | PMC10360223 |
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Availability of data and materials | The datasets used and/or analyzed during the current study are not publicly available due [for better patient data confidentiality] but are available from the corresponding author on reasonable request. | PMC10360223 |
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Declarations | PMC10360223 |
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Ethics approval and consent to participate | The study was conducted following the principles of the Helsinki Declaration and was approved by the Research Ethics Committee of the Faculty of Dentistry, Cairo University (code: 19923). All patients were informed about the nature and objectives of the study. All participants read, approved, and signed a written informed consent form that was reviewed by the ethics committee of scientific research – Faculty of Dentistry– Cairo University. | PMC10360223 |
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Consent for publication | Not applicable. | PMC10360223 |
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Competing interests | The authors declare no competing interests. | PMC10360223 |
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References | PMC10360223 |
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Background | Social media has emerged as an effective tool to mitigate preventable and costly health issues with social network interventions (SNIs), but a precision public health approach is still lacking to improve health equity and account for population disparities. | PMC10267788 |
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Objective | This study aimed to (1) develop an SNI framework for precision public health using control systems engineering to improve the delivery of digital educational interventions for health behavior change and (2) validate the SNI framework to increase organ donation awareness in California, taking into account underlying population disparities. | PMC10267788 |
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Methods | PID | This study developed and tested an SNI framework that uses publicly available data at the ZIP Code Tabulation Area (ZCTA) level to uncover demographic environments using clustering analysis, which is then used to guide digital health interventions using the Meta business platform. The SNI delivered 5 tailored organ donation–related educational contents through Facebook to 4 distinct demographic environments uncovered in California with and without an Adaptive Content Tuning (ACT) mechanism, a novel application of the Proportional Integral Derivative (PID) method, in a cluster randomized trial (CRT) over a 3-month period. The daily number of impressions (ie, exposure to educational content) and clicks (ie, engagement) were measured as a surrogate marker of awareness. A stratified analysis per demographic environment was conducted. | PMC10267788 |
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Results | Four main clusters with distinctive sociodemographic characteristics were identified for the state of California. The ACT mechanism significantly increased the overall click rate per 1000 impressions (β=.2187; | PMC10267788 |
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Conclusions | The proposed SNI framework, with its ACT mechanism, learns and delivers, in real time, for each distinct subpopulation, the most tailored educational content and establishes a new standard for precision public health to design novel health interventions with the use of social media, automation, and machine learning in a form that is efficient and equitable. | PMC10267788 |
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Trial Registration | ClinicalTrials.gov NTC04850287; https://clinicaltrials.gov/ct2/show/NCT04850287 | PMC10267788 |
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Introduction | PID | Health care expenditures, especially in the United States, continue to rise [Social network interventions (SNIs) enable the development of large-scale and tailored educational interventions but also need to account for population disparities. SNIs have been increasingly adopted for health behavior change [The design of SNIs with real-time monitoring and tailored reinforcement of educational contents requires a precision public health approach with the use of automation. Precision public health interventions are designed to deliver the right intervention to the right recipients [Automatic and efficient SNIs depend on controllability with high-resolution assessments. The former provides acceptable dynamic performance to a system by using control based on feedback [We proposed a SNI framework for health-behavior change using an Adaptive Content Tuning (ACT) mechanism to increase awareness, taking into account population disparities. For this purpose, we used a proportional-integral-derivative (PID) controller as the ACT mechanism, which is a simple and effective control mechanism widely used in industry and other scenarios [ | PMC10267788 |
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Methods | PMC10267788 |
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Overview | The SNI framework is a precision digital education approach developed to enable, test, and improve large-scale and equitable access to health literacy by automating four components: (1) population stratification into demographic environments, (2) cluster-randomized assignment, (3) personalized digital content delivery, and (4) ACT (. Illustration of the social network intervention’s (SNI) 4 components diagram. The framework stratifies the population into demographic environments based on socioeconomic data (population stratification). In a cluster-randomized trial research design, the ZCTAs from the uncovered clusters are randomly assigned to optimal, nonoptimal, and control arms (cluster-randomized assignment). The optimal and nonoptimal arms are targeted with digital content through social media (digital content delivery). To enable optimal SNI, an adaptive content tuning component adjusts the digital content daily budget to guarantee an efficient intervention (adaptive content tuning). ZCTA: zip code tabulation area. | PMC10267788 |
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Study Design, Study Setting, and Participants | This was a 3-month, prospective, cluster randomized trial (CRT) to evaluate the engagement performance of optimal and nonoptimal SNIs on health educational content delivered as ads using Meta’s Business Platform (Facebook) [The study setting was the Meta Business Platform [ | PMC10267788 |
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Study Outcome | The main study outcome was the number of link clicks per 1000 impressions (C/I) on the health educational content, which is a measure of social media engagement retrieved from Facebook and used as a surrogate marker of awareness [ | PMC10267788 |
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Study Variables | The study variables were the use of ACT mechanism optimization (optimal and nonoptimal) and the type of demographic environment (4 uncovered clusters). The ACT mechanism was applied to the optimal group, and the demographic environments are defined at the ZCTA level. | PMC10267788 |
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