title: Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. Efficacy of conventional treatment with composite resin and atraumatic restorative treatment in posterior primary teeth: study protocol for a randomised controlled trial The Hall Technique; a randomized controlled clinical trial of a novel method of managing carious primary molars in general dental practice: acceptability of the technique and outcomes at 23 months Atraumatic Restorative Treatment compared to the Hall Technique for occluso-proximal cavities in primary molars: study protocol for a randomized controlled trial One-year evaluation of atraumatic restorative treatment and minimum intervention techniques on primary teeth. Self-report of pain in children treated according to the atraumatic restorative treatment and the conventional restorative treatment--a pilot study. Acceptability of different caries management methods for primary molars in a RCT. Minimal intervention dentistry for early childhood caries and child dental anxiety: a randomized controlled trial The influence of restorative treatment approaches and the use of local analgesia, on the children's discomfort. Trajectories of dental anxiety in a birth cohort. Influence of residual caries and cervical gaps on the survival rate of class II glass ionomer restorations Child oral health-related quality of life and early childhood caries: a non-inferiority randomized control trial.
abstract: The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement aims to improve the reporting of r and omized controlled trials ( RCTs ) ; however , it lacks guidance on the reporting of patient-reported outcomes ( PROs ) , which are often inadequately reported in trials , thus limiting the value of these data . In this article , we describe the development of the CONSORT PRO extension based on the method ological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research ( EQUATOR ) Network . Five CONSORT PRO checklist items are recommended for RCTs in which PROs are primary or important secondary end points . These recommendations urge that the PROs be identified as a primary or secondary outcome in the abstract , that a description of the hypothesis of the PROs and relevant domains be provided ( ie , if a multidimensional PRO tool has been used ) , that evidence of the PRO instrument 's validity and reliability be provided or cited , that the statistical approaches for dealing with missing data be explicitly stated , and that PRO-specific limitations of study findings and generalizability of results to other population s and clinical practice be discussed . Examples and an up date d CONSORT flow diagram with PRO items are provided . It is recommended that the CONSORT PRO guidance supplement the st and ard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes . Improved reporting of PRO data should facilitate robust interpretation of the results from RCTs and inform patient care Introduction Despite the widespread acceptance of conventional treatment using composite resin in primary teeth , there is limited evidence that this approach is the best option in paediatric clinics .  Atraumatic restorative treatment ( ART ) using high-viscosity glass ionomer cement has gradually become more popular because it performs well in clinical studies , is easy to h and le and is patient friendly . Therefore , the aim of this r and omised clinical trial study is to compare the restoration longevity of conventional treatment using composite resin with that of ART in posterior primary teeth . As secondary outcomes , cost-efficacy and patient self-reported discomfort will also be tested . Methods and analysis Children aged 3–6 years presenting with at least one occlusal and /or occlusal-proximal cavity will be r and omly assigned to one of two groups according to the dental treatment : ART ( experimental group ) or composite resin restoration ( control group ) . The dental treatment will be performed at a dental care trailer located in an educational complex in Barueri/SP , Brazil . The unit of r and omisation will be the child . A sample size of 240 teeth with occlusal cavities and 188 teeth with occlusal-proximal cavities has been calculated . The primary outcome will be restoration longevity , which will be clinical ly assessed after 6 , 12 , 18 and 24 months by two examiners . The duration of the dental treatment and the cost of all material s used will be considered when estimating the cost-efficacy of each treatment . Individual discomfort will be measured after each dental procedure using the Facial Scale of Wong-Baker . Ethics and dissemination This clinical trial was approved by the local ethics committee from the Faculty of Dentistry of the University of São Paulo ( registration no. 1.556.018 ) . Participants will be included after their legal guardians have signed an informed consent form containing detailed information about the research . Trial registration number www . clinical trials.gov , NCT02562456 ; Pre- results Background Scotl and has high levels of untreated dental caries in primary teeth . The Hall Technique is a simplified method of managing carious primary molars using preformed metal crowns ( PMCs ) cemented with no local anaesthesia , caries removal or tooth preparation . This study compared the acceptability of the  Hall Technique  for children , their carers , and dentists , and clinical outcomes for the technique , with conventional restorations . Methods General dental practice based , split mouth , r and omized controlled trial ( 132 children , aged 3–10 ) . General dental practitioners ( GDPs , n = 17 ) in Tayside , Scotl and ( dmft 2.7 ) placed conventional ( Control ) restorations in carious primary molars , and Hall Technique PMCs on the contralateral molar ( matched clinical ly and radiographically ) . Dentists ranked the degree of discomfort they felt the child experienced for each procedure ; then children , their carers and dentists stated which technique they preferred . The teeth were followed up clinical ly and radiographically . Results 128 conventional restorations were placed on 132 control teeth , and 128 PMCs on 132 intervention teeth . Using a 5 point scale , 118 Hall PMCs ( 89 % ) were rated as no apparent discomfort up to mild , not significant ; for Control restorations the figure was 103 ( 78 % ) . Significant , unacceptable discomfort was recorded for two Hall PMCs ( 1.5 % ) and six Control restorations ( 4.5 % ) . 77 % of children , 83 % of carers and 81 % of dentists who expressed a preference , preferred the Hall technique , and this was significant ( Chi square , p < 0.0001 ) . There were 124 children ( 94 % of the initial sample ) with a minimum follow-up of 23 months . The Hall PMCs outperformed the Control restorations  : a ) ' Major ' failures ( signs and symptoms of irreversible pulpal disease ) : 19 Control restorations ( 15 % ) ; three Hall PMCs ( 2 % ) ( P < 0.000);b ) ' Minor ' failures ( loss of restoration , caries progression ) : 57 Control restorations ( 46 % ) ; six Hall PMCs ( 5 % ) ( P < 0.000)c ) Pain : 13 Control restorations ( 11 % ) ; two Hall PMCs ( 2 % ) ( P = 0.003 ) . Conclusion The Hall Technique was preferred to conventional restorations by the majority of children , carers and GDPs . After two years , Hall PMCs showed more favourable outcomes for pulpal health and restoration longevity than conventional restorations . The Hall Technique appears to offer an effective treatment option for carious primary molar teeth . Trial registration numberCurrent Controlled Trials IS RCT N47267892 – A r and omized controlled trial in primary care of a novel method of using preformed metal crowns to manage decay in primary molar teeth : the Hall technique Background In many parts of the world , school-age children have high dental treatment needs ; however , there is often low , or no , dental care provision . Although Atraumatic Restorative Treatment ( ART ) was developed to address this , its survival rate in occluso-proximal lesions is low . An alternative , the Hall Technique ( HT ) has shown better relative outcomes for occluso-proximal lesions , but has not been directly compared to ART or tested in field setting s. This trial will compare ART and the HT for the most clinical ly- and cost-effective strategy for managing occluso-proximal lesions in primary molars , in a school setting , using low-technology and child-friendly dental techniques . Methods / Design This two-arm , parallel group , patient-r and omized controlled , superiority trial will have treatment provided in schools . Schoolchildren ( n = 124 , age 6–8 ) with at least one occluso-proximal carious primary molar lesion will have r and om allocation to treatment with ART or HT . Baseline measures and outcome data will be assessed through participant report , clinical examination and parent report/ question naires . The primary outcome is survival rate , a composite measure of absence of Minor Failures ( a defect in the restoration/crown , but not interfering with tooth health ) and Major Failures ( signs or symptoms of irreversible pulp damage , such as dental fistula/abscess , tooth fracture or failures that can not be repaired ) . Secondary outcomes are : ( 1 ) child-reported discomfort , ( 2 ) childrens ’ and ( 3 ) parents ’ concerns around dental appearance and ( 4 ) acceptability of treatments , ( 5 ) occlusal-vertical dimensions ( OVD ) changes , ( 6 ) plaque index , ( 7 ) gingival health , ( 8) decayed , missing , filled teeth in permanent teeth (DMFT)/decayed , missing , filled teeth in primary teeth ( dmft ) , ( 9 ) oral health-related- quality of life , reported by children and parents/caregivers , ( 10 ) the incremental cost-effectiveness , and ( 11 ) operator effect . A trained and calibrated examiner will evaluate the treated teeth after 1 week , then 1 , 6 , 12 , 24 and 36 months post treatment . Kaplan-Meier and Cox regression tests will be used to investigate the primary outcome . The Mann-Whitney or t test , Friedman test , paired t test or Wilcoxon test and Ordinal Logistic Regression Analysis will be used to analyze the secondary outcomes . Discussion The results of this trial will support decision-making by clinicians and policy-makers for managing occluso-proximal lesions in setting s with constrained re sources and limited dental access . Trial registration www . clinical trials.gov , NCT02569047 , registered 5 October 2015 Atraumatic restorative treatment ( ART ) and minimal intervention treatment ( MIT ) techniques were evaluated under field conditions in 5 regions of the Western Cape Province of South Africa , where caries prevalence exceeds 60 % and remains mostly untreated . The purpose of the study was to compare and evaluate results of  ART and MIT techniques in the primary dentition of 6 - 9 year-old schoolchildren using  glass-ionomer ( GI ) ( Fuji IX ) and compomer ( Dyract AP ) material s. At baseline 401 children were treated , and 1,119 restorations  placed by 5 calibrated dentists , 53 % with ART ( using h and instruments only ) and 47 % with MIT ( minimal use of slow h and -piece ) techniques . Evaluations were done with a CPI periodontal probe to measure marginal defects and to detect decay . A pain assessment for the restoration procedures indicated that 80 % of subjects experienced no pain , 18 % discomfort and slight pain , and 2 % required local anaesthetic . After one year 90.5 % of subjects and 80 % of restorations were followed up ( 11.1 % lost as a result of exfoliation ) ; of these restorations 86 % were clinical ly acceptable ( 84.1 % of the ART and 88 % of the MIT ) . With the art technique 82.7 % of GI restorations and 85.6 % , of compomer restorations were acceptable . With the MIT technique 86.5 % of GI restorations and 89.9 % of compomer restorations were acceptable . Success of restorations per region varied significantly : regions 1 and 2 - 90 % , region 3 - 80 % , region 4 - 70 % and region 5 - 95 % . There were no significant statistical differences in respect of material s or methods employed . ART and MIT techniques were well accepted as complementary caries approaches by operators . One-year results show that ART and MIT techniques were successful , substantiating its use for the primary dentition in areas with high caries prevalence . Longer-term assessment s are required OBJECTIVE To compare the level of pain among children treated according to the Atraumatic Restorative Treatment ( ART ) and the Conventional Restorative Treatment ( CRT ) .  STUDY DESIGN Forty children of both genders , 4- to 7-years old , presenting Class I cavitated dentin lesions in primary molars were r and omly allocated to 2 groups . One group ( CRT ) received conventional restorative treatment using rotary instruments , while in the other one ( ART ) h and instruments were used to perform the restorations . All children were treated by the same operator A high-viscosity glass-ionomer cement ( Fuji IX ) was used to restore the teeth in both groups . Children 's pain was measured at the end of the first restorative treatment session using the Wong-Baker FACES Pain Rating Scale ( dependent variable ) . Age , gender , treatment time and treatment group were independent variables . ANOVA and ANCOVA tests were used to analyze the data . RESULTS The CRT procedure took longer than the ART procedure ( p < 0.001 ) . Children from the ART group reported less pain than those from the CRT group ( p = 0.0037 ) . Four year olds reported more pain than 5- to 7-year olds ( p < 0.0001 ) in both groups . CONCLUSIONS Restorations placed using ART were less time consuming , children felt less pain when the ART approach was used , and younger children ( 4-years ) reported more pain than the older ones for both restorative treatments BACKGROUND More conservative techniques for managing dental caries including ' partial ' and ' no caries removal ' have been increasingly of interest . AIM To compare children 's  behaviour and pain perception , also technique acceptability ( parents and dentists ) , when approximal dentinal lesions ( ICDAS 3 - 5 ) in primary molars ( 3 - 8-year-olds ) were managed with three treatment strategies ; conventional restorations ( CR ) , hall technique ( HT ) , and non-restorative caries treatment ( N RCT ) . DESIGN Secondary care-based , three-arm parallel-group , r and omised controlled trial , with 169 participants treated by 12 dentists . OUTCOME MEASURES child 's pain perception ( Visual Analogue Scale of Faces ) ; behaviour ( Frankl scale ) ; and parents ' and dentists ' treatment opinions ( 5-point Likert scales ) . RESULTS Children showed more negative behaviour in the CR group ( 37 % ) compared to N RCT ( 21 % ) and HT ( 13 % ) ( P = 0.047 , CI = 0.41 to 0.52 ) . Pain intensity was rated ' very low ' or ' low ' in 88 % N RCT , 81 % HT , and 72 % CR ( P = 0.11 , CI = 0.10 to 0.12 ) . N RCT and HT were ' very easy ' or ' easy ' to perform for > 77 % of dentists , compared to 50 % in CR group ( P < 0.000 ) . There were no statistically significant differences in parents ' rating of their child 's level of comfort ( P = 0.46 , CI = 0.45 to 0.48 ) . CONCLUSIONS Dentists reported more negative behaviour in CR group . For all techniques , children 's pain perception and dentist/parent acceptability were similar BACKGROUND To compare changes in  child dental anxiety  after  treatment for early childhood caries ( ECC ) using two treatment approaches . METHODS Children with ECC were r and omized to test ( atraumatic restorative treatment (ART)-based approach ) or control ( st and ard care approach ) groups . Children aged 3 years or older completed a dental anxiety scale at baseline and follow up . Changes in child dental anxiety from baseline to follow up were tested using the chi-squared statistic , Wilcoxon rank sum test , McNemar 's test and multinomial logistic regression . RESULTS Two hundred and fifty-four children were r and omized ( N = 127 test , N = 127 control ) . At baseline , 193 children completed the dental anxiety scale , 211 at follow up and 170 completed the scale on both occasions . Children who were anxious at baseline ( 11 % ) were no longer anxious at follow up , and 11 % non-anxious children became anxious . Multinomial logistic regression found each increment in the number of visits increased the odds of worsening dental anxiety ( odds ratio ( OR ) , 2.2 ; P < 0.05 ) , whereas each increment in the number of treatments lowered the odds of worsening anxiety ( OR , 0.50 ; P = 0.05 ) . CONCLUSIONS The ART-based approach to managing ECC result ed in similar levels of dental anxiety to the st and ard treatment approach and provides a valuable alternative approach to the management of ECC in a primary dental care setting AIM The aim is to investigate possible differences in discomfort during treatment with the atraumatic restorative treatment ( ART ) or the Conventional restorative method with and without local analgesia ( LA ) . METHODS The study group consisted of 6 and 7 year old children with no dental experience ( mean age 6.98 , SD + /- 0.52 ) r and omly divided into four treatment groups : Conventional method with and without LA and ART with and without LA . One or two proximal lesions in primary molars were treated . The heart rate and the behaviour ( Venham ) were measured . STATISTICS Statistical analysis was performed in SPSS version 10.0 . RESULTS In a first session 300 children were treated and 109 children for a second time in the same way as at the first visit . During the first session ART without LA gave the least discomfort while the Conventional method without LA gave the most discomfort . During the second treatment the least discomfort was observed with ART without LA and the most discomfort in the Conventional way with LA . CONCLUSION There is a constant preference for h and instruments ; the bur is increasingly accepted . The experience with LA is the reverse OBJECTIVE To examine predictors of dental anxiety trajectories in a longitudinal study of New Zeal and ers . METHODS Prospect i ve study of a complete birth cohort born in 1972/73 in Dunedin , New Zeal and , with dental anxiety scale ( DAS ) scores and dental utilization determined at ages 15 , 18 , 26 and 32 years . Personality traits were assessed at a superfactor and ( more fine-grained ) subscale level via the Multidimensional Personality Question naire at age 18 years . Group-based trajectory analysis was used to identify dental anxiety trajectories . RESULTS DAS scores from at least three assessment s were available for 828 participants . Six dental anxiety trajectories were observed : stable nonanxious low ( 39.6 % ) ; stable nonanxious medium ( 37.9 % ) ; recovery ( 1.6 % ) ; adult-onset anxious ( 7.7 % ) ; stable anxious ( 7.2 % ) and adolescent-onset anxious ( 5.9 % ) . Multivariate analysis showed that males and those with higher DMFS at age 15 years were more likely to be in the stable nonanxious low trajectory group . Membership of the stable nonanxious medium group was predicted by the dental caries experience at age 15 years . Participants who had lost one or more teeth between ages 26 and 32 years had almost twice the relative risk for membership of the adult-onset anxious group . Personality traits predicted group membership . Specifically , high scorers ( via median split ) on the ' stress reaction ' subscale had over twice the risk of being in the stable anxious group ; low scorers on the traditionalism subscale were more likely to be members of the recovery trajectory group ; and high scorers on the ' social closeness ' subscale had half the risk of being in the stable anxious group . Dental caries experience at age 5 years was also a predictor for the stable anxious group . Membership of the late-adolescent-onset anxious group was predicted by higher dental caries experience by age 15 years , but none of the other predictors was significant . CONCLUSION Six discrete trajectories of dental anxiety have been observed . Some trajectories ( totalling more than 90 % of the cohort ) had clear associations with external influences , but others were more strongly associated with characteristics such as personality traits . A mix of both influences was observed with only the stable anxious dental anxiety trajectory Aim : To assess the influence of different variables on the survival of class II glass ionomer cements ( GIC ) in a clinical study among 6–7 year old schoolchildren in and around Dar es Salaam , Tanzania . Methods : 217 children were r and omly divided into three groups . In the conventional group , Class-II cavities were excavated with burs , in the ART group they were excavated with h and instruments and in the Carisolv ™ group excavation took place with a chemical solution and special blunt h and instruments . The preparations in all groups were restored with h and mixed GIC ( Fuji IX ) by 4 operators . After restoration , residual caries and cervical gaps were assessed on bite-wing radiographs . The quality of the restorations was established and the survival rate determined in two subsequent evaluations . Results : 195 children ( 90 % ) were present at the first evaluation which took place after 7 months and 194 ( 89 % ) were present at the second evaluation , after one year . At the first evaluation the survival rate of the ART-restorations  was 38 % , of the conventional restorations 50 % , and of the Carisolv ™ restorations  35 % . Survival rates at the time of the second evaluation were 30 % , 42 % and 28 % respectively . The differences between the three treatment groups were , however , not significant ( p=0.200 at t=1 and p=0.247 at t=2 ) . In the first evaluation 161 bitewings were available of the 195 restorations , while for the second evaluation 130 . There was no significant relation between residual caries and the success/failure rate ( p=0.140 at t=1 and p=0.201 at t=2 ) . Also , cervical gaps appeared to have no relation with the failure rate ( p=0.057 at t=1 and p=0.833 at t=2 ) However , together those variables have a significant influence on the survival rate ( p = 0.025 ) . Conclusion : The combination of two variables ( residual caries and cervical gaps ) has considerable influence on the survival rate of class II GIC restorations compared to each variable alone BACKGROUND The aim of this study was to compare changes in  child oral health-related quality of life ( COHRQoL ) after treatment for early childhood caries ( ECC ) using two alternative treatment approaches . METHODS A r and omized control trial with r and om allocation of parent/child dyads with ECC to test ( minimum intervention ) or control ( st and ard care ) .  Participating parents completed the Early Childhood Oral Health Impact Scale ( ECOHIS ) at baseline and follow-up . Changes in ECOHIS scores and extent of COHRQoL impacts between and within groups were tested using the chi-squared statistic for groups , Wilcoxon 's rank-sum test , and matched-pairs signed-rank test . RESULTS Two hundred and fifty-four children were r and omized ( test = 127 ; control = 127 ) . At baseline ,  mean ECOHIS  score 11.1 , sd 8.2 ; mean age = 3.8 years , sd 0.90 ; mean dmft = 4.9 , sd 4.0 ; and 59 % male . After a mean interval of 11.4 months , 210 children were followed-up and returned a completed question naire ( test = 111 ; control = 99 ) . There was no significant difference in COHRQoL changes between test and control . For all the children combined , there were significantly fewer impacts at follow-up in the child and family domains and the total ECOHIS , Wilcoxon signed-rank test , p < 0.05 . CONCLUSIONS COHRQoL improved with primary dental care for ECC , and there was no statistically significant difference between test and control in the extent of the improvement
target: Regarding pain , there was a trend for treatments without rotary instruments and local anesthesia to be less frequently reported as painful .
  No statistical difference was found intragroup nor among treatments for OHRQoL. CONCLUSIONS Anxiety and pain are directly related with more invasive restorative treatments .
  On the other h and , quality of life is not improved regardless of the restorative technique used .
background: BACKGROUND Despite the increasing number of studies evaluating patient reported outcome measures ( PROs ) , there is no clearness regarding which restorative treatment offers major benefits based on the pediatric patient perspective .
  AIM To compare different restorative techniques in pediatric dentistry regarding patient-reported outcomes .