## Protocol Section
### Identification Module
**NCT ID:** NCT06425328

**Brief Title:** Effect of Nutritional Habits on Oral Microbiota in Adolescents

**Official Title:** Effect of Nutritional Habits on Oral Microbiota in Adolescents

#### Organization Study ID Info
**ID:** ErciyesU-BVD-BAG-01
#### Organization
**Class:** OTHER
**Full Name:** TC Erciyes University
### Status Module
#### Completion Date
**Date:** 2023-11-17

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-11-17

**Type:** ACTUAL

#### Start Date
**Date:** 2023-06-14

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** TC Erciyes University

#### Responsible Party

**Investigator Affiliation:** TC Erciyes University

**Investigator Full Name:** Betül Cicek

**Investigator Title:** PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aim of this study is to examine the relationship between oral microbiota and eating habits, sleep quality and hedonic hunger in adolescents.

**Detailed Description:** Oral microbiota; While it is associated with systemic diseases such as obesity, diabetes and cancer, it is also associated with oral diseases such as oral cancers, tooth decay and gum diseases. Nutrition is seen as an important factor in maintaining oral health. In particular, the amount and frequency of sugar consumption, the type and consistency of food, the frequency of eating, the consumption of cariogenic foods with other foods and the duration of carbohydrates remaining on the teeth are among the factors that affect oral health. The aim of this study is to examine the relationship between oral microbiota and eating habits, sleep quality and hedonic hunger in adolescents. The study is planned to be carried out in 4 stages. First stage; A survey form will be filled out that questions general information about children, oral health practices, nutritional habits and frequency of food consumption. In the second stage; Children's anthropometric measurements (body weight (kg), height (cm), waist circumference (cm) will be taken and bioelectrical impedance analysis (BIA) results will be recorded. In the third stage, oral examinations of the children will be performed. In the final stage, saliva samples of the children will be collected. Bacteria Logarithmic values will be used when comparing the concentrations between groups. The suitability of the parameters to normal distribution will be evaluated with q-q graphs and Shapiro-Wilk test. Student t test will be used for variables that comply with normal distribution and Mann Whitney U test will be used for changes that do not comply with normal distribution. The relationship will be evaluated with the Spearman or Pearson correlation test according to the normality distribution. IBM SPSS (Statistical Package for Social Sciences) 22.0 package program will be used when evaluating the data obtained as a result of the study. While examining the hypothesis tests, α = 0.05 and accordingly the confidence interval will be determined as 95%. It will be evaluated at p\<0.05 level. In order to enable healthy adolescents to reach a good standard of living, there is a need for a more accurate understanding of the relationship between oral microbiota, nutrition and sleep. As a result of this study, it is aimed to reveal the relationship between oral microbiota and eating habits, sleep quality and hedonic hunger in adolescents.

### Conditions Module

**Conditions:**

- Nutrition, Healthy

- Adolescent Behavior

- Microbial Colonization

**Keywords:**

- adolescent

- Nutritional Sciences

- Oral Health

### Design Module

#### Bio Spec

**Description:** Saliva samples were taken from all participants.

**Retention:** NONE_RETAINED

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. Accordingly, those with a BMI z score below -1 SD are defined as underweight.

**Label:** Underweight

#### Arm Group 2

**Description:** BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. Accordingly, BMI z scores between -1 SD +1 SD are defined as normal weight.

**Label:** Normal weight

#### Arm Group 3

**Description:** BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. Accordingly, those with a BMI z score between +1 SD +2 SD are defined as overweight

**Label:** Overweight

#### Arm Group 4

**Description:** BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. Accordingly, those with a BMI z score above +2 SD are defined as obese.

**Label:** Obese

### Outcomes Module

#### Primary Outcomes

**Description:** For oral microbiota analysis, saliva samples were taken from children who had brushed their teeth in the morning and had not consumed any food until 2 hours before, and microbiological procedures were performed. Saliva samples taken from all patients participating in the study were stored at -80°C until analysis. Saliva samples collected during the research process were transported to the center where the analyzes were carried out by preserving the cold chain, and DNA isolation and sequence analysis were carried out together with molecular biologists.

**Measure:** Oral microbiome characteristics

**Time Frame:** 1 month

#### Secondary Outcomes

**Description:** BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19.

**Measure:** Anthropometric Measurements

**Time Frame:** Within 10 minutes during the meeting with the participant

**Description:** On the first day of the food consumption record, a 24-hour retrospective was taken by the researcher, and on the other days, it was recorded in detail by telephone.

**Measure:** 3 day food consumption record

**Time Frame:** 3 days

**Description:** Intraoral examination of all children in the study group was performed by sitting on a chair by the window and using a mirror-probe in daylight. Intraoral examination of all children was performed by a single pediatric dentist (E.D.) and recorded in the patient information form. The total number of decayed, missing and filled teeth (Decayed, Missing, And Filled Teeth: DMFT) and tooth surfaces (Decayed, Missing, And Filled Surfaces: DMFS) were calculated.

**Measure:** Oral Examination

**Time Frame:** Within 15 minutes during the meeting with the participant

**Description:** It is a 24-question survey that evaluates sleep quality and disorders by scoring them over a one-month period.

**Measure:** Pittsburg sleep quality index

**Time Frame:** Within 10 minutes during the meeting with the participant

**Description:** It is a 15-question survey developed to be used to determine hedonic hunger in school-age children.

**Measure:** Children's Power of Food Scale

**Time Frame:** Within 10 minutes during the meeting with the participant

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 14-16 years old
* Not receiving special medical nutrition therapy
* No chronic systemic disease, nutritional disorder and/or endocrine disease that may affect growth and development
* Adolescents without congenital developmental disorders

Exclusion Criteria:

* Those who had any severe oral disease or periodontal treatment including supragingival curettage and root planning before the study
* Those who used any antibiotic, anti-inflammatory or sedative medication until 3 months before the study
* Those with bleeding gums on the working day or within the previous 4 weeks
* Those who smoke

**Healthy Volunteers:** True

**Maximum Age:** 16 Years

**Minimum Age:** 14 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**Study Population:** The study included 40 adolescents aged 14-16, who were thin, healthy, slightly overweight and obese, who applied to İsmet Yılmaz Akansu Family Health Center and met the inclusion criteria.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kayseri

**Country:** Turkey

**Facility:** Erciyes University

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Microbial Colonization

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Microbial Colonization

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

### Misc Info Module

- Version Holder: 2024-05-31
