- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06425328
Effect of Nutritional Habits on Oral Microbiota in Adolescents
May 31, 2024 updated by: Betül Cicek, TC Erciyes University
The aim of this study is to examine the relationship between oral microbiota and eating habits, sleep quality and hedonic hunger in adolescents.
Study Overview
Status
Completed
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.
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kayseri, Turkey
- Erciyes University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Underweight
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.
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Normal weight
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.
|
Overweight
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
|
Obese
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oral microbiome characteristics
Time Frame: 1 month
|
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.
DNA purification from saliva samples was carried out using standard commercial methods.
In the polymerase chain reaction-based amplification of bacterial 16S rRNA sequences, primers belonging to the V3-V4 region, which were previously defined and stated to be suitable for the detection of bacterial diversity, were used.
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1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anthropometric Measurements
Time Frame: 1 month
|
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.
|
1 month
|
3 day food consumption record
Time Frame: 1 month
|
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.
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1 month
|
Oral Examination
Time Frame: 1 month
|
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.
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1 month
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Pittsburg sleep quality index
Time Frame: 1 month
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It is a 19-question survey that evaluates sleep quality and disorders by scoring them over a one-month period.
The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).
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1 month
|
Children's Power of Food Scale
Time Frame: 1 month
|
It is a 15-question survey developed to be used to determine hedonic hunger in school-age children.
Items are rated on a 5-point Likert scale and summed to create a total score.
Higher scores reflect greater responsiveness to the food environment.
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1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 14, 2023
Primary Completion (Actual)
November 17, 2023
Study Completion (Actual)
November 17, 2023
Study Registration Dates
First Submitted
May 17, 2024
First Submitted That Met QC Criteria
May 17, 2024
First Posted (Actual)
May 22, 2024
Study Record Updates
Last Update Posted (Actual)
June 3, 2024
Last Update Submitted That Met QC Criteria
May 31, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ErciyesU-BVD-BAG-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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