- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06283602
Oral Health in Children and Adolescents With Obesity and Normal Weight
Erosive Tooth Wear, Caries Experience and Periodontal Health in Children and Adolescents With Obesity and Normal Weight
We aimed to compare the oral health status (dmft/DMFT index, IDCAS-II, BEWE, plaque index, gingival index, probing depth) between normal-weight (NW) and obese (OW) children/adolescents.
82 participants aged 6-16 years were concluded in this cross-sectional study. The children/adolescents were classified according to the body mass index (BMI): NW (n=41) and OW (n=41). Caries experience was assessed by the International Caries Detection and Assessment System (ICDAS-II), decay, missing, filling teeth (dmft) for the primary teeth and (DMFT) for the permanent teeth, erosive tooth wear using Basic Erosive Wear Examination (BEWE), Plaque Index (PI) and Gingival Index (GI), Probing Depth (PD).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mersin, Turkey
- Aslı Soğukpınar Önsüren
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria: 6-16 years obesity children and adolescents
- 6-16 years healthy children and adolescents
Exclusion Criteria:
- Infection,
- diabetes, leukemia, asthma, bronchitis, cognitive neuromotor disorder, hormonal disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Kahramanmaraş Sütçü İmam University
Patient who apply to our clinic for routine paediatric treatment for the included in the study
|
the dentists examined the dried teeth with a probe and mount mirror in a dental unit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the results of DMFT, plaque and gingival indies
Time Frame: 12 months
|
The results of the study indicate that individuals with obesity tend to exhibit significantly higher scores for DMFT, plaque, and gingival index as compared to those with normal weight t significantly higher scores for DMFT, plaque, and gingival index as compared to those with normal weight (p<0.05)
|
12 months
|
the results of dmft, BEWE, ICDAS-II, probing dept
Time Frame: up to 12 months
|
No significant difference was observed concerning dmft and other factors (p>0.05)
|
up to 12 months
|
Comparison of demographic attributes between obese and normal weights
Time Frame: 12 months
|
Significant disparities were identified between patients with normal weight and those who were obese, particularly in BMI, income, and tooth brushing habits.
Obese patients exhibited considerably higher BMI scores in comparison to those with normal weight (p<0.001).Body mass index (BMIs; kg/m2) was calculated by the pediatrician using the patients' height (meters) and weight (kilograms).
BMI 5-85th percentile normal weight according to gender and age; BMI 85- 95 percentile overweight; Those at the 95th percentile and above were considered obese
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
biochemical parameters of obese individuals
Time Frame: 11 months
|
Procalcitonin exhibited significantly negative correlation between DMFT and ICDAS-II (p<0.05).
|
11 months
|
other biochemical parameters of obese individuals
Time Frame: up to 11 months
|
No significant correlation was found between the biomarkers and other investigated factors (p>0.05)
|
up to 11 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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