NCT06283602

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2021

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

February 15, 2024

Last Update Submit

February 22, 2024

Conditions

Keywords

dental cariesperiodontal healthchildrenobesityerosive tooth wear

Outcome Measures

Primary Outcomes (3)

  • the results of DMFT, plaque and gingival indies

    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

    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

    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 Outcomes (2)

  • biochemical parameters of obese individuals

    11 months

  • other biochemical parameters of obese individuals

    up to 11 months

Study Arms (1)

Kahramanmaraş Sütçü İmam University

OTHER

Patient who apply to our clinic for routine paediatric treatment for the included in the study

Diagnostic Test: oral health status

Interventions

oral health statusDIAGNOSTIC_TEST

the dentists examined the dried teeth with a probe and mount mirror in a dental unit.

Kahramanmaraş Sütçü İmam University

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years healthy children and adolescents

You may not qualify if:

  • Infection,
  • diabetes, leukemia, asthma, bronchitis, cognitive neuromotor disorder, hormonal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aslı Soğukpınar Önsüren

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pediatric ObesityDental CariesObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsTooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 15, 2024

First Posted

February 28, 2024

Study Start

January 1, 2020

Primary Completion

March 5, 2021

Study Completion

April 29, 2021

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations