NCT05146557

Brief Summary

Objectives To compare oral health (dental caries, periodontal status, and erosive tooth wear (ETW)), diet and oral hygiene habits between obese and normal weight adolescents, and to explore possible risk associations. Materials and Methods In this case-control study, a convenient sample of 81 obese adolescents (age range 11-18) from a rehabilitation centre, and 81 age-sex-matched normal weight adolescents were selected. Groups were defined using the Body Mass Index and growth curves for Flemish. Oral health was measured using DMFT, gingival, plaque and BEWE index. A validated questionnaire was utilized to assess diet and oral hygiene habits.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2015

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2019

Completed
2 years until next milestone

First Posted

Study publicly available on registry

December 6, 2021

Completed
Last Updated

December 6, 2021

Status Verified

December 1, 2021

Enrollment Period

4 months

First QC Date

December 9, 2019

Last Update Submit

December 3, 2021

Conditions

Keywords

Tooth wear

Outcome Measures

Primary Outcomes (2)

  • Oral health status

    Caries experience was screened using DMFT index (Decayed, Missing, Filled Teeth) with a subdivision for D1 (early caries, 'white spots'), D2 (enamel caries) or D3 (dentine caries). The periodontal status was evaluated by measuring the Gingivitis index (Silness and Loë, 1963), Plaque index (Silness and Loë, 1964) and the presence of periodontal pockets (≥4mm) in all Ramfjord teeth (1.6, 2.1, 2.4, 3.6, 4.1 and 4.4). Data were obtained from the neighbouring tooth in cases where one of these teeth were not present. Deciduous teeth and teeth with developmental disturbances were excluded. Regarding ETW, prevalence and severity was recorded using the Basic Erosive Wear Examination (BEWE index).

    Once on the day of dental examination

  • Association of oral health status and diet/oral hygiene habits

    A validated questionnaire was applied in order to assess oral hygiene and dietary habits. The questionnaire was applied to each participant of the study on the same day of dental examination. Participants were asked to answer the questionnaire according to their habits just before they enter the rehabilitation centre.

    Once on the same day of dental examination

Study Arms (2)

Group Obese adolescents

BMI above the 97th percentile + 2.17 to+2.18 SDS

Other: Dental examination

Group Normal weight adolescents

BMI between the 10th and 90th percentile -1.64 to +1.64 SDS

Other: Dental examination

Interventions

In this cross sectional observational study only Dental examination and a self response survey was applied.

Group Normal weight adolescentsGroup Obese adolescents

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Cases were all the obese children/adolescents (N=81; age range 11 to 18 years-old) who were recently participating in a treatment program for obese patients in a rehabilitation centre for chronic diseases (Zee Preventorium, De Haan, Belgium). Based on the number of cases, 81 normal weight students of two Belgian secondary schools (Deinze, Belgium) were recruited as controls. Controls were sex-age-matched, had the same education level and socioeconomic status (SES).

You may qualify if:

  • obesity in case group (having a BMI above the 97th percentile + 2.17 to+2.18 SDS),
  • normal weight in the control group (BMI between the 10th and 90th percentile -1.64 to +1.64 SDS). Obese and normal weight groups were defined using the BMI according to the European Childhood Obesity Group (ECOG) and the growth curves for Flemish boys and girls (2-20years).

You may not qualify if:

  • smoking
  • chronic disease
  • receive treatment with antibiotics three months prior to the study
  • consume medications with side effects on the gums
  • wearing orthodontic appliances
  • other ethnicity (not Belgian) were excluded as ethnicity is an influential factor in the relation between caries and obesity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityPediatric ObesityTooth WearTooth ErosionDental CariesDental PlaqueGingivitis

Interventions

Diagnosis, Oral

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsTooth DiseasesStomatognathic DiseasesTooth DemineralizationDental DepositsInfectionsGingival DiseasesPeriodontal DiseasesMouth Diseases

Intervention Hierarchy (Ancestors)

Dentistry

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2019

First Posted

December 6, 2021

Study Start

July 1, 2015

Primary Completion

October 25, 2015

Study Completion

October 25, 2015

Last Updated

December 6, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share