Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05146557 |
Other study ID # |
670201423056 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 1, 2015 |
Est. completion date |
October 25, 2015 |
Study information
Verified date |
December 2021 |
Source |
University Ghent |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
Participants and ethical aspects For this case-control study, a total of 162 adolescents
residing in Belgium were examined between July 2015 and October 2015.
Height and weight were measured to calculate the Body Mass Index (BMI) of the participants.
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). Only the
participants with obesity were included in the case group (having a BMI above the 97th
percentile + 2.17 to+2.18 SDS), whereas only the participants with normal weight were
included in the control group (BMI between the 10th and 90th percentile -1.64 to +1.64 SDS).
Clinical examination Anthropometrical and dental examinations were performed in the
educational institutions. Before scoring, dental surfaces were dried using sterile gauze.
Standard illumination (LED head lamps), sterile number five mouth mirrors and CPI periodontal
probes (WHO 1997) were used. 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). According to this index, every permanent tooth surface is evaluated and is
classified into a 4 score criteria, "0" being an indication for the absence of ETW, "1" being
initial loss of surface texture, "2"* being distinct defect, hard tissue loss affecting less
than 50% of tooth surface and "3"* being an indication for hard tissue loss and presence of
ETW in more than the 50% of the surface (*usually involving dentin). The final BEWE sum score
was the result of the sum of the highest score recorded per sextant .
Reproducibility Two paediatric dentists (FM and SD) were educated, instructed and calibrated
for DMFT index. The examiners scored twice several clinical cases in two sessions separated
by a two-week period. Then, the examiners scores were compared against an experienced
benchmark (LM).
Questionnaire A validated questionnaire was applied in order to assess oral hygiene and
dietary habits. Prior to initiation of the study, a content validation of the questionnaire
was performed by five professors with experience in epidemiology. For the reliability of the
questionnaire, a group of 20 students (15-year-old) were asked to complete the questionnaire
twice separated by a two-week period. Once validated, 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.