ObesityNCT05146557
Associations Between Obesity, Dental Caries, Erosive Tooth Wear and Periodontal Disease in Adolescents: A Case Control-study
An observational study of Obesity and Obesity, Childhood, run by University Ghent.
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. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Obesity, Childhood, Tooth Wear
- What is being tested?
- Dental examination
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 25 Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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).
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
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.
Read the detailed 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.
- Conditions
- Obesity, Obesity, Childhood, Tooth Wear, Tooth Erosion, Dental Caries, Dental Plaque
- Being tested
- Dental examination
- Keywords
- Tooth wear
- Medical subject headings
- Obesity, Pediatric Obesity, Tooth Wear, Tooth Erosion, Dental Caries, Dental Plaque, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental examinationOther
In this cross sectional observational study only Dental examination and a self response survey was applied.
| Study group | Role | What they receive |
|---|---|---|
| Group Obese adolescents | BMI above the 97th percentile + 2.17 to+2.18 SDS Receives: Other: Dental examination | |
| Group Normal weight adolescents | BMI between the 10th and 90th percentile -1.64 to +1.64 SDS Receives: Other: Dental examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Once on the same day of dental examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Jul 2015
- Primary completion25 Oct 2015
- Study completion25 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146557
- Sponsor's protocol ID
- 670201423056
- Status last verified
- Dec 2021
- First submitted
- 9 Dec 2019
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Obesity, Dental Caries, Erosive Tooth Wear and Periodontal Disease in Adolescents: A Case Control-study
- ClinicalTrials.gov ID
- NCT05146557
- Acronym / sponsor ID
- 670201423056
- Conditions
- Obesity, Obesity, Childhood, Tooth Wear, Tooth Erosion, Dental Caries, Dental Plaque
- Keywords
- Tooth wear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 25 Oct 2015 (actual)
- Study completion
- 25 Oct 2015 (actual)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Obese adolescents | – | Other: Dental examinationBMI above the 97th percentile + 2.17 to+2.18 SDS |
| Group Normal weight adolescents | – | Other: Dental examinationBMI between the 10th and 90th percentile -1.64 to +1.64 SDS |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (6 listed)
- smoking
- chronic disease
- receive treatment with antibiotics three months prior to the study
- consume medications with side effects on the gums
- wearing orthodontic appliances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental examinationIn this cross sectional observational study only Dental examination and a self response survey was applied. | Other | Group Normal weight adolescents, Group Obese adolescents |
Primary outcome
Oral health status
Time frame: Once on the day of dental examination
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).
Association of oral health status and diet/oral hygiene habits
Time frame: Once on the same day of dental examination
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Obesity, Childhood, run by University Ghent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral health status (time frame: Once on the day of dental examination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.