- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05538923
Oral Health in Children With Inflammatory Bowel Disease
September 11, 2022 updated by: Marmara University
Dental Caries, Dental Erosion and Periodontal Disease in Children With Inflammatory Bowel Disease
In adults with inflammatory bowel disease (IBD), a higher prevalence of dental caries and periodontal disease has been reported compared with healthy control subjects, but similar data on children are missing in the literature.We aimed to evaluate the prevalence of dental erosion, dental caries and periodontal disease in children with IBD.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
In this age- and gender-matched prospective case-control study, detailed questionnaires including nutritional habits and oral examinations were completed for 32 IBD patients aged 11 to 18 (15,53±2,00 yr) and 32 healthy controls based on the established criteria of the World Health Organization by the same pediatric dentist.
Study Type
Observational
Enrollment (Actual)
64
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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İstanbul, Turkey
- Marmara University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Study population with inflammatory bowel disease in the remission period.
Description
Inclusion Criteria:
- 11-18 years of age
- Study population with IBD in the remission period of disease
- Permanent dentition stage
Exclusion Criteria:
- Those who refused or whose families refused participation in this study
- Study population with IBD in the active period of disease
- Primary or mix dentition stage
- Systemic conditions, or medications with impact on periodontal tissues and previous orthodontic or periodontal treatment within the last year.
- Smoking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with IBD
Patients with inflammatory bowel disease on remission period
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This study was an observational epidemiological study.
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Control
Age- and gender- matched healthy population
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This study was an observational epidemiological study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dental caries
Time Frame: In one year
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In the present study WHO criteria were used to detect DMFT (decayed, missing and filled permanent teeth) scores
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In one year
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Dental erosion
Time Frame: In one year
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Dental erosion status was determined with the basic erosive wear examination (BEWE) index
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In one year
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Periodontal disease
Time Frame: In one year
|
The patients' and controls' gingival condition was also scored according to the criteria of a Gingival Index (GI) System.
The oral hygiene status was determined with the PCR index in order to assess the presence or absence of marginal plaque.
The prevalence and the severity of periodontal disease were recorded with the CPITN after dividing the oral cavity into sextants.
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In one year
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Oral extraintestinal manifestations (EIMs)
Time Frame: In one year
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including the lip mucosa, buccal mucosa, gingiva; the palatal mucosa and oropharynx; the tongue dorsum, tongue ventrum, and floor of the mouth
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In one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Actual)
June 15, 2022
Study Completion (Actual)
June 15, 2022
Study Registration Dates
First Submitted
September 11, 2022
First Submitted That Met QC Criteria
September 11, 2022
First Posted (Actual)
September 14, 2022
Study Record Updates
Last Update Posted (Actual)
September 14, 2022
Last Update Submitted That Met QC Criteria
September 11, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HDireskeneli
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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