Oral Health in Children With Inflammatory Bowel DiseaseNCT05538923
Oral Health in Children With Inflammatory Bowel Disease
An observational study of Oral Health in Children With Inflammatory Bowel Disease, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health in Children With Inflammatory Bowel Disease
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 15 Jun 2022
- 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: Study population with inflammatory bowel disease in the remission period.
Who may be able to join
- 11-18 years of age
- Study population with IBD in the remission period of disease
- Permanent dentition stage
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- No intervention was given to the patients
- Keywords
- inflammatory bowel disease, children, permanent dentition, nutritional habits
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention was given to the patientsOther
This study was an observational epidemiological study.
| Study group | Role | What they receive |
|---|---|---|
| Patients with IBD | Patients with inflammatory bowel disease on remission period Receives: Other: No intervention was given to the patients | |
| Control | Age- and gender- matched healthy population Receives: Other: No intervention was given to the patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental caries
In the present study WHO criteria were used to detect DMFT (decayed, missing and filled permanent teeth) scores
Measured: In one year
Dental erosion
Dental erosion status was determined with the basic erosive wear examination (BEWE) index
Measured: In one year
Periodontal disease
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.
Measured: In one year
Oral extraintestinal manifestations (EIMs)
including the lip mucosa, buccal mucosa, gingiva; the palatal mucosa and oropharynx; the tongue dorsum, tongue ventrum, and floor of the mouth
Measured: In one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Jun 2021
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Health in Children With Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe 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
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538923
- Sponsor's protocol ID
- HDireskeneli
- Status last verified
- Sep 2022
- First submitted
- 11 Sep 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Caries, Dental Erosion and Periodontal Disease in Children With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT05538923
- Acronym / sponsor ID
- HDireskeneli
- Keywords
- inflammatory bowel disease, children, permanent dentition, nutritional habits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 14 Sep 2022 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with IBD | – | Other: No intervention was given to the patientsPatients with inflammatory bowel disease on remission period |
| Control | – | Other: No intervention was given to the patientsAge- and gender- matched healthy population |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Study population with inflammatory bowel disease in the remission period.
Key inclusion criteria (3 listed)
- 11-18 years of age
- Study population with IBD in the remission period of disease
- Permanent dentition stage
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| No intervention was given to the patientsThis study was an observational epidemiological study. | Other | Control, Patients with IBD |
Primary outcome
Dental caries
Time frame: In one year
In the present study WHO criteria were used to detect DMFT (decayed, missing and filled permanent teeth) scores
Dental erosion
Time frame: In one year
Dental erosion status was determined with the basic erosive wear examination (BEWE) index
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.
Oral extraintestinal manifestations (EIMs)
Time frame: In one year
including the lip mucosa, buccal mucosa, gingiva; the palatal mucosa and oropharynx; the tongue dorsum, tongue ventrum, and floor of the mouth
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 14 Sep 2022.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Health in Children With Inflammatory Bowel Disease, run by Marmara University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Dental caries (time frame: In one year). The study lists 4 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 14 Sep 2022.