Inflammatory Bowel DiseasesMICIMaPNCT04380922
Prevalence of Periodontal Diseases in IBD
An observational study of Inflammatory Bowel Diseases and Periodontal Diseases, run by CHU de Reims at 1 site in France.
Trial summary
Periodontal diseases are highly prevalent inflammatory diseases. It is now well known that they are correlated with numerous systemic diseases as : diabetes, chronic obstructive pulmonary disease, metabolic syndrome or rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Periodontal Diseases
- What is being tested?
- Periodontal screening
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2020to 10 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients consulting for the management of Crohn's disease or Ulcerative colitis
Who may be able to join
- Patients
- consulting Gastroenterology departments in the university hospital of Reims or Amiens-Picardie for the management of Crohn's disease or Ulcerative colitis
- signed informed consent form
- affiliated to the French Social Security system
Who cannot join
- Patients presenting:
- a medical history likely to compromise protocol (psychiatric disorders, other inflammatory diseases, antibiotics, NSAIDs within the last 3 months)
- Diabetes
- Inflammatory rheumatism
- Cancer or radiotherapy up to5 years before inclusion
- X-ray therapy in the area of interest
Show all 9Show fewer
- Pregnancy or Breastfeeding
- Eating disorders
- Patients under legal protection, trusteeship or guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Periodontal Diseases in Inflammatory Bowel Diseases : a Pilot-study
Periodontal diseases are highly prevalent inflammatory diseases. It is now well known that they are correlated with numerous systemic diseases as : diabetes, chronic obstructive pulmonary disease, metabolic syndrome or rheumatoid arthritis. Recently, periodontal diseases have been correlated with inflammatory bowel diseases (IBD). IBD include two types, Crohn's disease and Ulcerative Colitis. It could be a significant risk factor for the pathogenesis of periodontal disease. These diseases present common features : a high prevalence worldwide, multifactorial pathogenies with common mechanisms. To date, no study has linked activity of IBD and periodontal diseases. The authors hypotheses that the prevalence of periodontal diseases could be increased in patient presenting an active IBD
Read the detailed description
The present study explores the prevalence of periodontal diseases regarding to the activity status of IBD (active versus non-active).
Diseases activity will be assessed by HBI (Crohn's disease) or partial Mayo score (Ulcerative Colitis) associated with fecal calprotectin and/or CRP and/or inflammatory/ulcerative lesions.
Periodontal diseases (periodontitis and gingivitis) will be diagnosed according to the international classification of periodontal diseases (Chicago 2017) and based on the decision-making algorithms by Tonetti and Sanz. A periodontal screening, socio-demographic data and clinical data will be collected. Then, oral mucosa dermatological manifestations relative to IBD, treatment need (ICDAS) and quality of life related to oral health (GOHAI) will be evaluated. These data will be collected by a periodontist.
The principal hypothesis of this study is that the prevalence of periodontal diseases could be increased in patient presenting an active IBD.
The primary objective is to evaluate if patients presenting active IBD present more stage III and IV periodontal diseases than non-active IBD ones.
The second objectives are :
- to compare periodontal diseases, gingivitis and oral mucosa dermatological manifestations rates according to the diseases activity, the IBD type and the treatment used to treat IBD,
- to compare oral treatment need according to the activity and the type of IBD,
- to compare quality of life related to oral health according to the activity and the type of IBD
- Conditions
- Inflammatory Bowel Diseases, Periodontal Diseases
- Being tested
- Periodontal screening
- Medical subject headings
- Inflammatory Bowel Diseases, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal screeningOther
Periodontal data collection (PPD, REC, CAL)
| Study group | Role | What they receive |
|---|---|---|
| Active IBD | Active Inflammatory Bowel Diseases defined as :
For Crohn's disease :
* Harvey Bradshaw Index ≥ 4
* Associated with fecal calprotectin rate > 250 µg/g within 3 months OR CRP ≥ 6mg /L OR the presence of ulcerative and/or inflammatory lesions in endoscopy or in imaging within 3 months For Ulcerative colitis
* Partial Mayo score ≥ 2
* Associated with fecal calprotectin rate > 250 µg/g within 3 months OR CRP ≥ 6mg /L OR the presence of ulcerative and/or inflammatory lesions in endoscopy within 3 months Receives: Other: Periodontal screening | |
| Non-active IBD | Non-active Inflammatory Bowel Diseases Receives: Other: Periodontal screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Periodontal Disease
Periodontal Disease will be diagnosed according to the new classification of periodontal diseases (Chicago, 2017) and defined by the decision-making algorithms (Tonetti and Sanz, 2019). Diagnosis will be based on Buccal or lingual Clinical attachment level (CAL), Recession (REC) and Periodontal Pocket Depths (PPD) measurement.
Measured: Day 0
Secondary outcomes (4)
Gingivitis
Gingivitis will be diagnosed according to the new classification of periodontal diseases (Chicago, 2017) and defined by the decision-making algorithms (Tonetti and Sanz, 2019). Bleeding On Probing (BOP) higher than 10% is considered as a Gingivitis
Measured: Day 0
Oral mucosa dermatological manifestations secondary to IBD
Defined by WHO criteria (2013)
Measured: Day 0
Oral Health Quality of Life
GOHAI validated in French for general population -Tubert-Jeanin et al., 2003)
Measured: Day 0
Oral treatment need
Evaluated by ICDAS (International Caries Detection and Assessment Score) (Ismaïl et al., 2007)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start19 Jun 2020
- Primary completion30 Jul 2021
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380922
- Sponsor's protocol ID
- PO20062*
- Acronym
- MICIMaP
- Status last verified
- Jun 2022
- First submitted
- 5 May 2020
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Periodontal Diseases in Inflammatory Bowel Diseases : a Pilot-study
- ClinicalTrials.gov ID
- NCT04380922
- Acronym / sponsor ID
- MICIMaP / PO20062*
- Conditions
- Inflammatory Bowel Diseases, Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 8 May 2020 (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.
Periodontal diseases are highly prevalent inflammatory diseases. It is now well known that they are correlated with numerous systemic diseases as : diabetes, chronic obstructive pulmonary disease, metabolic syndrome or rheumatoid arthritis. Recently, periodontal diseases have been correlated with inflammatory bowel diseases (IBD). IBD include two types, Crohn's disease and Ulcerative Colitis. It could be a significant risk factor for the pathogenesis of periodontal disease. These diseases present common features : a high prevalence worldwide, multifactorial pathogenies with common mechanisms. To date, no study has linked activity of IBD and periodontal diseases. The authors hypotheses that the prevalence of periodontal diseases could be increased in patient presenting an active IBD
Detailed description
The present study explores the prevalence of periodontal diseases regarding to the activity status of IBD (active versus non-active).
Diseases activity will be assessed by HBI (Crohn's disease) or partial Mayo score (Ulcerative Colitis) associated with fecal calprotectin and/or CRP and/or inflammatory/ulcerative lesions.
Periodontal diseases (periodontitis and gingivitis) will be diagnosed according to the international classification of periodontal diseases (Chicago 2017) and based on the decision-making algorithms by Tonetti and Sanz. A periodontal screening, socio-demographic data and clinical data will be collected. Then, oral mucosa dermatological manifestations relative to IBD, treatment need (ICDAS) and quality of life related to oral health (GOHAI) will be evaluated. These data will be collected by a periodontist.
The principal hypothesis of this study is that the prevalence of periodontal diseases could be increased in patient presenting an active IBD.
The primary objective is to evaluate if patients presenting active IBD present more stage III and IV periodontal diseases than non-active IBD ones.
The second objectives are :
- to compare periodontal diseases, gingivitis and oral mucosa dermatological manifestations rates according to the diseases activity, the IBD type and the treatment used to treat IBD,
- to compare oral treatment need according to the activity and the type of IBD,
- to compare quality of life related to oral health according to the activity and the type of IBD
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active IBD | – | Other: Periodontal screeningActive Inflammatory Bowel Diseases defined as : For Crohn's disease : * Harvey Bradshaw Index ≥ 4 * Associated with fecal calprotectin rate > 250 µg/g within 3 months OR CRP ≥ 6mg /L OR the presence of ulcerative and/or inflammatory lesions in endoscopy or in imaging within 3 months For Ulcerative colitis * Partial Mayo score ≥ 2 * Associated with fecal calprotectin rate > 250 µg/g within 3 months OR CRP ≥ 6mg /L OR the presence of ulcerative and/or inflammatory lesions in endoscopy within 3 months |
| Non-active IBD | – | Other: Periodontal screeningNon-active Inflammatory Bowel Diseases |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients consulting for the management of Crohn's disease or Ulcerative colitis
Key inclusion criteria (4 listed)
- Patients
- consulting Gastroenterology departments in the university hospital of Reims or Amiens-Picardie for the management of Crohn's disease or Ulcerative colitis
- signed informed consent form
- affiliated to the French Social Security system
Key exclusion criteria (9 listed)
- a medical history likely to compromise protocol (psychiatric disorders, other inflammatory diseases, antibiotics, NSAIDs within the last 3 months)
- Diabetes
- Inflammatory rheumatism
- Cancer or radiotherapy up to5 years before inclusion
- X-ray therapy in the area of interest
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 |
|---|---|---|
| Periodontal screeningPeriodontal data collection (PPD, REC, CAL) | Other | Active IBD, Non-active IBD |
Primary outcome
Prevalence of Periodontal Disease
Time frame: Day 0
Periodontal Disease will be diagnosed according to the new classification of periodontal diseases (Chicago, 2017) and defined by the decision-making algorithms (Tonetti and Sanz, 2019). Diagnosis will be based on Buccal or lingual Clinical attachment level (CAL), Recession (REC) and Periodontal Pocket Depths (PPD) measurement.
4 secondary outcomes
Gingivitis
Time frame: Day 0
Oral mucosa dermatological manifestations secondary to IBD
Time frame: Day 0
Oral Health Quality of Life
Time frame: Day 0
Oral treatment need
Time frame: Day 0
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 13 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
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 Inflammatory Bowel Diseases and Periodontal Diseases, run by CHU de Reims at 1 site in France.
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 4 inclusion and 9 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 13 Jun 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 France. 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?
Prevalence of Periodontal Disease (time frame: Day 0). 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 13 Jun 2022.