- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02563457
Efficacy of Periodontal Treatment on Glycaemic Control in Diabetic Patients (DIAPERIO)
December 5, 2025 updated by: University Hospital, Toulouse
This study will assess the efficacy of periodontal treatment in diabetic patient.
Patients will be randomized in the periodontal group or in the control group.
The control group will received a periodontal treatment after the study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
91
Phase
- Not Applicable
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
-
-
-
Bordeaux, France, 33000
- UH Bordeaux
-
Toulouse, France, 31000
- UHToulouse
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- patient suffering from a periodontitis
- patient with : 7,0% < Hemoglobin A1c < 9,5%
Exclusion Criteria:
- If an hospitalization is planned within the next 4 months
- Patient suffering from chronic infectious pathology (HIV, hepatitis C virus, hepatitis B virus, mononucleosis)
- Renal insufficiency
- Contra indication for amoxicilline or clindamycin
- Antithrombotic treatment
- Liver disease
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: case
diabetic patients who will receive periodontal treatment blood sampling
|
periodontal manual treatment
|
|
Experimental: control
diabetic patients without periodontal treatment (no periodontal treatment) blood sampling
|
blood sampling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hemoglobin A1c blood level
Time Frame: 3 months
|
efficacy of periodontal treatment on hemoglobin A1c
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
fructosamine blood level
Time Frame: 3 weeks
|
Compare the fructosamine content in blood between the 2 groups
|
3 weeks
|
|
Quality of life
Time Frame: 3 months
|
Compare the quality of life between the 2 groups using the 36-Item Short Form Health Survey (SF36)
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michel Sixou, MD, UH Toulouse
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Vergnes JN, Canceill T, Vinel A, Laurencin-Dalicieux S, Maupas-Schwalm F, Blasco-Baque V, Hanaire H, Arrive E, Rigalleau V, Nabet C, Sixou M, Gourdy P, Monsarrat P; DIAPERIO Group. The effects of periodontal treatment on diabetic patients: The DIAPERIO randomized controlled trial. J Clin Periodontol. 2018 Oct;45(10):1150-1163. doi: 10.1111/jcpe.13003. Epub 2018 Sep 14.
- Vergnes JN, Arrive E, Gourdy P, Hanaire H, Rigalleau V, Gin H, Sedarat C, Dorignac G, Bou C, Sixou M, Nabet C. Periodontal treatment to improve glycaemic control in diabetic patients: study protocol of the randomized, controlled DIAPERIO trial. Trials. 2009 Aug 2;10:65. doi: 10.1186/1745-6215-10-65.
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
February 1, 2009
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
June 23, 2015
First Submitted That Met QC Criteria
September 29, 2015
First Posted (Estimated)
September 30, 2015
Study Record Updates
Last Update Posted (Estimated)
December 15, 2025
Last Update Submitted That Met QC Criteria
December 5, 2025
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08 031 08
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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