DiabetesDIAPERIONCT02563457
Efficacy of Periodontal Treatment on Glycaemic Control in Diabetic Patients
A study testing periodontal manual treatment and no periodontal manual treatment in people with Diabetes, run by University Hospital, Toulouse at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes
- What is being tested?
- periodontal manual treatment and no periodontal manual treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2009to Aug 2015
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient suffering from a periodontitis
- patient with : 7,0% < Hemoglobin A1c < 9,5%
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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.
- Conditions
- Diabetes
- Being tested
- periodontal manual treatment, no periodontal manual treatment
- Keywords
- diabetic patients, periodontal treatment, glycaemic control
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal manual treatmentOther
periodontal manual treatment
no periodontal manual treatmentOther
blood sampling
| Study group | Role | What they receive |
|---|---|---|
| case | Experimental | diabetic patients who will receive periodontal treatment blood sampling Receives: Other: periodontal manual treatment |
| control | Experimental | diabetic patients without periodontal treatment (no periodontal treatment) blood sampling Receives: Other: no periodontal manual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c blood level
efficacy of periodontal treatment on hemoglobin A1c
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startFeb 2009
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Sixou, MD, Principal investigator, UH Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563457
- Sponsor's protocol ID
- 08 031 08
- Acronym
- DIAPERIO
- Status last verified
- Nov 2018
- First submitted
- 23 Jun 2015
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 30136741Vergnes 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.
PubMed 19646281
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Periodontal Treatment on Glycaemic Control in Diabetic Patients
- ClinicalTrials.gov ID
- NCT02563457
- Acronym / sponsor ID
- DIAPERIO / 08 031 08
- Conditions
- Diabetes
- Keywords
- diabetic patients, periodontal treatment, glycaemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 Sep 2015 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | Experimental | Other: periodontal manual treatmentdiabetic patients who will receive periodontal treatment blood sampling |
| control | Experimental | Other: no periodontal manual treatmentdiabetic patients without periodontal treatment (no periodontal treatment) blood sampling |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patient suffering from a periodontitis
- patient with : 7,0% < Hemoglobin A1c < 9,5%
Key exclusion criteria (6 listed)
- 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
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 manual treatmentperiodontal manual treatment | Other | case |
| no periodontal manual treatmentblood sampling | Other | control |
Primary outcome
Hemoglobin A1c blood level
Time frame: 3 months
efficacy of periodontal treatment on hemoglobin A1c
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 15 Dec 2025.
- Results publication: PubMed 30136741Vergnes 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.
- Results publication: PubMed 19646281Vergnes 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.
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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.
Michel Sixou, MD principal investigator
UH Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing periodontal manual treatment and no periodontal manual treatment in people with Diabetes, run by University Hospital, Toulouse at 2 sites 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 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 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Hemoglobin A1c blood level (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02563457, which also lists 2 linked publications.
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 15 Dec 2025.