NCT02563457

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
Last Updated

December 15, 2025

Status Verified

November 1, 2018

Enrollment Period

6.5 years

First QC Date

June 23, 2015

Last Update Submit

December 5, 2025

Conditions

Keywords

diabetic patientsperiodontal treatmentglycaemic control

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c blood level

    efficacy of periodontal treatment on hemoglobin A1c

    3 months

Other Outcomes (2)

  • fructosamine blood level

    3 weeks

  • Quality of life

    3 months

Study Arms (2)

case

EXPERIMENTAL

diabetic patients who will receive periodontal treatment blood sampling

Other: periodontal manual treatment

control

EXPERIMENTAL

diabetic patients without periodontal treatment (no periodontal treatment) blood sampling

Other: no periodontal manual treatment

Interventions

periodontal manual treatment

case

blood sampling

control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patient suffering from a periodontitis
  • patient with : 7,0% \< Hemoglobin A1c \< 9,5%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UH Bordeaux

Bordeaux, 33000, France

Location

UHToulouse

Toulouse, 31000, France

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Michel Sixou, MD

    UH Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2015

First Posted

September 30, 2015

Study Start

February 1, 2009

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

December 15, 2025

Record last verified: 2018-11

Locations