Periodontal treatment for improving glycaemic control in diabetic patients

ISRCTN ISRCTN15334496
DOI https://doi.org/10.1186/ISRCTN15334496
Protocol serial number PHRC 0803108
Sponsor University Hospital of Toulouse (CHU de Toulouse) (France)
Funder University Hospital of Toulouse (CHU Toulouse) (France) - Hospital Clinical Research Programme (Programme Hospitalier de Recherche Clinique [PHRC], inter-régional 0803108)
Submission date
12/03/2009
Registration date
30/04/2009
Last edited
30/10/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jean-Noel Vergnes
Scientific

CHU de Toulouse
Faculté de Chirurgie Dentaire de Toulouse
3, chemin des maraîchers
31400 Toulouse
Toulouse
31400
France

vergnes.jn@chu-toulouse.fr

Study information

Primary study designInterventional
Study designRandomised single-blind two-centre controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titlePeriodontal treatment for improving glycaemic control in diabetic patients: a randomised controlled trial
Study acronymDIAPERIO
Study objectivesPeriodontal treatment could lead to an improvement in HbA1c levels in metabolically unbalanced diabetic patients suffering from periodontitis.

We will therefore test the null hypothesis that periodontal treatment does not reduce the HbA1c level in metabolically unbalanced diabetic patients suffering from periodontitis.

Secondary objectives of this study are to assess among metabolically unbalanced diabetic patients suffering from periodontitis:
1. Whether periodontal treatment could lead to an improvement in fructosamin levels
2. Whether periodontal treatment could lead to an improvement in life quality
3. Whether periodontal treatment is safe and effective
Ethics approval(s)1. Committee for Protection of Research Subjects (Comité de Protection des Personnes [CPP]), Sud-Ouest Outre-Mer I, approved on 23/02/2009
2. Sanitary Safety in Health Products Agency (Agence française de sécurité sanitaire des produits de santé [AFSSAPS]), approved on 12/02/2009 (ref: 2008-A01467-48)
3. Advisory Committee for Data Processing in Health Research (Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé [CCTIRS]), approved on 15/01/2009
Health condition(s) or problem(s) studiedDiabetes mellitus, periodontal disease
InterventionPeriodontal treatment will include non-surgical scaling and root planing, systemic antibiotherapy, oral health instructions and antiseptic prescription. It will be performed within 10 days after inclusion for the treatment group, and after 100 days after inclusion for the control group.
Intervention typeOther
Primary outcome measure(s)

Difference between 3-month and baseline HbA1c levels.

Key secondary outcome measure(s)

Difference between 3-month and baseline values of the following:
1. Fructosamin levels
2. Quality of life (SF-36® Health Survey)
3. Adverse clinical outcome event
4. Periodontal Inflamed Surface Area (PISA)

Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration150
Total final enrolment91
Key inclusion criteria1. Male or female, aged >= 18 year old
2. Diabetes mellitus (type I or II), diagnosed since at least one year
3. HbA1c levels comprised between 7.0 and 9.5%
4. No change in diabetic medication 3 months before inclusion
5. Periodontal disease (at least one site on at least 4 teeth with Probing Pocket Depth >= 4 mm AND Clinical Attachment Loss >= 3 mm)
6. At least 6 remaining teeth
7. Subject able to understand and willing to provide written informed consent in French
8. Subject affiliated to the security system
Key exclusion criteria1. Receiving antibiotherapy or chronic steroid therapy
2. Presence of significant renal disease, as indicated by creatinine clearance less than 60 ml/min
3. Have another medical condition likely to cause hospitalisation within 4 months
4. Presence of serious or unstable infectious disease, hepatic disease, phenylcetonuria
5. Subject at risk of endocarditis
6. Pacemaker
7. Antithrombotic treatment
8. History of allergy to amoxicillin and clindamycin
9. Pregnant, lactating, or plans to become pregnant during the study
10. Participation in another study with an investigational compound
Date of first enrolment01/05/2009
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • France

Study participating centre

CHU de Toulouse
Toulouse
31400
France

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 02/08/2009 Yes No
Results article results 01/10/2018 30/10/2019 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

30/10/2019: Publication reference and total final enrolment number added.

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