Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/03/2009
Date assigned
30/04/2009
Last edited
21/09/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jean-Noel Vergnes

ORCID ID

Contact details

CHU de Toulouse
Faculté de Chirurgie Dentaire de Toulouse
3
chemin des maraîchers
31400 Toulouse
Toulouse
31400
France
vergnes.jn@chu-toulouse.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PHRC 0803108

Study information

Scientific title

Periodontal treatment for improving glycaemic control in diabetic patients: a randomised controlled trial

Acronym

DIAPERIO

Study hypothesis

Periodontal 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

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

Study design

Randomised single-blind two-centre controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Diabetes mellitus, periodontal disease

Intervention

Periodontal 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Difference between 3-month and baseline HbA1c levels.

Secondary outcome measures

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)

Overall trial start date

01/05/2009

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. 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

Recruitment start date

01/05/2009

Recruitment end date

31/12/2010

Locations

Countries of recruitment

France

Trial participating centre

CHU de Toulouse
Toulouse
31400
France

Sponsor information

Organisation

University Hospital of Toulouse (CHU de Toulouse) (France)

Sponsor details

Direction de la Recherche et de l’Innovation
Hôtel Dieu
2 Rue Viguerie
Cedex 9
Toulouse
31059
France
algans.n@chu-toulouse.fr

Sponsor type

Hospital/treatment centre

Website

http://www.chu-toulouse.fr/

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital of Toulouse (CHU Toulouse) (France) - Hospital Clinical Research Programme (Programme Hospitalier de Recherche Clinique [PHRC], inter-régional 0803108)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19646281

Publication citations

  1. Results

    Vergnes JN, Arrivé E, Gourdy P, Hanaire H, Rigalleau V, Gin H, Sédarat 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, 10, 65, doi: 10.1186/1745-6215-10-65.

Additional files

Editorial Notes