Farmacologia

Trials

BioMed Central

Study protocol

Open Access

Periodontal treatment to improve glycaemic control in diabetic
patients: study protocol of the randomized, controlled DIAPERIO
trial
Jean-Noel Vergnes*1, Elise Arrivé2, Pierre Gourdy3, Hélène Hanaire3,
Vincent Rigalleau4, Henri Gin4, Cyril Sédarat2, Georges Dorignac2,
Christophe Bou2, Michel Sixou1 and Cathy Nabet1
Address:1Department of Dentistry, Toulouse University Hospital (CHU de Toulouse) and Toulouse Dental School, Paul Sabatier University,
Toulouse, France, 2Department of Dentistry and Oral health, Bordeaux Teaching Hospital Department of Odontology, Bordeaux 2 University,
France, 3Diabetology Department, Cardiovascular and Metabolic Unit, Rangueil University Hospital, Toulouse, France and 4Department ofNutrition and Diabetology, Bordeaux Teaching Hospital, Bordeaux 2 University, France
Email: Jean-Noel Vergnes* - vergnes.jn@chu-toulouse.fr; Elise Arrivé - elise.arrive@u-bordeaux2.fr; Pierre Gourdy - pierre.gourdy@inserm.fr;
Hélène Hanaire - hanaire.h@chu-toulouse.fr; Vincent Rigalleau - vincent.rigalleau@chu-bordeaux.fr; Henri Gin - henri.gin@chu-bordeaux.fr;
Cyril Sédarat -cyril.sedarat@u-bordeaux2.fr; Georges Dorignac - georges.dorignac@u-bordeaux2.fr; Christophe Bou - christophe.bou@ubordeaux2.fr; Michel Sixou - sixou@cict.fr; Cathy Nabet - nabet@cict.fr
* Corresponding author

Published: 2 August 2009
Trials 2009, 10:65

doi:10.1186/1745-6215-10-65

Received: 30 June 2009
Accepted: 2 August 2009

This article is available from: http://www.trialsjournal.com/content/10/1/65
©2009 Vergnes et al; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0),
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract
Background: Periodontitis is a common, chronic inflammatorydisease caused by gram-negative bacteria
leading to destruction of tissues supporting the teeth. Epidemiological studies have consistently shown
increased frequency, extent and severity of periodontitis among diabetic adults. More recently, some
controlled clinical trials have also suggested that periodontal treatment could improve glycaemic control
in diabetic patients. However current evidencedoes not provide sufficient information on which to
confidently base any clinical recommendations. The main objective of this clinical trial is to assess whether
periodontal treatment could lead to a decrease in glycated haemoglobin levels in metabolically unbalanced
diabetic patients suffering from chronic periodontitis.
Methods: The DIAPERIO trial is an open-label, 13-week follow-up,randomized, controlled trial. The total
target sample size is planned at 150 participants, with a balanced (1:1) treatment allocation (immediate
treatment vs delayed treatment). Periodontal treatment will include full mouth non-surgical scaling and
root planing, systemic antibiotherapy, local antiseptics (chlorhexidine 0.12%) and oral health instructions.
The primary outcome will be the differencein change of HbA1c between the two groups after the 13weeks' follow-up. Secondary outcomes will be the difference in change of fructosamine levels and quality
of life between the two groups.
Discussion: The DIAPERIO trial will provide insight into the question of whether periodontal treatment
could lead to an improvement in glycaemic control in metabolically unbalanced diabetic patientssuffering
from periodontitis. The results of this trial will help to provide evidence-based recommendations for
clinicians and a draft framework for designing national health policies.
Trial registration: Current Controlled Trials ISRCTN15334496

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Trials 2009, 10:65

Background
Periodontitis is a common, chronic inflammatory disease
caused...