Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2009 Aug 2:10:65.
doi: 10.1186/1745-6215-10-65.

Periodontal treatment to improve glycaemic control in diabetic patients: study protocol of the randomized, controlled DIAPERIO trial

Jean-Noel Vergnes  1 , Elise Arrivé, Pierre Gourdy, Hélène Hanaire, Vincent Rigalleau, Henri Gin, Cyril Sédarat, Georges Dorignac, Christophe Bou, Michel Sixou, Cathy Nabet
Affiliations
Randomized Controlled Trial

Periodontal treatment to improve glycaemic control in diabetic patients: study protocol of the randomized, controlled DIAPERIO trial

Jean-Noel Vergnes et al. Trials. .

Abstract

Background: Periodontitis is a common, chronic inflammatory disease 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 evidence does 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 difference in change of HbA1c between the two groups after the 13-weeks' 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 patients suffering 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.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Study timelines.
See this image and copyright information in PMC

References

    1. Albandar JM. Epidemiology and risk factors of periodontal diseases. Dent Clin North Am. 2005;49:517–532. doi: 10.1016/j.cden.2005.03.003. - DOI - PubMed
    1. Bourgeois D, Bouchard P, Mattout C. Epidemiology of periodontal status in dentate adults in France, 2002-2003. J Periodontal Res. 2007;42:219–227. doi: 10.1111/j.1600-0765.2006.00936.x. - DOI - PubMed
    1. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004;27:1047–1053. doi: 10.2337/diacare.27.5.1047. - DOI - PubMed
    1. Mealey BL, Oates TW. Diabetes mellitus and periodontal diseases. J Periodontol. 2006;77:1289–1303. doi: 10.1902/jop.2006.050459. - DOI - PubMed
    1. Aldridge JP, Lester V, Watts TL, Collins A, Viberti G, Wilson RF. Single-blind studies of the effects of improved periodontal health on metabolic control in type 1 diabetes mellitus. J Clin Periodontol. 1995;22:271–275. doi: 10.1111/j.1600-051X.1995.tb00147.x. - DOI - PubMed

Publication types

Associated data