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


CONCLUSIONS
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.


BACKGROUND
Current Controlled Trials ISRCTN15334496.
Vergnes
Jean-Noel
JN
Department of Dentistry, Toulouse University Hospital (CHU de Toulouse) and Toulouse Dental School, Paul Sabatier University, Toulouse, France. vergnes.jn@chu-toulouse.fr
Arrivé
Elise
E
Gourdy
Pierre
P
Hanaire
Hélène
H
Rigalleau
Vincent
V
Gin
Henri
H
Sédarat
Cyril
C
Dorignac
Georges
G
Bou
Christophe
C
Sixou
Michel
M
Nabet
Cathy
C
D002908:Chronic Disease; D048909:Diabetes Complications / Q000628:therapy*; D006801:Humans; D006943:Hyperglycemia / Q000628:therapy*; D009910:Oral Hygiene; D010518:Periodontitis / Q000628:therapy*; D012107:Research Design