title: Periodontal treatment to improve glycaemic control in diabetic patients: study protocol of the randomized, controlled DIAPERIO trial.
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.
  
  
  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.
authors: Department of Dentistry, Toulouse University Hospital (CHU de Toulouse) and Toulouse Dental School, Paul Sabatier University, Toulouse, France. vergnes.jn@chu-toulouse.fr
authors: Jean-Noel
authors: JN
authors: Vergnes
authors: Elise
authors: E
authors: Arrivé
authors: Pierre
authors: P
authors: Gourdy
authors: Hélène
authors: H
authors: Hanaire
authors: Vincent
authors: V
authors: Rigalleau
authors: Henri
authors: H
authors: Gin
authors: Cyril
authors: C
authors: Sédarat
authors: Georges
authors: G
authors: Dorignac
authors: Christophe
authors: C
authors: Bou
authors: Michel
authors: M
authors: Sixou
authors: Cathy
authors: C
authors: Nabet
mesh_terms: D002908:Chronic Disease; D048909:Diabetes Complications / Q000628:therapy*; D006801:Humans; D006943:Hyperglycemia / Q000628:therapy*; D009910:Oral Hygiene; D010518:Periodontitis / Q000628:therapy*; D012107:Research Design