Full-mouth and Partial-mouth Scaling and Root Planing in Type 2 Diabetic Subjects
Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
Summary
The aim of this study will be to evaluate: 1- the effect of full-mouth (FM) scaling and root
(SRP) planing in 24 hours associated with or without extensive application of chlorhexidine
(CLX) on clinical, microbiological, glycemic and immunological parameters in diabetic
subjects with chronic periodontitis at 3, 6 and 12 months post-therapy. The hypothesis is
that FMSRP associated with CLX use will provide the best clinical, microbiological, glycemic
and immunological outcomes for the treatment of diabetic subjects with periodontitis. Sixty
diabetic subjects with chronic periodontitis will be divided in the following therapeutic
groups (n=20 subjects per group): FMSRP+CLX group - FMSRP in a maximum of 24 hours,
application and irrigation of chlorhexidine 2% gel, rinsing chlorhexidine 0.12% solution
during 60 days; FMSRP + placebo group - FMSRP in a maximum of 24 hours, application and
irrigation of placebo, rinsing placebo solution during 60 days; Partial-mouth (PM) SRP group:
SRP in 4-6 sessions in a maximum of 2 weeks. The following clinical parameters will be
evaluated at 3, 6 and 12 months post-therapy: plaque accumulation, gingival bleeding, probing
depth, clinical attachment level, bleeding on probing and suppuration. At these same periods,
glycated hemoglobin levels will be obtained from all subjects. In addition, six subgingival
biofilm samples per subject will be analyzed by checkerboard DNA-DNA hybridization for 40
bacterial species at baseline, 3, 6 and 12 post-therapy. Finally, gingival crevicular fluid
samples from two shallow and two deep sites will be evaluated for the levels of
cyto/chemokines by ELISA. Data will be submitted to appropriate statistical analysis.