Title
Full-mouth and Partial-mouth Scaling and Root Planing in Type 2 Diabetic Subjects
Full-mouth and Partial-mouth Scaling and Root Planing in Type 2 Diabetic Subjects: Clinical, Immunological and Microbiological Outcomes
Phase
Phase 4Lead Sponsor
University of Guarulhos (UNG)Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Diabetes PeriodontitisIntervention/Treatment
chlorhexidine ...Study Participants
60The 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.
FMSRP in a maximum of 24 hours.
Application and irrigation of chlorhexidine, rinsing chlorhexidine solution during 60 days
Scaling and root planing in 4-6 sessions in a maximum of 2 weeks
Application and irrigation of placebo, rinsing placebo solution during 60 days
Full-mouth scaling and root planing in a maximum of 24 hours, application and irrigation of chlorhexidine 2% gel, rinsing chlorhexidine 0.12% solution during 60 days
Full-mouth scaling and root planing in a maximum of 24 hours, application and irrigation of placebo, rinsing placebo solution during 60 days
Partial-mouth scaling and root planing in 4-6 sessions in a maximum of 2 weeks
Inclusion Criteria: Clinical diagnosis of type 2 diabetes mellitus Clinical diagnosis of generalized chronic periodontitis > 30 years old At least 15 teeth excluding third molars and teeth indicated to exodontia More than 30% of the sites with probing depth and clinical attachment level ≥ 4 mm at baseline Exclusion Criteria: Pregnancy Lactation Current smoking Smoking within the past 5 years Periodontal or/and antibiotic therapies in the previous 6 months Regular use of mouthrinses containing antimicrobials in the preceding 2 months Other systemic condition that could affect the progression of periodontal disease Long-term use of anti-inflammatory and immunosuppressive medications Presence of periapical pathology Use of orthodontic appliances Multiple systemic complications of DM.
