NCT02062047

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Guarulhos · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Periodontitis
• Diabetes

Interventions

Type	Name	Description
PROCEDURE	FMSRP	FMSRP in a maximum of 24 hours.
DRUG	Chlorhexidine	Application and irrigation of chlorhexidine, rinsing chlorhexidine solution during 60 days
PROCEDURE	PMSRP	Scaling and root planing in 4-6 sessions in a maximum of 2 weeks
OTHER	Placebo	Application and irrigation of placebo, rinsing placebo solution during 60 days

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-03-01
• Completion: 2010-04-01
• First posted: 2014-02-13
• Last updated: 2014-02-13