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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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
Changes in clinical attachment level (CAL) in sites with initial PD ≥7mm from baseline to 12 months.
Time frame: From baseline to 12 months
Changes in percentage of sites with probing depth ≥5mm
Time frame: From baseline to 12 months
Changes in serum levels of glycemic hemoglobin
Time frame: From baseline to 12 months
Changes in the counts of pathogenic bacterial species
Time frame: From baseline to 12 months
Changes in the levels of tumor necrosis factor-α in gingival crevicular fluid
Time frame: From baseline to 12 months
Changes in the levels of plaque accumulation
Time frame: From baseline to 12 months
Changes in the mean percentage of sites with bleeding on probing
Time frame: From baseline to 12 months
Changes in the full-mouth probing depth
Time frame: From baseline to 12 months
Changes in the serum levels of fasting plasma glucose
Time frame: From baseline to 12 months
Changes in the proportions of pathogenic bacterial species
Time frame: From baseline to 12 months
Changes in the levels of interferon (IFN)-γ in gingival crevicular fluid
Time frame: From baseline to 12 months
Changes in the levels of interleukin (IL)-17 in gingival crevicular fluid
Time frame: From baseline to 12 months
Changes in the levels of IL-23 in gingival crevicular fluid
Time frame: From baseline to 12 months
Changes in the levels of IL-4 in gingival crevicular fluid
Time frame: From baseline to 12 months
Changes in levels of receptor activator of NF-κß ligand (RANKL) in gingival crevicular fluid
Time frame: From baseline to 12 months
Changes in the levels of osteoprotegerin (OPG) in gingival crevicular fluid
Time frame: From baseline to 12 months
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