Clinical trial NCT02062047: Full-mouth and Partial-mouth Scaling and Root Planing in Type 2 Diabetic Subjects
Official title: Full-mouth and Partial-mouth Scaling and Root Planing in Type 2 Diabetic Subjects: Clinical, Immunological and Microbiological Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontitis
Diabetes
Keywords: Diabetes Mellitus
Chronic Periodontitis
Root Planing
Cytokines
microbiology
Glycated hemoglobin
diabetic subjects
Lead sponsor: University of Guarulhos
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in clinical attachment level (CAL) in sites with initial PD ≥7mm from baseline to 12 months.
timeFrame: From baseline to 12 months
Secondary outcomes:
measure: Changes in percentage of sites with probing depth ≥5mm
timeFrame: From baseline to 12 months
measure: Changes in serum levels of glycemic hemoglobin
timeFrame: From baseline to 12 months
measure: Changes in the counts of pathogenic bacterial species
timeFrame: From baseline to 12 months
measure: Changes in the levels of tumor necrosis factor-α in gingival crevicular fluid
timeFrame: From baseline to 12 months
measure: Changes in the levels of plaque accumulation
timeFrame: From baseline to 12 months
measure: Changes in the mean percentage of sites with bleeding on probing
timeFrame: From baseline to 12 months
measure: Changes in the full-mouth probing depth
timeFrame: From baseline to 12 months
measure: Changes in the serum levels of fasting plasma glucose
timeFrame: From baseline to 12 months
measure: Changes in the proportions of pathogenic bacterial species
timeFrame: From baseline to 12 months
measure: Changes in the levels of interferon (IFN)-γ in gingival crevicular fluid
timeFrame: From baseline to 12 months
measure: Changes in the levels of interleukin (IL)-17 in gingival crevicular fluid
timeFrame: From baseline to 12 months
measure: Changes in the levels of IL-23 in gingival crevicular fluid
timeFrame: From baseline to 12 months
measure: Changes in the levels of IL-4 in gingival crevicular fluid
timeFrame: From baseline to 12 months
measure: Changes in levels of receptor activator of NF-κß ligand (RANKL) in gingival crevicular fluid
timeFrame: From baseline to 12 months
measure: Changes in the levels of osteoprotegerin (OPG) in gingival crevicular fluid
timeFrame: From baseline to 12 months
Other outcomes:
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