Full-mouth and Partial-mouth Scaling and Root Planing in Type 2 Diabetic Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Full-mouth and Partial-mouth Scaling and Root Planing in Type 2 Diabetic Subjects: Clinical, Immunological and Microbiological Outcomes

Conditions
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Periodontitis, Diabetes

Intervention / Treatment
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* Procedure: FMSRP
* Drug: Chlorhexidine
* Procedure: PMSRP
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMSRP+CLX<br>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 | Procedure: FMSRP<br>* FMSRP in a maximum of 24 hours.<br>Drug: Chlorhexidine<br>* Application and irrigation of chlorhexidine, rinsing chlorhexidine solution during 60 days<br>* Other names: (N/A);|
| Placebo Comparator: FMSRP + placebo group<br>Full-mouth scaling and root planing in a maximum of 24 hours, application and irrigation of placebo, rinsing placebo solution during 60 days | Procedure: FMSRP<br>* FMSRP in a maximum of 24 hours.<br>Other: Placebo<br>* Application and irrigation of placebo, rinsing placebo solution during 60 days<br>|
| Active Comparator: PMSRP group<br>Partial-mouth scaling and root planing in 4-6 sessions in a maximum of 2 weeks | Procedure: PMSRP<br>* Scaling and root planing in 4-6 sessions in a maximum of 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in clinical attachment level (CAL) in sites with initial PD ≥7mm from baseline to 12 months. |  | From baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in percentage of sites with probing depth ≥5mm |  | From baseline to 12 months | 
| Changes in serum levels of glycemic hemoglobin |  | From baseline to 12 months | 
| Changes in the counts of pathogenic bacterial species |  | From baseline to 12 months | 
| Changes in the levels of tumor necrosis factor-α in gingival crevicular fluid |  | From baseline to 12 months | 
| Changes in the levels of plaque accumulation |  | From baseline to 12 months | 
| Changes in the mean percentage of sites with bleeding on probing |  | From baseline to 12 months | 
| Changes in the full-mouth probing depth |  | From baseline to 12 months | 
| Changes in the serum levels of fasting plasma glucose |  | From baseline to 12 months | 
| Changes in the proportions of pathogenic bacterial species |  | From baseline to 12 months | 
| Changes in the levels of interferon (IFN)-γ in gingival crevicular fluid |  | From baseline to 12 months | 
| Changes in the levels of interleukin (IL)-17 in gingival crevicular fluid |  | From baseline to 12 months | 
| Changes in the levels of IL-23 in gingival crevicular fluid |  | From baseline to 12 months | 
| Changes in the levels of IL-4 in gingival crevicular fluid |  | From baseline to 12 months | 
| Changes in levels of receptor activator of NF-κß ligand (RANKL) in gingival crevicular fluid |  | From baseline to 12 months | 
| Changes in the levels of osteoprotegerin (OPG) in gingival crevicular fluid |  | From baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Chronic Periodontitis, Root Planing, Cytokines, microbiology, Glycated hemoglobin, diabetic subjects