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

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 Overview

• Status: Completed
• Conditions: Diabetes; Periodontitis
• Intervention / Treatment: Procedure: FMSRP; Drug: Chlorhexidine; Other: Placebo; Procedure: PMSRP

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: FMSRP+CLX; 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; FMSRP in a maximum of 24 hours.; Drug: Chlorhexidine; Application and irrigation of chlorhexidine, rinsing chlorhexidine solution during 60 days; Other Names: (N/A)
PLACEBO_COMPARATOR: FMSRP + placebo group; 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; FMSRP in a maximum of 24 hours.; Other: Placebo; Application and irrigation of placebo, rinsing placebo solution during 60 days
ACTIVE_COMPARATOR: PMSRP group; Partial-mouth scaling and root planing in 4-6 sessions in a maximum of 2 weeks	Procedure: PMSRP; Scaling and root planing in 4-6 sessions in a maximum of 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Guarulhos

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (ACTUAL): March 1, 2010
• Study Completion (ACTUAL): April 1, 2010

Study Registration Dates

• First Submitted: February 7, 2014
• First Submitted That Met QC Criteria: February 11, 2014
• First Posted (ESTIMATE): February 13, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): February 13, 2014
• Last Update Submitted That Met QC Criteria: February 11, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Cytokines; Glycated hemoglobin; microbiology; Chronic Periodontitis; Root Planing; diabetic subjects
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: SISNEP/277