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

NCT ID: NCT02062047

Last Updated: 2014-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2010-04-30

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.

Conditions

Periodontitis; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

FMSRP

Intervention Type: PROCEDURE

FMSRP in a maximum of 24 hours.

Chlorhexidine

Intervention Type: DRUG

Application and irrigation of chlorhexidine, rinsing chlorhexidine solution during 60 days

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

Group Type: PLACEBO_COMPARATOR

FMSRP

Intervention Type: PROCEDURE

FMSRP in a maximum of 24 hours.

Placebo

Intervention Type: OTHER

Application and irrigation of placebo, rinsing placebo solution during 60 days

PMSRP group

Partial-mouth scaling and root planing in 4-6 sessions in a maximum of 2 weeks

Group Type: ACTIVE_COMPARATOR

PMSRP

Intervention Type: PROCEDURE

Scaling and root planing in 4-6 sessions in a maximum of 2 weeks

Interventions

FMSRP

FMSRP in a maximum of 24 hours.

Intervention Type: PROCEDURE

Chlorhexidine

Application and irrigation of chlorhexidine, rinsing chlorhexidine solution during 60 days

Intervention Type: DRUG

PMSRP

Scaling and root planing in 4-6 sessions in a maximum of 2 weeks

Intervention Type: PROCEDURE

Placebo

Application and irrigation of placebo, rinsing placebo solution during 60 days

Intervention Type: OTHER

Other Intervention Names

(N/A)

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Guarulhos

OTHER

Sponsor Role: lead

Responsible Party

Poliana Mendes Duarte

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SISNEP/277

Identifier Type: -

Identifier Source: org_study_id