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

NCT02062047 | Completed Phase 4 DMC

• 1 other identifier: SISNEP/277
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Keywords

Diabetes Mellitus; Chronic Periodontitis; Root Planing; Cytokines; microbiology; Glycated hemoglobin; diabetic subjects

Outcome Measures

Primary Outcomes (1)

• Changes in clinical attachment level (CAL) in sites with initial PD ≥7mm from baseline to 12 months.

  From baseline to 12 months

Secondary Outcomes (15)

• 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

Study Arms (3)

FMSRP+CLX

EXPERIMENTAL

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; Drug: Chlorhexidine

FMSRP + placebo group

PLACEBO COMPARATOR

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; Other: Placebo

PMSRP group

ACTIVE COMPARATOR

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

Procedure: PMSRP

Interventions

FMSRP PROCEDURE

FMSRP in a maximum of 24 hours.

FMSRP + placebo group; FMSRP+CLX

Chlorhexidine DRUG

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

Also known as: (N/A)

FMSRP+CLX

PMSRP PROCEDURE

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

PMSRP group

Placebo OTHER

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

FMSRP + placebo group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Guarulhos: lead

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus; Chronic Periodontitis

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 13, 2014
• Study Start: December 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 13, 2014

Record last verified: 2014-02