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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062047
• Other study ID #: SISNEP/277
• Status: Completed
• Phase: Phase 4
• First received: February 7, 2014
• Last updated: February 11, 2014
• Start date: December 2007
• Est. completion date: April 2010

Study information

• Verified date: February 2014
• Source: University of Guarulhos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Periodontitis

Intervention

Procedure:
• FMSRP
FMSRP in a maximum of 24 hours.

Drug:
• Chlorhexidine
Application and irrigation of chlorhexidine, rinsing chlorhexidine solution during 60 days

Procedure:
• PMSRP
Scaling and root planing in 4-6 sessions in a maximum of 2 weeks

Other:
• Placebo
Application and irrigation of placebo, rinsing placebo solution during 60 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Guarulhos

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in clinical attachment level (CAL) in sites with initial PD =7mm from baseline to 12 months.		From baseline to 12 months	Yes
Secondary	Changes in percentage of sites with probing depth =5mm		From baseline to 12 months	Yes
Secondary	Changes in serum levels of glycemic hemoglobin		From baseline to 12 months	Yes
Secondary	Changes in the counts of pathogenic bacterial species		From baseline to 12 months	Yes
Secondary	Changes in the levels of tumor necrosis factor-a in gingival crevicular fluid		From baseline to 12 months	Yes
Secondary	Changes in the levels of plaque accumulation		From baseline to 12 months	Yes
Secondary	Changes in the mean percentage of sites with bleeding on probing		From baseline to 12 months	Yes
Secondary	Changes in the full-mouth probing depth		From baseline to 12 months	Yes
Secondary	Changes in the serum levels of fasting plasma glucose		From baseline to 12 months	Yes
Secondary	Changes in the proportions of pathogenic bacterial species		From baseline to 12 months	Yes
Secondary	Changes in the levels of interferon (IFN)-? in gingival crevicular fluid		From baseline to 12 months	Yes
Secondary	Changes in the levels of interleukin (IL)-17 in gingival crevicular fluid		From baseline to 12 months	Yes
Secondary	Changes in the levels of IL-23 in gingival crevicular fluid		From baseline to 12 months	Yes
Secondary	Changes in the levels of IL-4 in gingival crevicular fluid		From baseline to 12 months	Yes
Secondary	Changes in levels of receptor activator of NF-?ß ligand (RANKL) in gingival crevicular fluid		From baseline to 12 months	Yes
Secondary	Changes in the levels of osteoprotegerin (OPG) in gingival crevicular fluid		From baseline to 12 months	Yes