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

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ClinicalTrials.gov Identifier: NCT02062047
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : February 13, 2014
Sponsor:
Information provided by (Responsible Party):
Poliana Mendes Duarte, University of Guarulhos

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.

Condition or disease Intervention/treatment Phase
Periodontitis Diabetes Procedure: FMSRP Drug: Chlorhexidine Procedure: PMSRP Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Full-mouth and Partial-mouth Scaling and Root Planing in Type 2 Diabetic Subjects: Clinical, Immunological and Microbiological Outcomes
Study Start Date : December 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010

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 Name: (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




Primary Outcome Measures :
  1. Changes in clinical attachment level (CAL) in sites with initial PD ≥7mm from baseline to 12 months. [ Time Frame: From baseline to 12 months ]

Secondary Outcome Measures :
  1. Changes in percentage of sites with probing depth ≥5mm [ Time Frame: From baseline to 12 months ]
  2. Changes in serum levels of glycemic hemoglobin [ Time Frame: From baseline to 12 months ]
  3. Changes in the counts of pathogenic bacterial species [ Time Frame: From baseline to 12 months ]
  4. Changes in the levels of tumor necrosis factor-α in gingival crevicular fluid [ Time Frame: From baseline to 12 months ]
  5. Changes in the levels of plaque accumulation [ Time Frame: From baseline to 12 months ]
  6. Changes in the mean percentage of sites with bleeding on probing [ Time Frame: From baseline to 12 months ]
  7. Changes in the full-mouth probing depth [ Time Frame: From baseline to 12 months ]
  8. Changes in the serum levels of fasting plasma glucose [ Time Frame: From baseline to 12 months ]
  9. Changes in the proportions of pathogenic bacterial species [ Time Frame: From baseline to 12 months ]
  10. Changes in the levels of interferon (IFN)-γ in gingival crevicular fluid [ Time Frame: From baseline to 12 months ]
  11. Changes in the levels of interleukin (IL)-17 in gingival crevicular fluid [ Time Frame: From baseline to 12 months ]
  12. Changes in the levels of IL-23 in gingival crevicular fluid [ Time Frame: From baseline to 12 months ]
  13. Changes in the levels of IL-4 in gingival crevicular fluid [ Time Frame: From baseline to 12 months ]
  14. Changes in levels of receptor activator of NF-κß ligand (RANKL) in gingival crevicular fluid [ Time Frame: From baseline to 12 months ]
  15. Changes in the levels of osteoprotegerin (OPG) in gingival crevicular fluid [ Time Frame: From baseline to 12 months ]


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Poliana Mendes Duarte, PhD, University of Guarulhos
ClinicalTrials.gov Identifier: NCT02062047     History of Changes
Other Study ID Numbers: SISNEP/277
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014

Keywords provided by Poliana Mendes Duarte, University of Guarulhos:
Diabetes Mellitus
Chronic Periodontitis
Root Planing
Cytokines
microbiology
Glycated hemoglobin
diabetic subjects

Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Pharmaceutical Solutions
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents