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Completed

NCT Number: NCT02062047

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FMSRP

Procedure

FMSRP in a maximum of 24 hours.

Chlorhexidine

Drug

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

Other names: (N/A)

PMSRP

Procedure

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

Placebo

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Guarulhos

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 13, 2014
Registry last updated
Feb 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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