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

Primary Purpose

Periodontitis, Diabetes

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
FMSRP
Chlorhexidine
PMSRP
Placebo
Sponsored by
University of Guarulhos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Diabetes Mellitus, Chronic Periodontitis, Root Planing, Cytokines, microbiology, Glycated hemoglobin, diabetic subjects

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Placebo Comparator

    Active Comparator

    Arm Label

    FMSRP+CLX

    FMSRP + placebo group

    PMSRP group

    Arm Description

    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

    Full-mouth scaling and root planing in a maximum of 24 hours, application and irrigation of placebo, rinsing placebo solution during 60 days

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Changes in percentage of sites with probing depth ≥5mm
    Changes in serum levels of glycemic hemoglobin
    Changes in the counts of pathogenic bacterial species
    Changes in the levels of tumor necrosis factor-α in gingival crevicular fluid
    Changes in the levels of plaque accumulation
    Changes in the mean percentage of sites with bleeding on probing
    Changes in the full-mouth probing depth
    Changes in the serum levels of fasting plasma glucose
    Changes in the proportions of pathogenic bacterial species
    Changes in the levels of interferon (IFN)-γ in gingival crevicular fluid
    Changes in the levels of interleukin (IL)-17 in gingival crevicular fluid
    Changes in the levels of IL-23 in gingival crevicular fluid
    Changes in the levels of IL-4 in gingival crevicular fluid
    Changes in levels of receptor activator of NF-κß ligand (RANKL) in gingival crevicular fluid
    Changes in the levels of osteoprotegerin (OPG) in gingival crevicular fluid

    Full Information

    First Posted
    February 7, 2014
    Last Updated
    February 11, 2014
    Sponsor
    University of Guarulhos
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02062047
    Brief Title
    Full-mouth and Partial-mouth Scaling and Root Planing in Type 2 Diabetic Subjects
    Official Title
    Full-mouth and Partial-mouth Scaling and Root Planing in Type 2 Diabetic Subjects: Clinical, Immunological and Microbiological Outcomes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2007 (undefined)
    Primary Completion Date
    March 2010 (Actual)
    Study Completion Date
    April 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Guarulhos

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis, Diabetes
    Keywords
    Diabetes Mellitus, Chronic Periodontitis, Root Planing, Cytokines, microbiology, Glycated hemoglobin, diabetic subjects

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FMSRP+CLX
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    FMSRP + placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Full-mouth scaling and root planing in a maximum of 24 hours, application and irrigation of placebo, rinsing placebo solution during 60 days
    Arm Title
    PMSRP group
    Arm Type
    Active Comparator
    Arm Description
    Partial-mouth scaling and root planing in 4-6 sessions in a maximum of 2 weeks
    Intervention Type
    Procedure
    Intervention Name(s)
    FMSRP
    Intervention Description
    FMSRP in a maximum of 24 hours.
    Intervention Type
    Drug
    Intervention Name(s)
    Chlorhexidine
    Other Intervention Name(s)
    (N/A)
    Intervention Description
    Application and irrigation of chlorhexidine, rinsing chlorhexidine solution during 60 days
    Intervention Type
    Procedure
    Intervention Name(s)
    PMSRP
    Intervention Description
    Scaling and root planing in 4-6 sessions in a maximum of 2 weeks
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Application and irrigation of placebo, rinsing placebo solution during 60 days
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Changes in percentage of sites with probing depth ≥5mm
    Time Frame
    From baseline to 12 months
    Title
    Changes in serum levels of glycemic hemoglobin
    Time Frame
    From baseline to 12 months
    Title
    Changes in the counts of pathogenic bacterial species
    Time Frame
    From baseline to 12 months
    Title
    Changes in the levels of tumor necrosis factor-α in gingival crevicular fluid
    Time Frame
    From baseline to 12 months
    Title
    Changes in the levels of plaque accumulation
    Time Frame
    From baseline to 12 months
    Title
    Changes in the mean percentage of sites with bleeding on probing
    Time Frame
    From baseline to 12 months
    Title
    Changes in the full-mouth probing depth
    Time Frame
    From baseline to 12 months
    Title
    Changes in the serum levels of fasting plasma glucose
    Time Frame
    From baseline to 12 months
    Title
    Changes in the proportions of pathogenic bacterial species
    Time Frame
    From baseline to 12 months
    Title
    Changes in the levels of interferon (IFN)-γ in gingival crevicular fluid
    Time Frame
    From baseline to 12 months
    Title
    Changes in the levels of interleukin (IL)-17 in gingival crevicular fluid
    Time Frame
    From baseline to 12 months
    Title
    Changes in the levels of IL-23 in gingival crevicular fluid
    Time Frame
    From baseline to 12 months
    Title
    Changes in the levels of IL-4 in gingival crevicular fluid
    Time Frame
    From baseline to 12 months
    Title
    Changes in levels of receptor activator of NF-κß ligand (RANKL) in gingival crevicular fluid
    Time Frame
    From baseline to 12 months
    Title
    Changes in the levels of osteoprotegerin (OPG) in gingival crevicular fluid
    Time Frame
    From baseline to 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

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

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