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
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
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
NCT ID
NCT02062047
First Posted
February 7, 2014
Last Updated
February 11, 2014
Sponsor
University of Guarulhos
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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