1.2% Rosuvastatin Subgingivally Delivered In Chronic Periodontitis With Type 2 Diabetes Mellitus
Primary Purpose
Chronic Periodontitis, Type2 Diabetes
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
SRP plus Rosuvastatin gel
SRP plus placebo gel
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetic patients with deep pockets (PD of ≥5mm or CAL ≥4mm) and vertical bone loss ≥3 mm on intraoral periapical radiographs
- Patients with ≥20 teeth with no history of periodontal therapy in the preceding 6 months nor under any antibiotic therapy
Exclusion Criteria:
- Patients with any other known systemic disease
- Patients on systemic statin therapy
- Known or suspected allergy to statin supplementation
- Patients with aggressive periodontitis
- Tobacco use in any form, smokers, alcoholics
- Immunocompromised patients
- Pregnant or lactating females
Sites / Locations
- Government Dental College and Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Rosuvastatin group
Placebo group
Arm Description
Oral prophylaxis followed by 1.2% Rosuvastatin drug in gel form placed in intrabony defects
Oral prophylaxis followed by placebo gel placement in intrabony defects
Outcomes
Primary Outcome Measures
Defect depth reduction (%)
Assessed in percentage
Secondary Outcome Measures
probing depth (mm)
measured in mm
clinical attachment level (mm)
measured in mm
modified sulcus bleeding index
scale from 0-3
plaque index
scale from 0-3
Full Information
NCT ID
NCT02985099
First Posted
December 4, 2016
Last Updated
December 4, 2016
Sponsor
Government Dental College and Research Institute, Bangalore
1. Study Identification
Unique Protocol Identification Number
NCT02985099
Brief Title
1.2% Rosuvastatin Subgingivally Delivered In Chronic Periodontitis With Type 2 Diabetes Mellitus
Official Title
1.2% Rosuvastatin Subgingivally Delivered In Treatment Of Chronic Periodontitis With Type 2 Diabetes Mellitus: A Placebo Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government Dental College and Research Institute, Bangalore
4. Oversight
5. Study Description
Brief Summary
The purpose of the present study was to evaluate the effects of subgingival delivery of 1.2% Rosuvastatin (RSV) gel as an adjunct to scaling and root planing in chronic periodontitis (CP) with Type 2 diabetes mellitus patients.
Detailed Description
Background: The purpose of this double-masked, randomized, controlled clinical trial was to evaluate the effects of subgingival delivery of 1.2% Rosuvastatin gel as an adjunct to scaling and root planing (SRP) on clinical and radiographic parameters and compare this method with SRP plus placebo gel alone in chronic periodontitis (CP) with type 2 DM patients.
Methods: Eighty CP patients with type 2 DM are included in this study. They were divided into two groups: 1) SRP + 1.2% Rosuvastatin gel (RSV group); 2) SRP + Placebo gel (Placebo group). At baseline, 3, 6 and 9 months after treatment, clinical measurements, including plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level (CAL) and radiographic parameters intrabony defect depth (IBD), percentage change in radiographic defect depth reduction (DDR%) were assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Type2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rosuvastatin group
Arm Type
Active Comparator
Arm Description
Oral prophylaxis followed by 1.2% Rosuvastatin drug in gel form placed in intrabony defects
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Oral prophylaxis followed by placebo gel placement in intrabony defects
Intervention Type
Drug
Intervention Name(s)
SRP plus Rosuvastatin gel
Intervention Description
SRP followed by 1.2% Rosuvastatin placement into intrabony defect
Intervention Type
Drug
Intervention Name(s)
SRP plus placebo gel
Intervention Description
SRP followed by placebo gel placement into intrabony defect
Primary Outcome Measure Information:
Title
Defect depth reduction (%)
Description
Assessed in percentage
Time Frame
Change from baseline to 9 months
Secondary Outcome Measure Information:
Title
probing depth (mm)
Description
measured in mm
Time Frame
Change from baseline to 9 months
Title
clinical attachment level (mm)
Description
measured in mm
Time Frame
Change from baseline to 9 months
Title
modified sulcus bleeding index
Description
scale from 0-3
Time Frame
Change from baseline to 9 months
Title
plaque index
Description
scale from 0-3
Time Frame
Change from baseline to 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetic patients with deep pockets (PD of ≥5mm or CAL ≥4mm) and vertical bone loss ≥3 mm on intraoral periapical radiographs
Patients with ≥20 teeth with no history of periodontal therapy in the preceding 6 months nor under any antibiotic therapy
Exclusion Criteria:
Patients with any other known systemic disease
Patients on systemic statin therapy
Known or suspected allergy to statin supplementation
Patients with aggressive periodontitis
Tobacco use in any form, smokers, alcoholics
Immunocompromised patients
Pregnant or lactating females
Facility Information:
Facility Name
Government Dental College and Research Institute
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India
12. IPD Sharing Statement
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1.2% Rosuvastatin Subgingivally Delivered In Chronic Periodontitis With Type 2 Diabetes Mellitus
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