- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02985099
1.2% Rosuvastatin Subgingivally Delivered In Chronic Periodontitis With Type 2 Diabetes Mellitus
1.2% Rosuvastatin Subgingivally Delivered In Treatment Of Chronic Periodontitis With Type 2 Diabetes Mellitus: A Placebo Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Karnataka
-
Bangalore, Karnataka, India, 560002
- Government Dental College and Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo group
Oral prophylaxis followed by placebo gel placement in intrabony defects
|
SRP followed by placebo gel placement into intrabony defect
|
Active Comparator: Rosuvastatin group
Oral prophylaxis followed by 1.2% Rosuvastatin drug in gel form placed in intrabony defects
|
SRP followed by 1.2% Rosuvastatin placement into intrabony defect
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Defect depth reduction (%)
Time Frame: Change from baseline to 9 months
|
Assessed in percentage
|
Change from baseline to 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
probing depth (mm)
Time Frame: Change from baseline to 9 months
|
measured in mm
|
Change from baseline to 9 months
|
clinical attachment level (mm)
Time Frame: Change from baseline to 9 months
|
measured in mm
|
Change from baseline to 9 months
|
modified sulcus bleeding index
Time Frame: Change from baseline to 9 months
|
scale from 0-3
|
Change from baseline to 9 months
|
plaque index
Time Frame: Change from baseline to 9 months
|
scale from 0-3
|
Change from baseline to 9 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Stomatognathic Diseases
- Periodontal Diseases
- Mouth Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Periodontitis
- Chronic Periodontitis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Rosuvastatin Calcium
Other Study ID Numbers
- GDCRI/ACM/PG/PhD/2/2013-2014DK
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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