- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02800902
Locally Delivered Atorvastatin & Rosuvastatin for Treatment of Furcation Defects in Chronic Periodontitis
Comparative Evaluation of Locally Delivered 1.2% Atorvastatin and 1.2% Rosuvastatin Gel in Treatment of Mandibular Degree ii Furcation Defects in Chronic Periodontitis Subjects: A Randomized Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV) have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims to explore the efficacy of 1.2% RSV and 1.2% ATV gel as a local drug delivery and redelivery system as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects.
Methods: Ninety patients with mandibular buccal class II furcation defects were randomly allocated into three treatment groups: SRP plus placebo gel (group 1), SRP plus 1.2% RSV gel (group 2) and 1.2% ATV gel (group3). Clinical and radiographic parameters were recorded at baseline then after 6 months. The gels were redelivered at the respective sites at this 6 month appointment. Then again all clinical and radiographic parameters were recorded after 3 months. (9 months from baseline)
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Karnataka
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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:
- Systemically healthy patients with mandibular class II furcation defects and asymptomatic endodontically vital mandibular molars with radiolucency in furcation area with PD ≥ 5mm and horizontal PD ≥ 3mm and with no history of antibiotic or any periodontal therapy in past 6 months were included in the study
Exclusion Criteria:
- Subjects with any known systemic disease, allergic to statins, on systemic statin therapy, alcoholics, tobacco users, pregnant or lactating women
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: group 1
Scaling and root planing (SRP) followed by placebo gel local drug delivery
|
Oral prophylaxis followed by placement of placebo gel
Other Names:
|
Active Comparator: group 2
SRP followed by 1.2% rosuvastatin (RSV) gel
|
Oral prophylaxis followed by placement of rosuvastatin gel
Other Names:
|
Active Comparator: group 3
SRP followed by 1.2% Atorvastatin (ATV) gel
|
Oral prophylaxis followed by placement of atorvastatin gel
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Bone defect fill
Time Frame: baseline, 6 & 9 months
|
Assessed in percentage
|
baseline, 6 & 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in modified sulcus bleeding index
Time Frame: baseline, 6 & 9 months
|
scale 0-3
|
baseline, 6 & 9 months
|
Change in Plaque index
Time Frame: baseline, 6 & 9 months
|
scale 0-3
|
baseline, 6 & 9 months
|
Change in pocket probing depth
Time Frame: baseline, 6 & 9 months
|
measured in mm
|
baseline, 6 & 9 months
|
Change in relative vertical clinical attachment level
Time Frame: baseline, 6 & 9 months
|
measured in mm
|
baseline, 6 & 9 months
|
Change in relative horizontal clinical attachment level
Time Frame: baseline, 6 & 9 months
|
measured in mm
|
baseline, 6 & 9 months
|
Collaborators and Investigators
Publications and helpful links
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
- Stomatognathic Diseases
- Periodontal Diseases
- Mouth Diseases
- Periodontitis
- Chronic Periodontitis
- Furcation Defects
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
- Rosuvastatin Calcium
Other Study ID Numbers
- GDCRI/ACM/PG/PhD/2/2014-2015U8
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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