1.2% Rosuvastatin Subgingivally Delivered In Chronic Periodontitis With Type 2 Diabetes Mellitus
NCT ID: NCT02985099
Last Updated: 2016-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
80 participants
INTERVENTIONAL
2015-11-30
2016-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Rosuvastatin group
Oral prophylaxis followed by 1.2% Rosuvastatin drug in gel form placed in intrabony defects
SRP plus Rosuvastatin gel
SRP followed by 1.2% Rosuvastatin placement into intrabony defect
Placebo group
Oral prophylaxis followed by placebo gel placement in intrabony defects
SRP plus placebo gel
SRP followed by placebo gel placement into intrabony defect
Interventions
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SRP plus Rosuvastatin gel
SRP followed by 1.2% Rosuvastatin placement into intrabony defect
SRP plus placebo gel
SRP followed by placebo gel placement into intrabony defect
Eligibility Criteria
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Inclusion Criteria
* Patients with ≥20 teeth with no history of periodontal therapy in the preceding 6 months nor under any antibiotic therapy
Exclusion Criteria
* 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
30 Years
55 Years
ALL
Yes
Sponsors
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Government Dental College and Research Institute, Bangalore
OTHER
Responsible Party
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Dr. A R Pradeep
Professor and Head, Dept of Periodontology
Locations
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Government Dental College and Research Institute
Bangalore, Karnataka, India
Countries
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Other Identifiers
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GDCRI/ACM/PG/PhD/2/2013-2014DK
Identifier Type: -
Identifier Source: org_study_id