A Phase 2/3 interventional study of SRP plus Rosuvastatin gel and SRP plus placebo gel in Chronic Periodontitis, sponsored by Government Dental College and Research Institute, Bangalore. Completed at 1 site in India. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-03.
Sponsored by Government Dental College and Research Institute, Bangalore · Phase 2/3, Interventional, and Treatment
The purpose of the present study was to evaluate the effects of subgingival delivery of Rosuvastatin gel as an adjunct to scaling and root planing in Smokers With Chronic Periodontitis (CP) patients.
Background: Periodontal diseases are multi-factorial in etiology, and bacteria are one among these etiologic agents. However, mechanical therapy itself may not always reduce or eliminate the anaerobic infection at the base of the pocket, within the gingival tissues. To overcome this, various systemic and local drug delivered antimicrobials have been used as an adjunct to scaling and root planing (SRP).The present study aims to explore the efficacy of 1.2% rosuvastatin (RSV) gel local drug delivery as an adjunct to SRP in smokers with chronic periodontitis (CP).
Methods: Sixty subjects were randomly allocated into two treatment groups: SRP with placebo gel (group 1), SRP with 1.2% RSV gel (group 2). Clinical parameters were recorded at baseline, 6 and 9 months. Radiographic assessment was done using computer aided software at baseline, 6 and 9 months.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 60 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Government Dental College and Research Institute, Bangalore is the lead sponsor of 38 studies on the registry; none are open to participants now.
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A subject was considered as a current smoker if he regularly smoked more than 10 cigarettes/day for a minimum of 5 years
Exclusion Criteria:
Oral prophylaxis followed by 1.2% Rosuvastatin drug in gel form placed in intrabony defects
Drug: SRP plus Rosuvastatin gel
Oral prophylaxis followed by placebo gel placement in intrabony defects
Drug: SRP plus placebo gel
SRP followed by Rosuvastatin placement into intrabony defect
SRP followed by placebo gel placement into intrabony defect
Defect depth reduction (%)
assessed in percentage
Time frame: Change from baseline to 9 months
probing depth (mm)
measured in mm
Time frame: Change from baseline to 9 months
clinical attachment level (mm)
measured in mm
Time frame: Change from baseline to 9 months
modified sulcus bleeding index
scale from 0-3
Time frame: Change from baseline to 9 months
Plaque Index
scale from 0-3
Time frame: Change from baseline to 9 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Government Dental College and Research Institute, Bangalore