A Phase 2/3 interventional study of SRP plus Rosuvastatin gel and SRP plus placebo gel in Chronic Periodontitis and Type2 Diabetes, sponsored by Government Dental College and Research Institute, Bangalore. Completed at 1 site in India. Open to participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-07.
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 1.2% Rosuvastatin (RSV) gel as an adjunct to scaling and root planing in chronic periodontitis (CP) with Type 2 diabetes mellitus patients.
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 80 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.
Counted across the registry records on this site, refreshed daily.
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 1.2% 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
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Government Dental College and Research Institute, Bangalore