Chronic Periodontitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
SRP followed by Rosuvastatin placement into intrabony defect
SRP followed by placebo gel placement into intrabony defect
Sponsors
Government Dental College and Research Institute, Bangalore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Systemically healthy CP subjects aged between 30-50 years who are current smokers with no history of periodontal therapy or use of antibiotics in past 6 months, having sites with intrabony defect depth (IBD) ≥ 3mm (distance between alveolar crest and base of the defect on intraoral periapical radiograph) along with PPD ≥5 mm or CAL ≥3 mm in an asymptomatic tooth were included in the study. 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
* Former smokers, i.e. subjects who had previously been smokers but stopped their habit, and non-smokers were excluded. Subjects allergic to statins, on systemic statin therapy, with any known systemic disease or any other systemic inflammation/ infection which could alter the course of periodontal disease and users of tobacco in any other form than cigarettes were excluded from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Defect depth reduction (%) | Change from baseline to 9 months | assessed in percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| probing depth (mm) | Change from baseline to 9 months | measured in mm |
| clinical attachment level (mm) | Change from baseline to 9 months | measured in mm |
| modified sulcus bleeding index | Change from baseline to 9 months | scale from 0-3 |
| Plaque Index | Change from baseline to 9 months | scale from 0-3 |
Countries
India
Outcome results
None listed