Back to results1.2% Rosuvastatin Gel As A Local Agent In Smokers With Chronic Periodontitis
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
SRP plus Rosuvastatin gel
SRP plus placebo gel
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
Eligibility Criteria
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
Sites / Locations
- Government Dental College and Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Rosuvastatin Group
Placebo Group
Arm Description
Oral prophylaxis followed by 1.2% Rosuvastatin drug in gel form placed in intrabony defects
Oral prophylaxis followed by placebo gel placement in intrabony defects
Outcomes
Primary Outcome Measures
Defect depth reduction (%)
assessed in percentage
Secondary Outcome Measures
probing depth (mm)
measured in mm
clinical attachment level (mm)
measured in mm
modified sulcus bleeding index
scale from 0-3
Plaque Index
scale from 0-3
Full Information
NCT ID
NCT03043196
First Posted
February 2, 2017
Last Updated
February 2, 2017
Sponsor
Government Dental College and Research Institute, Bangalore
1. Study Identification
Unique Protocol Identification Number
NCT03043196
Brief Title
1.2% Rosuvastatin Gel As A Local Agent In Smokers With Chronic Periodontitis
Official Title
1.2% Rosuvastatin Gel As A Local Drug Delivery Agent In Smokers With Chronic Periodontitis- A Randomized Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government Dental College and Research Institute, Bangalore
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rosuvastatin Group
Arm Type
Active Comparator
Arm Description
Oral prophylaxis followed by 1.2% Rosuvastatin drug in gel form placed in intrabony defects
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Oral prophylaxis followed by placebo gel placement in intrabony defects
Intervention Type
Drug
Intervention Name(s)
SRP plus Rosuvastatin gel
Intervention Description
SRP followed by Rosuvastatin placement into intrabony defect
Intervention Type
Drug
Intervention Name(s)
SRP plus placebo gel
Intervention Description
SRP followed by placebo gel placement into intrabony defect
Primary Outcome Measure Information:
Title
Defect depth reduction (%)
Description
assessed in percentage
Time Frame
Change from baseline to 9 months
Secondary Outcome Measure Information:
Title
probing depth (mm)
Description
measured in mm
Time Frame
Change from baseline to 9 months
Title
clinical attachment level (mm)
Description
measured in mm
Time Frame
Change from baseline to 9 months
Title
modified sulcus bleeding index
Description
scale from 0-3
Time Frame
Change from baseline to 9 months
Title
Plaque Index
Description
scale from 0-3
Time Frame
Change from baseline to 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Government Dental College and Research Institute
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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1.2% Rosuvastatin Gel As A Local Agent In Smokers With Chronic Periodontitis
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