Locally Delivered Atorvastatin & Rosuvastatin for Treatment of Furcation Defects in Chronic Periodontitis
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
placebo
Rosuvastatin
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
Eligibility Criteria
Inclusion Criteria:
- Systemically healthy patients with mandibular class II furcation defects and asymptomatic endodontically vital mandibular molars with radiolucency in furcation area with PD ≥ 5mm and horizontal PD ≥ 3mm and with no history of antibiotic or any periodontal therapy in past 6 months were included in the study
Exclusion Criteria:
- Subjects with any known systemic disease, allergic to statins, on systemic statin therapy, alcoholics, tobacco users, pregnant or lactating women
Sites / Locations
- Government Dental College and Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
group 1
group 2
group 3
Arm Description
Scaling and root planing (SRP) followed by placebo gel local drug delivery
SRP followed by 1.2% rosuvastatin (RSV) gel
SRP followed by 1.2% Atorvastatin (ATV) gel
Outcomes
Primary Outcome Measures
Change in Bone defect fill
Assessed in percentage
Secondary Outcome Measures
Change in modified sulcus bleeding index
scale 0-3
Change in Plaque index
scale 0-3
Change in pocket probing depth
measured in mm
Change in relative vertical clinical attachment level
measured in mm
Change in relative horizontal clinical attachment level
measured in mm
Full Information
NCT ID
NCT02800902
First Posted
June 7, 2016
Last Updated
June 14, 2016
Sponsor
Government Dental College and Research Institute, Bangalore
1. Study Identification
Unique Protocol Identification Number
NCT02800902
Brief Title
Locally Delivered Atorvastatin & Rosuvastatin for Treatment of Furcation Defects in Chronic Periodontitis
Official Title
Comparative Evaluation of Locally Delivered 1.2% Atorvastatin and 1.2% Rosuvastatin Gel in Treatment of Mandibular Degree ii Furcation Defects in Chronic Periodontitis Subjects: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 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
5. Study Description
Brief Summary
Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV) have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims to explore the efficacy of 1.2% RSV and 1.2% ATV gel as a local drug delivery and redelivery system as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects.
Detailed Description
Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV) have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims to explore the efficacy of 1.2% RSV and 1.2% ATV gel as a local drug delivery and redelivery system as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects.
Methods: Ninety patients with mandibular buccal class II furcation defects were randomly allocated into three treatment groups: SRP plus placebo gel (group 1), SRP plus 1.2% RSV gel (group 2) and 1.2% ATV gel (group3). Clinical and radiographic parameters were recorded at baseline then after 6 months. The gels were redelivered at the respective sites at this 6 month appointment. Then again all clinical and radiographic parameters were recorded after 3 months. (9 months from baseline)
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
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Placebo Comparator
Arm Description
Scaling and root planing (SRP) followed by placebo gel local drug delivery
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
SRP followed by 1.2% rosuvastatin (RSV) gel
Arm Title
group 3
Arm Type
Active Comparator
Arm Description
SRP followed by 1.2% Atorvastatin (ATV) gel
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
inactive drug
Intervention Description
Oral prophylaxis followed by placement of placebo gel
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
RSV
Intervention Description
Oral prophylaxis followed by placement of rosuvastatin gel
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
ATV
Intervention Description
Oral prophylaxis followed by placement of atorvastatin gel
Primary Outcome Measure Information:
Title
Change in Bone defect fill
Description
Assessed in percentage
Time Frame
baseline, 6 & 9 months
Secondary Outcome Measure Information:
Title
Change in modified sulcus bleeding index
Description
scale 0-3
Time Frame
baseline, 6 & 9 months
Title
Change in Plaque index
Description
scale 0-3
Time Frame
baseline, 6 & 9 months
Title
Change in pocket probing depth
Description
measured in mm
Time Frame
baseline, 6 & 9 months
Title
Change in relative vertical clinical attachment level
Description
measured in mm
Time Frame
baseline, 6 & 9 months
Title
Change in relative horizontal clinical attachment level
Description
measured in mm
Time Frame
baseline, 6 & 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 patients with mandibular class II furcation defects and asymptomatic endodontically vital mandibular molars with radiolucency in furcation area with PD ≥ 5mm and horizontal PD ≥ 3mm and with no history of antibiotic or any periodontal therapy in past 6 months were included in the study
Exclusion Criteria:
Subjects with any known systemic disease, allergic to statins, on systemic statin therapy, alcoholics, tobacco users, pregnant or lactating women
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
Citations:
PubMed Identifier
27715376
Citation
Garg S, Pradeep AR. 1.2% Rosuvastatin and 1.2% Atorvastatin Gel Local Drug Delivery and Redelivery in the Treatment of Class II Furcation Defects: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Mar;88(3):259-265. doi: 10.1902/jop.2016.160399. Epub 2016 Oct 7.
Results Reference
derived
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Locally Delivered Atorvastatin & Rosuvastatin for Treatment of Furcation Defects in Chronic Periodontitis
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