1.2% Atorvastatin and 1.2% Simvastatin in Treatment of Chronic Periodontitis
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
1.2% Atorvastatin local drug delivery
1.2% simvastatin local drug delivery
Placebo local drug delivery
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring Chronic periodontitis, Local drug delivery,
Eligibility Criteria
Inclusion Criteria:
- Moderate to severe CP subjects with PD ≥ 5 mm or clinical attachment level (CAL) ≥ 4 mm and vertical bone loss ≥3 mm on intraoral periapical radiographs and no history of antibiotic or periodontal therapy in the preceding 6 months
Exclusion Criteria:
- Individuals with systemic diseases known to alter the course of periodontal disease and treatment outcome, known or suspected allergy to the SMV/ATV/statin group, those on systemic SMV/ATV/statin therapy, individuals with aggressive periodontitis, use of tobacco in any form, alcoholics, individuals with diabetes, immunocompromised individuals, and pregnant or lactating females
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Sham Comparator
Placebo Comparator
Arm Label
Atorvastatin
Simvastatin
Placebo
Arm Description
1.2% atorvastatin local drug delivery
1.2% simvastatin local drug delivery
Placebo local drug delivery
Outcomes
Primary Outcome Measures
Change in Radiographic intra-bony defect depth.
The primary outcome of the study was change in radiographic intra-bony defect depth from baseline to 9 months in all the groups. Intra-bony defect depth was measured on the radiograph by measuring the vertical distance from the crest of the alveolar bone to the base of the defect.
Secondary Outcome Measures
Change in Probing depth.
Probing depth was measured from gingival margin to the base of pocket with a University of North Carolina no. 15 color-coded periodontal probe. change in probing depth was measured from baseline to 9 months.
Change in Relative attachment level
Relative attachment level was measured from a fixed point on the acrylic stent to the to the base of pocket. . A custom-made acrylic stent and a University of North Carolina no. 15 color-coded periodontal probe were used to standardize the measurement. Change was measured from baseline to 9 months.
Change in mSBI (gingival index)
modified sulcus bleeding index was measured at baseline and 9 months and the change in the values was taken as secondary outcome measure.
Change in plaque index
Sillness and loe plaque index was measured at baseline an 9 months and change in the values was taken as secondary outcome variable.
Full Information
NCT ID
NCT02060032
First Posted
February 5, 2014
Last Updated
February 9, 2014
Sponsor
Government Dental College and Research Institute, Bangalore
1. Study Identification
Unique Protocol Identification Number
NCT02060032
Brief Title
1.2% Atorvastatin and 1.2% Simvastatin in Treatment of Chronic Periodontitis
Official Title
COMPARATIVE EVALUATION OF CLINICAL EFFICACY OF SUBGINGIVALLY DELIVERED 1.2% ATORVASTATIN AND 1.2% SIMVASTATIN IN TREATMENT OF CHRONIC PERIODONTITIS: A RANDOMIZED CONTROLLED TRIAL
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (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
Yes
5. Study Description
Brief Summary
Background: Statins are the recently evolved agents that aid in periodontal regeneration and ultimately attaining periodontal health. Atorvastatin (ATV) and Simvastatin (SMV) are specific competitive inhibitors of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. The present study was designed to evaluate and compare the effectiveness of 1.2% ATV, and 1.2% SMV as an adjunct to scaling and root planing (SRP) in the treatment subjects with chronic periodontitis.
Methods: Ninety six subjects were categorized into three treatment groups: SRP plus 1.2% ATV, SRP plus 1.2% SMV and SRP plus placebo. Clinical parameters; full mouth plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and relative attachment level (RAL) were recorded at baseline before SRP and at 3, 6 and 9 months. Percentage radiographic defect depth reduction was evaluated using computer-aided software at baseline, 6 months and 9 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Chronic periodontitis, Local drug delivery,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin
Arm Type
Active Comparator
Arm Description
1.2% atorvastatin local drug delivery
Arm Title
Simvastatin
Arm Type
Sham Comparator
Arm Description
1.2% simvastatin local drug delivery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo local drug delivery
Intervention Type
Drug
Intervention Name(s)
1.2% Atorvastatin local drug delivery
Intervention Type
Drug
Intervention Name(s)
1.2% simvastatin local drug delivery
Intervention Type
Drug
Intervention Name(s)
Placebo local drug delivery
Primary Outcome Measure Information:
Title
Change in Radiographic intra-bony defect depth.
Description
The primary outcome of the study was change in radiographic intra-bony defect depth from baseline to 9 months in all the groups. Intra-bony defect depth was measured on the radiograph by measuring the vertical distance from the crest of the alveolar bone to the base of the defect.
Time Frame
9 months from baseline
Secondary Outcome Measure Information:
Title
Change in Probing depth.
Description
Probing depth was measured from gingival margin to the base of pocket with a University of North Carolina no. 15 color-coded periodontal probe. change in probing depth was measured from baseline to 9 months.
Time Frame
9 months from baseline
Title
Change in Relative attachment level
Description
Relative attachment level was measured from a fixed point on the acrylic stent to the to the base of pocket. . A custom-made acrylic stent and a University of North Carolina no. 15 color-coded periodontal probe were used to standardize the measurement. Change was measured from baseline to 9 months.
Time Frame
9 months from baseline
Title
Change in mSBI (gingival index)
Description
modified sulcus bleeding index was measured at baseline and 9 months and the change in the values was taken as secondary outcome measure.
Time Frame
9 months from baseline
Title
Change in plaque index
Description
Sillness and loe plaque index was measured at baseline an 9 months and change in the values was taken as secondary outcome variable.
Time Frame
9 months from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Moderate to severe CP subjects with PD ≥ 5 mm or clinical attachment level (CAL) ≥ 4 mm and vertical bone loss ≥3 mm on intraoral periapical radiographs and no history of antibiotic or periodontal therapy in the preceding 6 months
Exclusion Criteria:
Individuals with systemic diseases known to alter the course of periodontal disease and treatment outcome, known or suspected allergy to the SMV/ATV/statin group, those on systemic SMV/ATV/statin therapy, individuals with aggressive periodontitis, use of tobacco in any form, alcoholics, individuals with diabetes, immunocompromised individuals, and pregnant or lactating females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avani R Pradeep, MDS
Organizational Affiliation
Professor
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
1.2% Atorvastatin and 1.2% Simvastatin in Treatment of Chronic Periodontitis
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