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1.2% Atorvastatin and 1.2% Simvastatin in Treatment of Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT02060032
Recruitment Status : Completed
First Posted : February 11, 2014
Last Update Posted : February 11, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

Tracking Information
First Submitted Date  ICMJE February 5, 2014
First Posted Date  ICMJE February 11, 2014
Last Update Posted Date February 11, 2014
Study Start Date  ICMJE February 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2014)
Change in Radiographic intra-bony defect depth. [ Time Frame: 9 months from baseline ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2014)
  • Change in Probing depth. [ Time Frame: 9 months from baseline ]
    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 [ Time Frame: 9 months from baseline ]
    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) [ Time Frame: 9 months from baseline ]
    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 [ Time Frame: 9 months from baseline ]
    Sillness and loe plaque index was measured at baseline an 9 months and change in the values was taken as secondary outcome variable.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 1.2% Atorvastatin and 1.2% Simvastatin in Treatment of Chronic Periodontitis
Official Title  ICMJE COMPARATIVE EVALUATION OF CLINICAL EFFICACY OF SUBGINGIVALLY DELIVERED 1.2% ATORVASTATIN AND 1.2% SIMVASTATIN IN TREATMENT OF CHRONIC PERIODONTITIS: A RANDOMIZED CONTROLLED TRIAL
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Periodontitis
Intervention  ICMJE
  • Drug: 1.2% Atorvastatin local drug delivery
  • Drug: 1.2% simvastatin local drug delivery
  • Drug: Placebo local drug delivery
Study Arms  ICMJE
  • Active Comparator: Atorvastatin
    1.2% atorvastatin local drug delivery
    Intervention: Drug: 1.2% Atorvastatin local drug delivery
  • Sham Comparator: Simvastatin
    1.2% simvastatin local drug delivery
    Intervention: Drug: 1.2% simvastatin local drug delivery
  • Placebo Comparator: Placebo
    Placebo local drug delivery
    Intervention: Drug: Placebo local drug delivery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2014)
96
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02060032
Other Study ID Numbers  ICMJE GDCRI/ACM/PG/PhD/2011-2012/B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore
Study Sponsor  ICMJE Government Dental College and Research Institute, Bangalore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Avani R Pradeep, MDS Professor
PRS Account Government Dental College and Research Institute, Bangalore
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP