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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

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.


Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: 1.2% Atorvastatin local drug delivery Drug: 1.2% simvastatin local drug delivery Drug: Placebo local drug delivery Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Atorvastatin
1.2% atorvastatin local drug delivery
Drug: 1.2% Atorvastatin local drug delivery
Sham Comparator: Simvastatin
1.2% simvastatin local drug delivery
Drug: 1.2% simvastatin local drug delivery
Placebo Comparator: Placebo
Placebo local drug delivery
Drug: Placebo local drug delivery



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060032


Sponsors and Collaborators
Government Dental College and Research Institute, Bangalore
Investigators
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Principal Investigator: Avani R Pradeep, MDS Professor

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Responsible Party: Dr. A R Pradeep, Professor, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT02060032     History of Changes
Other Study ID Numbers: GDCRI/ACM/PG/PhD/2011-2012/B
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: February 2014

Keywords provided by Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore:
Chronic periodontitis, Local drug delivery,

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Atorvastatin
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors