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Locally Delivered Atorvastatin & Rosuvastatin for Treatment of Furcation Defects in Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT02800902
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: placebo Drug: Rosuvastatin Drug: Atorvastatin Phase 2 Phase 3

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)


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: group 1
Scaling and root planing (SRP) followed by placebo gel local drug delivery
Drug: placebo
Oral prophylaxis followed by placement of placebo gel
Other Name: inactive drug

Active Comparator: group 2
SRP followed by 1.2% rosuvastatin (RSV) gel
Drug: Rosuvastatin
Oral prophylaxis followed by placement of rosuvastatin gel
Other Name: RSV

Active Comparator: group 3
SRP followed by 1.2% Atorvastatin (ATV) gel
Drug: Atorvastatin
Oral prophylaxis followed by placement of atorvastatin gel
Other Name: ATV




Primary Outcome Measures :
  1. Change in Bone defect fill [ Time Frame: baseline, 6 & 9 months ]
    Assessed in percentage


Secondary Outcome Measures :
  1. Change in modified sulcus bleeding index [ Time Frame: baseline, 6 & 9 months ]
    scale 0-3

  2. Change in Plaque index [ Time Frame: baseline, 6 & 9 months ]
    scale 0-3

  3. Change in pocket probing depth [ Time Frame: baseline, 6 & 9 months ]
    measured in mm

  4. Change in relative vertical clinical attachment level [ Time Frame: baseline, 6 & 9 months ]
    measured in mm

  5. Change in relative horizontal clinical attachment level [ Time Frame: baseline, 6 & 9 months ]
    measured in mm



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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT02800902


Locations
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India
Government Dental College and Research Institute
Bangalore, Karnataka, India, 560002
Sponsors and Collaborators
Government Dental College and Research Institute, Bangalore

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. A R Pradeep, Professor and HOD, Dept of Periodontology, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT02800902     History of Changes
Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2014-2015U8
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016

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