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Comparison of Alendronate With Atorvastatin in Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT02455869
Recruitment Status : Completed
First Posted : May 28, 2015
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

Brief Summary:
The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of two local drug delivery systems containing 1% ALN gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: SRP and Placebo gel Drug: SRP and Atorvastatin Drug: SRP and Alendronate Phase 2 Phase 3

Detailed Description:

Background: Alendronate and Atorvastatin are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of 1% ALN and 1.2% ATV gel as a local drug delivery system in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis.

Methods: A total of 90 intrabony defects were treated with either1%ALN, 1.2% ATV or placebo gel. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth [PD], and clinical attachment level [CAL]) were recorded at baseline, 3, 6 and 9 months. Radiographic parameters intrabony defect depth (IBD) and defect depth reduction (DDR%) was calculated on standardized radiographs by using image analysis software at 6 and 9 months.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Comparative Evaluation of Subgingivally Delivered 1% Alendronate Versus 1.2% Atorvastatin Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial
Study Start Date : July 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

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Arm Intervention/treatment
Placebo Comparator: Placebo group
SRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket
Drug: SRP and Placebo gel
After SRP, placebo gel was delivered subgingivally into the pocket

Active Comparator: Atorvastatin group
SRP plus Atorvastatin SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally
Drug: SRP and Atorvastatin
After SRP, Atorvastatin gel was delivered subgingivally into the pocket

Active Comparator: Alendronate Group
Alendronate SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally
Drug: SRP and Alendronate
After SRP, Alendronate gel was delivered subgingivally into the pocket




Primary Outcome Measures :
  1. Change in defect depth reduction from baseline to 6 months and from baseline to 9 months [ Time Frame: Baseline to 6 months and Baseline to 9 months ]
    Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval


Secondary Outcome Measures :
  1. Plaque index [ Time Frame: 3,6 and 9 months ]
    Plaque index will be measured at 3, 6 and 9 months

  2. Modified sulcus bleeding index [ Time Frame: 3,6 and 9 months] ]
    Modified sulcus bleeding index will be measured at 3, 6 and 9 months

  3. Probing pocket depth [ Time Frame: 3,6 and 9 months] ]
    Probing pocket depth will be measured at 3, 6 and 9 months

  4. Clinical attachment level [ Time Frame: 3,6 and 9 months] ]
    Clinical attachment level will be measured at 3, 6 and 9 months



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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 PDs ≥5mm or CALs ≥4 to 6mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included

Exclusion Criteria:

  • Patients with a known systemic disease;
  • known or suspected allergy to the ALN/bisphosphonate group and ATV/statin group;
  • on systemic ALN/bisphosphonate and therapy ATV/statin group;
  • with aggressive periodontitis;
  • who used tobacco in any form;
  • alcoholics;
  • immunocompromised patients;
  • and pregnant or lactating females were excluded from the study

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Responsible Party: Dr. A R Pradeep, Professor, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT02455869     History of Changes
Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2013-2014J
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
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Chronic Periodontitis
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Atorvastatin
Alendronate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Bone Density Conservation Agents
Physiological Effects of Drugs