Comparison of Alendronate With Atorvastatin in Chronic Periodontitis

Comparative Evaluation of Subgingivally Delivered 1% Alendronate Versus 1.2% Atorvastatin Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: SRP and Placebo gel; Drug: SRP and Atorvastatin; Drug: SRP and Alendronate

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in defect depth reduction from baseline to 6 months and from baseline to 9 months	Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval	Baseline to 6 months and Baseline to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque index	Plaque index will be measured at 3, 6 and 9 months	3,6 and 9 months
Modified sulcus bleeding index	Modified sulcus bleeding index will be measured at 3, 6 and 9 months	3,6 and 9 months]
Probing pocket depth	Probing pocket depth will be measured at 3, 6 and 9 months	3,6 and 9 months]
Clinical attachment level	Clinical attachment level will be measured at 3, 6 and 9 months	3,6 and 9 months]

Collaborators and Investigators

• Sponsor: Government Dental College and Research Institute, Bangalore

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: May 19, 2015
• First Submitted That Met QC Criteria: May 25, 2015
• First Posted (Estimate): May 28, 2015

Study Record Updates

• Last Update Posted (Estimate): May 28, 2015
• Last Update Submitted That Met QC Criteria: May 25, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Bone Density Conservation Agents; Atorvastatin; Alendronate
• Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2013-2014J