Comparison of Alendronate With Atorvastatin in Chronic Periodontitis

Government Dental College and Research Institute, Bangalore104 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

104

Conditions

Chronic Periodontitis

Interventions

SRP and Placebo gelDRUG

After SRP, placebo gel was delivered subgingivally into the pocket

SRP and AtorvastatinDRUG

After SRP, Atorvastatin gel was delivered subgingivally into the pocket

SRP and AlendronateDRUG

After SRP, Alendronate gel was delivered subgingivally into the pocket

Eligibility

Sex: ALLMin age: 30 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Baseline to 6 months and Baseline to 9 months

Secondary Outcomes

Plaque index

Plaque index will be measured at 3, 6 and 9 months

Time frame: 3,6 and 9 months

Modified sulcus bleeding index

Modified sulcus bleeding index will be measured at 3, 6 and 9 months

Time frame: 3,6 and 9 months]

Probing pocket depth

Probing pocket depth will be measured at 3, 6 and 9 months

Time frame: 3,6 and 9 months]

Clinical attachment level

Clinical attachment level will be measured at 3, 6 and 9 months

Time frame: 3,6 and 9 months]

Data from ClinicalTrials.gov

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