Comparison of Alendronate With Atorvastatin in Chronic Periodontitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Placebo group

SRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket

Group Type PLACEBO_COMPARATOR

SRP and Placebo gel

Intervention Type DRUG

After SRP, placebo gel was delivered subgingivally into the pocket

Atorvastatin group

SRP plus Atorvastatin SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally

Group Type ACTIVE_COMPARATOR

SRP and Atorvastatin

Intervention Type DRUG

After SRP, Atorvastatin gel was delivered subgingivally into the pocket

Alendronate Group

Alendronate SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally

Group Type ACTIVE_COMPARATOR

SRP and Alendronate

Intervention Type DRUG

After SRP, Alendronate gel was delivered subgingivally into the pocket

Interventions

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SRP and Placebo gel

After SRP, placebo gel was delivered subgingivally into the pocket

Intervention Type DRUG

SRP and Atorvastatin

After SRP, Atorvastatin gel was delivered subgingivally into the pocket

Intervention Type DRUG

SRP and Alendronate

After SRP, Alendronate gel was delivered subgingivally into the pocket

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes