Comparison of Alendronate With Atorvastatin in Chronic Periodontitis

Government Dental College and Research Institute, Bangalore

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Periodontitis

Treatments: Drug: SRP and Atorvastatin; Drug: SRP and Alendronate; Drug: SRP and Placebo gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02455869

GDCRI/ACM/PG/PhD/2/2013-2014J

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 3 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: SRP and Placebo gel

Atorvastatin group

Active Comparator group

Description:

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

Treatment:

Drug: SRP and Atorvastatin

Alendronate Group

Active Comparator group

Description:

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

Treatment:

Drug: SRP and Alendronate