Comparison of Alendronate With Atorvastatin in Chronic Periodontitis

Chronic Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455869
• Other study ID #: GDCRI/ACM/PG/PhD/2/2013-2014J
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 19, 2015
• Last updated: May 25, 2015
• Start date: July 2014
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• SRP and Placebo gel
After SRP, placebo gel was delivered subgingivally into the pocket
• SRP and Atorvastatin
After SRP, Atorvastatin gel was delivered subgingivally into the pocket
• SRP and Alendronate
After SRP, Alendronate gel was delivered subgingivally into the pocket

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Plaque index	Plaque index will be measured at 3, 6 and 9 months	3,6 and 9 months	No
Secondary	Modified sulcus bleeding index	Modified sulcus bleeding index will be measured at 3, 6 and 9 months	3,6 and 9 months]	No
Secondary	Probing pocket depth	Probing pocket depth will be measured at 3, 6 and 9 months	3,6 and 9 months]	No
Secondary	Clinical attachment level	Clinical attachment level will be measured at 3, 6 and 9 months	3,6 and 9 months]	No