Alendronate Compared to Metformin in Chronic Periodontitis

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461667
• Other study ID #: GDCRI/ACM/PG/PhD/2/2013-2014G
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 19, 2015
• Last updated: May 31, 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

This is a 9 month randomised controlled clinical comparing the clinical efficacy of 1%metformin and 1%alendronate in chronic periodontitis subjects.

Description:

ABSTRACT Background: Since Metformin (MF) induces osteoblast growth and differentiation while Alendronate (ALN) act as an antiosteolytic agent. The aim of the present study is to evaluate and compare the efficacy of 1% ALN and 1% MF gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of intrabony defects in patients with chronic periodontitis.

Methods:

The study had 3 groups comprising of ninety subjects, divided into three groups 1% MF with SRP, 1% ALN with SRP and placebo gel with SRP. Clinical parameters (plaque index (PI), modified sulcus bleeding index (mSBI), probing pocket depth (PPD), 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: 108
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

• All the subjects were systemically healthy

• subjects with sites having CAL = 3 mm, PPD = 5 mm,

• vertical bone loss = 3 mm on intraoral periapical radiographs (IOPA) and

• subjects with no history of periodontal intervention in the last 6 months.

Exclusion Criteria:

• patients with systemic diseases like cardiovascular disease

• diabetes or HIV infection or on medications like corticosteroids which may impede the healing in periodontal tissues.

• pregnant/lactating females

• tobacco users

• alcoholics

• patients with unsatisfactory oral hygiene (plaque index greater than 1.5)

• teeth having gingival recession, caries involving pulp, intrabony defect present interproximally, grade 2/3 mobility

• Furthermore, patients allergic to Metformin and alendronate or those taking Metformin and alendronate systemically were excluded.

Study Design

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• SRP plus Placebo Gel
After SRP, placebo gel was delivered subgingivally into the pocket
• SRP plus Alendronate gel
Alendronate (ALN) After SRP, ALN gel was delivered subgingivally into the pocket
• SRP plus Metformin gel
Metformin (MF) After SRP, MF 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	bone fill	amount of bone fill from baseline to 9 months	baseline to 9 months	Yes
Secondary	Relative vertical clinical attachment level	change in Relative vertical clinical attachment level baseline to 9 months	baseline to 9 months	Yes
Secondary	probing depth	change in probing depth from baseline to 9 months	baseline to 9 months	Yes