Alendronate Compared to Metformin in Chronic Periodontitis

NCT ID: NCT02461667

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-03-31

Brief Summary

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

Detailed 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

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

placebo

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

Group Type: PLACEBO_COMPARATOR

SRP plus Placebo Gel

Intervention Type: DRUG

After SRP, placebo gel was delivered subgingivally into the pocket

Metformin

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

Group Type: ACTIVE_COMPARATOR

SRP plus Metformin gel

Intervention Type: DRUG

Metformin (MF) After SRP, MF gel was delivered subgingivally into the pocket

Alendronate

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

Group Type: ACTIVE_COMPARATOR

SRP plus Alendronate gel

Intervention Type: DRUG

Alendronate (ALN) After SRP, ALN gel was delivered subgingivally into the pocket

Interventions

SRP plus Placebo Gel

After SRP, placebo gel was delivered subgingivally into the pocket

Intervention Type: DRUG

SRP plus Alendronate gel

Alendronate (ALN) After SRP, ALN gel was delivered subgingivally into the pocket

Intervention Type: DRUG

SRP plus Metformin gel

Metformin (MF) After SRP, MF gel was delivered subgingivally into the pocket

Intervention Type: DRUG

Other Intervention Names

Placebo; Alendronate gel; Metformin gel

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Government Dental College and Research Institute, Bangalore

OTHER

Sponsor Role: lead

Responsible Party

Dr. A R Pradeep

Professor and head, Dept. of Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id