Alendronate Compared to Metformin in Chronic Periodontitis

Government Dental College and Research Institute, Bangalore

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Periodontitis

Treatments: Drug: SRP plus Alendronate gel; Drug: SRP plus Placebo Gel; Drug: SRP plus Metformin gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02461667

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

Details and patient eligibility

About

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

Full 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

Enrollment: 108 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 3 patient groups, including a placebo group

placebo

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 plus Placebo Gel

Metformin

Active Comparator group

Description:

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

Treatment:

Drug: SRP plus Metformin gel

Alendronate

Active Comparator group

Description:

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

Treatment:

Drug: SRP plus Alendronate gel