Alendronate Compared to Metformin in Chronic Periodontitis
Information source: Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Periodontitis
Intervention: SRP plus Placebo Gel (Drug); SRP plus Alendronate gel (Drug); SRP plus Metformin gel (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Government Dental College and Research Institute, Bangalore
Summary
This is a 9 month randomised controlled clinical comparing the clinical efficacy of
1%metformin and 1%alendronate in chronic periodontitis subjects.
Clinical Details
Official title: Comparative Evaluation of Subgingivally Delivered 1% Metformin and 1% Alendronate Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: bone fill
Secondary outcome: Relative vertical clinical attachment levelprobing depth
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
Eligibility
Minimum age: 25 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: July 2014
Last updated: May 31, 2015
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