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Completed

NCT Number: NCT02461667

Alendronate Compared to Metformin in Chronic Periodontitis

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

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Key information

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SRP plus placebo gel

Drug

After SRP, placebo gel was delivered subgingivally into the pocket

Other names: Placebo

SRP plus Alendronate gel

Drug

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

Other names: Alendronate gel

SRP plus Metformin gel

Drug

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

Other names: Metformin gel

Primary outcomes

  1. bone fill

    Time frame: baseline to 9 months

    amount of bone fill from baseline to 9 months

Secondary outcomes

  1. Relative vertical clinical attachment level

    Time frame: baseline to 9 months

    change in Relative vertical clinical attachment level baseline to 9 months

  2. probing depth

    Time frame: baseline to 9 months

    change in probing depth from baseline to 9 months

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 3, 2015
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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