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Alendronate Compared to Metformin in Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT02461667
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

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

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: SRP plus Placebo Gel Drug: SRP plus Alendronate gel Drug: SRP plus Metformin gel Phase 2 Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: placebo
SRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket
Drug: SRP plus Placebo Gel
After SRP, placebo gel was delivered subgingivally into the pocket
Other Name: Placebo

Active Comparator: Metformin
SRP plus Metformin SRP was done for all the subjects. metformin was delivered in the pocket subgingivally
Drug: SRP plus Metformin gel
Metformin (MF) After SRP, MF gel was delivered subgingivally into the pocket
Other Name: Metformin gel

Active Comparator: Alendronate
SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally
Drug: SRP plus Alendronate gel
Alendronate (ALN) After SRP, ALN gel was delivered subgingivally into the pocket
Other Name: Alendronate gel




Primary Outcome Measures :
  1. bone fill [ Time Frame: baseline to 9 months ]
    amount of bone fill from baseline to 9 months


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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Responsible Party: Dr. A R Pradeep, Professor and head, Dept. of Periodontology, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT02461667     History of Changes
Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2013-2014G
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: May 2015

Keywords provided by Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore:
alendronate, metformin

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Metformin
Alendronate
Hypoglycemic Agents
Physiological Effects of Drugs
Bone Density Conservation Agents