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Locally Delivered 1% Metformin Gel in the Treatment of Intrabony Defects in Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT02048761
Recruitment Status : Unknown
Verified February 2014 by Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore.
Recruitment status was:  Active, not recruiting
First Posted : January 29, 2014
Last Update Posted : March 3, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

Brief Summary:
This study was designed as a randomized, controlled clinical trial to evaluate the efficacy of 1% MF gel as local drug delivery in adjunct to SRP for the treatment of intrabony defects in chronic periodontitis in comparison with placebo gel.

Condition or disease Intervention/treatment Phase
Intrabony Defects in Chronic Periodontitis Drug: Placebo gel Drug: 1 % Metformin gel Phase 2

Detailed Description:

Background: Metformin (MF) belonging to the class biguanide, is a first-line therapy for type 2 diabetes mellitus, and is one of the most commonly prescribed oral hypoglycemic drug worldwide. MF has shown to posses bone forming and bone sparring actions. The present study was designed to investigate effectiveness of MF, 1 % in an indigenously prepared biodegradable controlled-release gel as, as an adjunct to scaling and root planing (SRP) in treatment of chronic periodontitis subjects with intrabony defects.

Materials and Methods: Sixty five subjects were categorized into two treatment groups: SRP plus 1% MF and SRP plus placebo. Clinical parameters were recorded at baseline and at 3 and 6 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and clinical attachment level (CAL). At baseline and after 6 months, radiologic assessment of intrabony defect (IBD) fill was done using computer-aided software.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Locally Delivered 1% Metformin Gel in the Treatment of Intrabony Defects in Subjects With Chronic Periodontitis : A Randomized Controlled Clinical Trial
Study Start Date : August 2013
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Group
After debridement, placebo gel was applied into the periodontal pockets with a syringe and a blunt canula.
Drug: Placebo gel
After debridement, a single dose of the placebo gel was applied into the periodontal pockets with a syringe and a blunt canula

Active Comparator: 1% Metformin
After debridement, 1% Metformin gel was applied into the periodontal pockets with a syringe and a blunt canula.
Drug: 1 % Metformin gel
After debridement, 1% Metformin gel gel was applied into the periodontal pockets with a syringe and a blunt canula.




Primary Outcome Measures :
  1. Defect depth reduction [ Time Frame: Baseline to 6 months ]
    The primary outcome of the study is to determine the defect depth reduction by 1% metformin gel radio-graphically and compare the outcome with control group.


Secondary Outcome Measures :
  1. Probing depth [ Time Frame: Baseline to 6 months ]
    Probing depth is measured from baseline to 3 months and 6 months in both control and test group.

  2. Clinical attachment level [ Time Frame: Baseline to 6 months ]
    Clinical attachment level is measured from baseline to 3 months and 6 months in both control and test group.

  3. Modified sulcular bleeding index [ Time Frame: Baseline to 6 months ]
    Modified sulcular bleeding index is measured from baseline to 3 months and 6 months in both control and test group.

  4. Plaque index [ Time Frame: Baseline to 6 months ]
    Full mouth and site specific plaque index is measured from baseline to 3 months and 6 months in both control and test group.



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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Systemically healthy subjects
  • Sites with probing depth (PD) ≥5 mm
  • Clinical attachment level (CAL) ≥4 mm
  • Vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included

Exclusion Criteria:

  • Patients with known systemic disease
  • Known or suspected allergy to the MF/ biguanide group
  • Patients on systemic MF or other oral antidiabetic therapy
  • Patients with aggressive periodontitis
  • Patients with diabetes
  • Use of tobacco in any form
  • Alcoholism
  • Immunocompromised patients
  • Pregnant or lactating females

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02048761


Locations
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India
Government Dental College and Research Institute
Bangalore, Karnataka, India, 560002
Sponsors and Collaborators
Government Dental College and Research Institute, Bangalore
Investigators
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Principal Investigator: A R Pradeep, M.D.S. Govt Dental College & Research Inst, Bangalore.

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Responsible Party: Dr. A R Pradeep, Professor, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT02048761     History of Changes
Other Study ID Numbers: GDCRI/ACM/PG/PhD/2013-14/B
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: March 3, 2014
Last Verified: February 2014

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