We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 256763 for:    ALL
Previous Study | Return to List | Next Study

Locally Delivered 1% Metformin Gel in Peri-implantitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03312582
First Posted: October 17, 2017
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zohaib Akram, King Saud University
  Purpose
This study evaluates the efficacy of 1% local metformin gel in deep periimplant pockets of type 2 diabetes mellitus patients. Half of the participants will receive 1% metformin gel with manual debridement while the other half will receive a placebo with manual debridement.

Condition Intervention Phase
Peri-Implantitis Drug: 1% local metformin gel Procedure: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Locally Delivered 1% Metformin Gel in the Treatment of Peri-implantitis in Type2 Diabetes Mellitus Patients: A Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Zohaib Akram, King Saud University:

Primary Outcome Measures:
  • Marginal bone loss [ Time Frame: 6 months ]
    Marginal bone loss will be assessed on digital radiographs on calibrated computer screen.

  • Peri-implant prpbing depth [ Time Frame: 6 months ]
    Will be measured with UNC-15 periodontal probe from crest of the gingival margin to the base of the peri-implant probing depth.


Enrollment: 46
Actual Study Start Date: March 15, 2015
Study Completion Date: July 24, 2017
Primary Completion Date: August 14, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Manual debridement and 1% metformin gel Drug: 1% local metformin gel
After providing manual debridement in deep peri-implant probing depths, 1% metformin gel will be applied.
Placebo Comparator: Manual debridement and placebo Procedure: Placebo
Other Name: After providing manual debridement in deep peri-implant probing depths, placebo gel will be applied.

Detailed Description:
Metformin is an oral hypoglycemic drug categorized under biguanide and are considered the most efficient agents widely used in the treatment of type 2 diabetes mellitus.The general clinical benefits observed in therapy with MF seem to be greater than expected. They induce osteoblast cells to promote early bone formation through AMP kinase (AMPK) activity. Moreover, in a recent in vitro study, MF facilitated in the proliferation of MG63 osteoblast like cells. Thus, their action in stimulating bone formation has justified their use in the treatment of perimplantitis.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus patients.
  • Patients with peri-implantitis

Exclusion Criteria:

  • History of any other systemic diseases
  • Cigarette smokers
  • Smokeless tobacco users
  • Patients who underwent scaling in the last 1 year
  • Patients who took antibiotics in tje past 6 months
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Zohaib Akram, Director, Clinical Research, King Saud University
ClinicalTrials.gov Identifier: NCT03312582     History of Changes
Other Study ID Numbers: FR-17-75
First Submitted: October 12, 2017
First Posted: October 17, 2017
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs