Effect of Local Application of 1% Metformin Gel on Implant Stability and Peri-implant Bone Density: A Randomized Controlled Study

March 23, 2026 updated by: Ghada Kareem, University of Baghdad

Effect of Local Application of 1% Metformin Gel on Implant Stability and Peri-implant Bone Density: A Randomized Controlled Clinical Study

This randomized controlled clinical study aims to evaluate the effect of local application of 1% metformin gel on implant stability and peri-implant bone density. Patients requiring dental implants will be randomly allocated into two groups: a control group and a test group receiving metformin gel. Implant stability will be assessed using resonance frequency analysis, and bone density will be evaluated using CBCT imaging. The outcomes will be compared over a follow-up period to determine the effectiveness of metformin in enhancing osseointegration

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed as a randomized controlled clinical trial to investigate the effect of locally applied 1% metformin gel on implant stability and peri-implant bone density. The study will include patients requiring dental implant placement, who will be allocated into two groups: a control group receiving conventional implant placement and a test group receiving additional local application of metformin gel at the implant site.

The primary objective is to evaluate whether metformin enhances implant stability and supports osseointegration. Implant stability will be assessed at different time points using resonance frequency analysis (RFA), while peri-implant bone density changes will be evaluated radiographically using cone beam computed tomography (CBCT).

Patients will be followed over a defined postoperative period, and clinical as well as radiographic data will be collected and analyzed to compare outcomes between the two groups. The findings of this study may provide insight into the potential role of metformin as an adjunctive material in improving implant success and bone healing

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1) Patients age at least 18 years old. 2) Patient with partial edentulous teeth bounded areas that need dental implant for teeth replacement.

    3) Adequate bone volume for implant placement (at least 5 mm width - 10 mm height).

    4) Ability to tolerate conventional surgical and restorative procedures. 5) Patients who are willing to comply the study and give their consent.

Exclusion Criteria:

- 1) Active infection or inflammation in the implant zone. 2) Presence of any uncontrolled systemic diseases. 3) Patient with history of chemotherapy or radiotherapy. 4) Patient had undergone bone grafting and soft tissue procedures prior to implant surgery.

5) Patient had undergone tooth extraction at the implant site less than 6 months prior to implant surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: arm 1 Study group A
Participants receive local application of 1% metformin gel in the implant osteotomy site immediately prior to implant placement. Implant stability and peri-implant bone density will be assessed during the follow-up period.
Drug: Metformin gel, 1%
A 1% metformin gel is locally applied directly into the implant osteotomy site immediately prior to implant placement. The gel is confined to the surgical site and is not systemically administered. This protocol is designed to evaluate the localized effect of metformin on implant stability and peri-implant bone density during the healing period.
Active Comparator: arm 2 Control group B
Participants undergo standard implant placement without any local pharmacological application in the osteotomy site. Implant stability and peri-implant bone density will be assessed during the same follow-up period.
Other: Standard Implant Placement
Implant placement performed following the standard surgical protocol without any local pharmacological application in the osteotomy site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri implant bone density
Time Frame: baseline ( immediately after implant placement ) and three months postoperatively.
Peri-implant bone density will be evaluated using Cone Beam Computed Tomography (CBCT).
baseline ( immediately after implant placement ) and three months postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
implant stability
Time Frame: immediately after implant placement,6 weeks, and 3 months postoperatively.
Implant stability will be assessed using resonance frequency analysis (RFA) and expressed as Implant Stability Quotient (ISQ) values. Measurements will be taken at baseline, immediately after implant placement ,6 weeks, and 3 months postoperatively.
immediately after implant placement,6 weeks, and 3 months postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

March 9, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MSc-OMS-UOB-2025-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because the study involves clinical surgical procedures and patient privacy must be strictly protected. Data generated from this study will be reported in aggregate form only.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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