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

NCT07497568 | Recruiting

• 1 other identifier: MSc-OMS-UOB-2025-1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Implant; Stability

Keywords

dental implant; CBCT; Metformin; bone density; RFA

Outcome Measures

Primary Outcomes (1)

• Peri implant bone density

  Peri-implant bone density will be evaluated using Cone Beam Computed Tomography (CBCT).

  baseline ( immediately after implant placement ) and three months postoperatively.

Secondary Outcomes (1)

• implant stability

  immediately after implant placement,6 weeks, and 3 months postoperatively.

Study Arms (2)

arm 1 Study group A

EXPERIMENTAL

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%

arm 2 Control group B

ACTIVE COMPARATOR

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

Interventions

Metformin gel, 1% DRUG

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.

arm 1 Study group A

Standard Implant Placement OTHER

Implant placement performed following the standard surgical protocol without any local pharmacological application in the osteotomy site.

arm 2 Control group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Patients age at least 18 years old. 2) Patient with partial edentulous teeth bounded areas that need dental implant for teeth replacement.
• \) Adequate bone volume for implant placement (at least 5 mm width - 10 mm height).
• \) Ability to tolerate conventional surgical and restorative procedures. 5) Patients who are willing to comply the study and give their consent.

You may not qualify if:

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

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

University of Baghdad -Collage of Dentistry

Baghdad, Baghdad Governorate, 10001, Iraq

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study with no blinding of participants or investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc student, Department of Oral and Maxillofacial surgery

Model Details: Participants will be randomly assigned into two parallel groups: a control group receiving conventional implant placement and a test group receiving local application of 1% metformin gel.

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): March 9, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)