NCT07497568

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: University of Baghdad · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

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

Conditions

• Dental Implant
• Stability

Interventions

Type	Name	Description
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.
OTHER	Standard Implant Placement	Implant placement performed following the standard surgical protocol without any local pharmacological application in the osteotomy site.

Timeline

• Start date: 2025-11-01
• Primary completion: 2027-03-09
• Completion: 2027-06-01
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: Iraq