Local 1% metformin gel to improve dental implant stability and peri-implant bone density
Effect of Local Application of 1% Metformin Gel on Implant Stability and Peri-implant Bone Density: A Randomized Controlled Clinical Study
This trial will test whether applying 1% metformin gel at the implant site helps people receiving dental implants achieve stronger implants and denser bone around them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Baghdad Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Baghdad, Baghdad Governorate) |
| Trial ID | NCT07497568 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial that will enroll adults needing single dental implants and randomly assign them to standard implant placement with or without local 1% metformin gel applied at the site. Implant stability will be measured over time using resonance frequency analysis (RFA), and peri-implant bone density will be measured by cone beam CT (CBCT). Clinical and radiographic data will be collected at defined postoperative visits and compared between the two groups. The study aims to determine whether local metformin enhances early osseointegration and peri-implant bone healing.
Who should consider this trial
Good fit: Adults aged 18 or older with bounded partial edentulism who need a dental implant, have adequate bone volume (at least ~5 mm width and 10 mm height), can tolerate conventional surgery, and are willing to consent and attend follow-up visits are ideal candidates.
Not a fit: Patients with active infection or inflammation at the implant site, uncontrolled systemic disease, recent tooth extraction at the site (<6 months), prior bone grafting or soft tissue procedures there, or a history of chemotherapy/radiotherapy are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the approach could improve early implant stability and peri-implant bone healing, potentially lowering the risk of implant failure and improving long-term outcomes.
How similar studies have performed: Preclinical studies and limited small clinical reports suggest local metformin can enhance bone formation and osseointegration, but large randomized trials are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Baghdad, Baghdad Governorate
- University of Baghdad -Collage of Dentistry — Baghdad, Baghdad Governorate, Iraq (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.