Adding 1% Metformin Gel to Bone Graft in Association With Immediate Dental Implants

March 9, 2026 updated by: Ibrahim Gamal Abd El Wahab, Al-Azhar University

The Impact of Adding 1% Metformin Gel to Bone Graft in Association With Immediate Dental Implants

This study aimed to investigate whether combining xenografts with Metformin Gel gel enhances bone regeneration and improves implant outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The placement of a dental implant in an extraction socket at the time of extraction or explanation is known as immediate implant placement whereas delayed placement of implant signifies the implant placement in edentulous areas where healing has completed with new bone formation after the loss of tooth/teeth.

The xenograft is derived from other organisms, mainly bovine. It provides long-term volume stability. Porous natural hydroxyapatite can be obtained from animal bones.

Metformin HCl (1, 1-dimethylbiguanide HCl) (MF), is one of the most commonly used oral anti-hyperglycemic agents for the treatment of type 2 diabetes mellitus. The use of MF may reduce the association between diabetes and fractures in patients with both type 1 and type 2DM.MF increase type I collagen production in osteoblast-like cell lines and stimulated alkaline phosphate activity in osteoblasts.

Study Type

Interventional

Enrollment (Actual)

20

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

  • Egypt
      • Asyut, Egypt, 71524
        • Al-Azhar University (Assiut)

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age from 18 to 40 years.
  • Both sexes.
  • Adult individual with non-restorable tooth in esthetic and premolars area and seeking for immediate implant placement.
  • Systemically healthy patients were selected for implant surgery according to the criteria of Cornell medical index and its modifications.
  • The recipient site of the implant should be free from any pathological conditions.
  • Sufficient vertical bone height to safely place at least 12 mm long dental implant.

Exclusion Criteria:

  • Smokers.
  • Pregnant or lactating female patients.
  • Patients with parafunctional habits such as bruxism and clenching.
  • Presence of acute infection around the failing tooth.
  • Perforation and/or loss of the labial bony plate following tooth removal and/or implant osteotomy.
  • Inability to attain primary implant stability following immediate implant placement.

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: Group I
Patients received immediate implant combined with a mixture of 1%metformin gel and xenograft.
Other: Metformin gel-xenograft
Patients received immediate implant combined with a mixture of 1%metformin gel and xenograft.
Experimental: Group II
Patients received immediate implant combined with xenograft alone.
Other: Xenograft
Patients received immediate implant combined with xenograft alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Implant primary stability
Time Frame: 12 months after implant placement
Implant primary stability was assessed using Resonance Frequency Analysis at baseline and at 3, 6, and 12 months after implant placement.
12 months after implant placement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft tissue change of modified Plaque Iindex
Time Frame: 12 months after implant placement
Soft tissue change of modified Plaque Iindex (mPI) was done at baseline and 3, 6 and 12 months after implant placement
12 months after implant placement
Soft tissue change of modified sulcus bleeding index
Time Frame: 12 months after implant placement
Soft tissue change of modified sulcus bleeding index was done at baseline and 3, 6 and 12 months after implant placement
12 months after implant placement
Soft tissue change of peri-implant probing depth
Time Frame: 12 months after implant placement
Soft tissue change of peri-implant probing depth (PPD) was done at baseline and 3, 6 and 12 months after implant placement
12 months after implant placement
Radiographic Evaluation to horizontal jumping gap
Time Frame: 12 months after implant insertion
Radiographic Evaluation to horizontal jumping gap using CBCT was done at baseline and 6 and 12 months after implant insertion
12 months after implant insertion
Radiographic Evaluation to buccal bone thickness
Time Frame: 12 months after implant insertion
Radiographic Evaluation to buccal bone thickness using CBCT and vertical marginal bone level and bone density were done at baseline and 6 and 12 months after implant insertion
12 months after implant insertion
Biochemical assessment of peri-implant crevecular fluid level
Time Frame: 3 months after implant placement
Biochemical assessment of peri-implant crevecular fluid level of osteopontin by ELISA was done at basline,1week; and 3 months after implant placement.
3 months after implant placement

Collaborators and Investigators

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

Sponsor

Al-Azhar University

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, 2022

Primary Completion (Actual)

September 1, 2025

Study Completion (Actual)

September 1, 2025

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUAREC20220110-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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