Effect of Metformin Gel on Guided Bone Regeneration Around Immediate Dental Implant at Posterior Maxillary Region

NCT07770087 | Completed DMC

• 1 other identifier: AUAREC2022011-5
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate, by standardized radiographic follow-up, whether locally delivered 1% metformin gel improves bone healing around immediately placed dental implants augmented with GBR.

Conditions

Peri Implant Bone Loss; Metformin Gel; Bone Healing; Guided Bone Regeneration; Crestal Bone Loss

Keywords

Metformin Gel; Guided Bone Regeneration; Immediate Dental Implant; Posterior Maxilla; Peri-implant Bone Density; Crestal Bone Loss; Bone Regeneration

Outcome Measures

Primary Outcomes (1)

• Peri-implant Bone Density

  Peri-implant bone density was assessed using cone-beam computed tomography (CBCT). Bone density was measured as the mean gray-scale value within a standardized region of interest adjacent to the dental implant. Changes in peri-implant bone density were compared between the metformin and control groups.

  Baseline (immediately after implant placement) , 6 months, and 12 months.

Secondary Outcomes (1)

• Change in Crestal Bone Level

  Baseline (immediately after implant placement) and 6, 12 months.

Study Arms (2)

study group

EXPERIMENTAL

Participants received immediate dental implant placement with guided bone regeneration using an alloplastic bone graft and collagen membrane, with topical application of 1% metformin gel around the implant.

Drug: Metformin 1% Topical Gel

control group

EXPERIMENTAL

Participants received immediate dental implant placement with guided bone regeneration using the same alloplastic bone graft and collagen membrane protocol, without topical metformin gel.

Procedure: immediate Dental Implant Placement With Guided Bone Regeneration

Interventions

Metformin 1% Topical Gel DRUG

A 1% metformin gel was topically applied around the dental implant at the time of immediate implant placement. The intervention was used in conjunction with guided bone regeneration using an alloplastic bone graft and collagen membrane in the posterior maxillary region.

Also known as: Topical Metformin Gel

study group

immediate Dental Implant Placement With Guided Bone Regeneration PROCEDURE

Immediate dental implant placement was performed following atraumatic extraction in the posterior maxillary region. Guided bone regeneration was performed using an alloplastic bone graft and collagen membrane around the implant. This procedure was performed in both study groups; participants in the control group received this protocol without topical metformin gel.

Also known as: Immediate Implant Placement With GBR

control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. All patients were free from any systemic diseases according to criteria of Cornell Medical Index and its modification(184).
• \. Patent's age at least 18 years old. 3. Patients had remaining roots or badly decayed hopeless teeth indicated for extraction for immediate implant placement in the posterior maxilla region.
• \. Extraction socket has sufficient bone quality and quantity amenable for implant length that is not less than 10 mm and of suitable diameter.
• \. The implant recipient site should be free from any pathological conditions. 6. Patients with Good Oral Hygiene, and instructed for oral hygiene measures

You may not qualify if:

• Patients with bad oral hygiene. 2. Uncontrolled systemic diseases that complicate bone healing. 3. Presence of any pathology in the implant site. 4. Heavy smokers, alcohol or drug abuse patients. 5. Patients with para functional habits such as bruxism and clenching. 6. Conditions that might lead to alteration of bone region as osteoporosis or Paget's disease.
• \. Any medicines such as bisphosphonates or steroids that affect bone turn over.
• \. History of chemotherapy or radiotherapy.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (2)

Faculty of Dental Medicine, Al-Azhar University, Assiut Branch

Asyut, Assiut Governorate, 71511, Egypt

Location

Department of Oral and Maxillofacial Surgery, Faculty of Dental Medicine, Al-Azhar University, Assiut Branch

Asyut, Egypt

Location

MeSH Terms

Interventions

Metformin; Gels

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Researcher, Department of Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 18, 2026
• Study Start: November 1, 2022
• Primary Completion: November 15, 2025
• Study Completion: December 15, 2025
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)