Skip to main content
OpenTrials
Completed

NCT Number: NCT07770087

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine, Al-Azhar University, Assiut Branch, Asyut, Assiut Governorate, Egypt

Loading trial locations.

About this study

Dental implants are now a routine treatment option for replacing missing teeth because they restore masticatory function, preserve adjacent tooth structure, and provide favorable long-term survival when case selection and surgical execution are appropriate . After extraction, however, the alveolar ridge does not remain static. The socket undergoes dimensional remodeling, and this remodeling may affect implant position, emergence profile, soft-tissue contour, and the need for additional augmentation .

Immediate implant placement was introduced to reduce the number of surgical procedures and shorten the total treatment period. When it is performed in a suitable socket, it may also help maintain the peri-implant tissue architecture. The technique is more demanding in the posterior maxilla, where the extraction socket is often wider than the implant diameter and the native bone is commonly less dense than in other regions. These features can make primary stability, gap management, and prosthetically driven positioning more challenging .

The space between the implant surface and the socket wall, often described clinically as the horizontal gap or jumping distance, is a key biological issue in immediate implant therapy. Small gaps surrounded by intact socket walls may heal with little intervention, but wider gaps, thin buccal plates, and deficient low-density bone reduce the predictability of spontaneous bone fill. For this reason, GBR with particulate grafts and resorbable membranes is frequently used to support space maintenance, provide osteoconduction, and restrict soft-tissue invasion during bone repair.

Although GBR provides a useful scaffold for regeneration, the addition of a biologically active agent may enhance the cellular events that drive early osteogenesis, angiogenesis, and mineralization. Metformin, a biguanide drug widely used in type 2 diabetes mellitus, has attracted attention in bone-regeneration research because it can activate AMP-activated protein kinase, improve osteoblastic differentiation, reduce oxidative stress, and influence angiogenic signaling. Local delivery is clinically attractive because it can concentrate the drug at the surgical site while keeping systemic exposure minimal .

The present randomized radiographic study was therefore designed to assess whether topical 1% metformin gel, when used with GBR, improves peri-implant bone healing around immediately placed implants in the posterior maxilla. The extended 12-month analysis was added to explore whether the early radiographic bone-density response observed during osseointegration could be maintained after prosthetic rehabilitation and functional loading.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Topical Metformin Gel

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.

Other names: Immediate Implant Placement With GBR

Primary outcomes

  1. Peri-implant Bone Density

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

    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.

Secondary outcomes

  1. Change in Crestal Bone Level

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

    Crestal bone level around the dental implant was evaluated radiographically using CBCT. The distance between the implant reference point and the adjacent crestal bone level was measured, and changes from baseline to 6 months were compared between the study groups.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Evaluation of the Efficacy of Metformin Topical Application on Bone Healing Around Immediate Dental Implants

Acronym: MET-GBR

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.