Metformin GelMET-GBRNCT07770087
Effect of Metformin Gel on Guided Bone Regeneration Around Immediate Dental Implant at Posterior Maxillary Region
A study testing Metformin 1% Topical Gel and immediate Dental Implant Placement With Guided Bone Regeneration in people with Metformin Gel and Bone Healing, run by Al-Azhar University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Metformin Gel, Bone Healing, Guided Bone Regeneration
- What is being tested?
- Metformin 1% Topical Gel and immediate Dental Implant Placement With Guided Bone Regeneration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Nov 2022to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. All patients were free from any systemic diseases according to criteria of Cornell Medical Index and its modification(184).
- 2. 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.
- 4. Extraction socket has sufficient bone quality and quantity amenable for implant length that is not less than 10 mm and of suitable diameter.
- 5. The implant recipient site should be free from any pathological conditions. 6. Patients with Good Oral Hygiene, and instructed for oral hygiene measures
Who cannot join
- 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.
- 7. Any medicines such as bisphosphonates or steroids that affect bone turn over.
- 8. History of chemotherapy or radiotherapy.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Dental Medicine, Al-Azhar University, Assiut Branch
Asyut, Assiut Governorate, 71511
Department of Oral and Maxillofacial Surgery, Faculty of Dental Medicine, Al-Azhar University, Assiut Branch
Asyut
About this study
Official title: Evaluation of the Efficacy of Metformin Topical Application on Bone Healing Around Immediate Dental Implants
To evaluate, by standardized radiographic follow-up, whether locally delivered 1% metformin gel improves bone healing around immediately placed dental implants augmented with GBR.
Read the detailed description
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.
- Conditions
- Metformin Gel, Bone Healing, Guided Bone Regeneration, Crestal Bone Loss, Peri Implant Bone Loss
- Being tested
- Metformin 1% Topical Gel, immediate Dental Implant Placement With Guided Bone Regeneration
- Keywords
- Metformin Gel, Guided Bone Regeneration, Immediate Dental Implant, Posterior Maxilla, Peri-implant Bone Density, Crestal Bone Loss, Bone Regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin 1% Topical GelDrug
Also called Topical Metformin Gel
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.
immediate Dental Implant Placement With Guided Bone RegenerationProcedure or surgery
Also called Immediate Implant Placement With GBR
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: immediate Dental Implant Placement With Guided Bone Regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (immediately after implant placement) , 6 months, and 12 months.
Secondary outcomes (1)
Change in Crestal Bone Level
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.
Measured: Baseline (immediately after implant placement) and 6, 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Nov 2022
- Primary completion15 Nov 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metformin GelStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kariman Mohamed Ebeid, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770087
- Sponsor's protocol ID
- AUAREC2022011-5
- Acronym
- MET-GBR
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no data-sharing plan was included in the original study protocol or ethics approval, and participant confidentiality must be maintained.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Metformin Topical Application on Bone Healing Around Immediate Dental Implants
- ClinicalTrials.gov ID
- NCT07770087
- Acronym / sponsor ID
- MET-GBR / AUAREC2022011-5
- Conditions
- Metformin Gel, Bone Healing, Guided Bone Regeneration, Crestal Bone Loss, Peri Implant Bone Loss
- Keywords
- Metformin Gel, Guided Bone Regeneration, Immediate Dental Implant, Posterior Maxilla, Peri-implant Bone Density, Crestal Bone Loss, Bone Regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate, by standardized radiographic follow-up, whether locally delivered 1% metformin gel improves bone healing around immediately placed dental implants augmented with GBR.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: Metformin 1% Topical GelParticipants 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. |
| control group | Experimental | Procedure: immediate Dental Implant Placement With Guided Bone RegenerationParticipants received immediate dental implant placement with guided bone regeneration using the same alloplastic bone graft and collagen membrane protocol, without topical metformin gel. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1. All patients were free from any systemic diseases according to criteria of Cornell Medical Index and its modification(184).
- 2. 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.
- 4. Extraction socket has sufficient bone quality and quantity amenable for implant length that is not less than 10 mm and of suitable diameter.
- 5. The implant recipient site should be free from any pathological conditions. 6. Patients with Good Oral Hygiene, and instructed for oral hygiene measures
Key exclusion criteria (3 listed)
- 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.
- 7. Any medicines such as bisphosphonates or steroids that affect bone turn over.
- 8. History of chemotherapy or radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin 1% Topical GelAlso: Topical Metformin GelA 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. | Drug | study group |
| immediate Dental Implant Placement With Guided Bone RegenerationAlso: Immediate Implant Placement With GBRImmediate 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. | Procedure or surgery | control group |
Primary outcome
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.
1 secondary outcome
Change in Crestal Bone Level
Time frame: Baseline (immediately after implant placement) and 6, 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no data-sharing plan was included in the original study protocol or ethics approval, and participant confidentiality must be maintained.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin 1% Topical Gel and immediate Dental Implant Placement With Guided Bone Regeneration in people with Metformin Gel and Bone Healing, run by Al-Azhar University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implant Bone Density (time frame: Baseline (immediately after implant placement) , 6 months, and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.