Metformin GelNCT07469254
Adding 1% Metformin Gel to Bone Graft in Association With Immediate Dental Implants
A study testing Metformin gel-xenograft and Xenograft in people with Metformin Gel and Bone Graft, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study aimed to investigate whether combining xenografts with Metformin Gel gel enhances bone regeneration and improves implant outcomes. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Metformin Gel, Bone Graft, Immediate Dental Implants
- What is being tested?
- Metformin gel-xenograft and Xenograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Sep 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Metformin Gel, Bone Graft, Immediate Dental Implants
- Being tested
- Metformin gel-xenograft, Xenograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin gel-xenograftOther
Patients received immediate implant combined with a mixture of 1%metformin gel and xenograft.
XenograftOther
Patients received immediate implant combined with xenograft alone.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Patients received immediate implant combined with a mixture of 1%metformin gel and xenograft. Receives: Other: Metformin gel-xenograft |
| Group II | Experimental | Patients received immediate implant combined with xenograft alone. Receives: Other: Xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Implant primary stability
Implant primary stability was assessed using Resonance Frequency Analysis at baseline and at 3, 6, and 12 months after implant placement.
Measured: 12 months after implant placement
Secondary outcomes (6)
Soft tissue change of modified Plaque Iindex
Soft tissue change of modified Plaque Iindex (mPI) was done at baseline and 3, 6 and 12 months after implant placement
Measured: 12 months after implant placement
Soft tissue change of modified sulcus bleeding index
Soft tissue change of modified sulcus bleeding index was done at baseline and 3, 6 and 12 months after implant placement
Measured: 12 months after implant placement
Soft tissue change of peri-implant probing depth
Soft tissue change of peri-implant probing depth (PPD) was done at baseline and 3, 6 and 12 months after implant placement
Measured: 12 months after implant placement
Radiographic Evaluation to horizontal jumping gap
Radiographic Evaluation to horizontal jumping gap using CBCT was done at baseline and 6 and 12 months after implant insertion
Measured: 12 months after implant insertion
Radiographic Evaluation to buccal bone thickness
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
Measured: 12 months after implant insertion
Biochemical assessment of peri-implant crevecular fluid level
Biochemical assessment of peri-implant crevecular fluid level of osteopontin by ELISA was done at basline,1week; and 3 months after implant placement.
Measured: 3 months after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Nov 2022
- Primary completion1 Sep 2025
- Study completion1 Sep 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Gamal Abd El Wahab, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469254
- Sponsor's protocol ID
- AUAREC20220110-02
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Adding 1% Metformin Gel to Bone Graft in Association With Immediate Dental Implants
- ClinicalTrials.gov ID
- NCT07469254
- Acronym / sponsor ID
- AUAREC20220110-02
- Conditions
- Metformin Gel, Bone Graft, Immediate Dental Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 13 Mar 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.
This study aimed to investigate whether combining xenografts with Metformin Gel gel enhances bone regeneration and improves implant outcomes.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Metformin gel-xenograftPatients received immediate implant combined with a mixture of 1%metformin gel and xenograft. |
| Group II | Experimental | Other: XenograftPatients received immediate implant combined with xenograft alone. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 gel-xenograftPatients received immediate implant combined with a mixture of 1%metformin gel and xenograft. | Other | Group I |
| XenograftPatients received immediate implant combined with xenograft alone. | Other | Group II |
Primary outcome
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.
6 secondary outcomes
Soft tissue change of modified Plaque Iindex
Time frame: 12 months after implant placement
Soft tissue change of modified sulcus bleeding index
Time frame: 12 months after implant placement
Soft tissue change of peri-implant probing depth
Time frame: 12 months after implant placement
Radiographic Evaluation to horizontal jumping gap
Time frame: 12 months after implant insertion
Radiographic Evaluation to buccal bone thickness
Time frame: 12 months after implant insertion
Biochemical assessment of peri-implant crevecular fluid level
Time frame: 3 months after implant placement
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 13 Mar 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Metformin Gel
Not yet recruiting
Osteogenic Potential of Topical Metformin Gel on Cystic Jaw Defects
Jaw Cysts, Metformin
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Clinical and Radiographic Evaluation of Subgingival 1% Metformin Gel Versus 0.05% Zoledronate Gel as an Adjunct to MINST of Intrabony Defects in Controlled Type 2 DM
Controlled Type 2 Diabetic Patients With Periodontitis
Recruiting
Effect of Local Application of 1% Metformin Gel on Implant Stability and Peri-implant Bone Density: A Randomized Controlled Study
Dental Implant, Stability
Not yet recruitingPhase 3
Effect of Metformin Iontophoresis on Knee Osteoarthritis in Postmenopausal Women
Osteoarthritis in Postmenopausal Women
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Metformin Versus Chlorhexidine Gel as Adjuncts to Scaling and Root Planing in Stage II Grade B Periodontitis
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin gel-xenograft and Xenograft in people with Metformin Gel and Bone Graft, run by Al-Azhar University at 1 site 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 6 inclusion and 6 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 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Assessment of Implant primary stability (time frame: 12 months after implant placement). 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 13 Mar 2026.