Dental ImplantNCT07497568
Effect of Local Application of 1% Metformin Gel on Implant Stability and Peri-implant Bone Density: A Randomized Controlled Study
A study testing Metformin gel, 1% and Standard Implant Placement in people with Dental Implant and Stability, run by University of Baghdad at 1 site in Iraq.
Trial summary
This randomized controlled clinical study aims to evaluate the effect of local application of 1% metformin gel on implant stability and peri-implant bone density. Patients requiring dental implants will be randomly allocated into two groups: a control group and a test group receiving metformin gel. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dental Implant, Stability
- What is being tested?
- Metformin gel, 1% and Standard Implant Placement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIraq
- Study dates
- 1 Nov 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Patients age at least 18 years old. 2) Patient with partial edentulous teeth bounded areas that need dental implant for teeth replacement.
- 3) Adequate bone volume for implant placement (at least 5 mm width - 10 mm height).
- 4) Ability to tolerate conventional surgical and restorative procedures. 5) Patients who are willing to comply the study and give their consent.
Who cannot join
- 1) Active infection or inflammation in the implant zone. 2) Presence of any uncontrolled systemic diseases. 3) Patient with history of chemotherapy or radiotherapy. 4) Patient had undergone bone grafting and soft tissue procedures prior to implant surgery.
- 5) Patient had undergone tooth extraction at the implant site less than 6 months prior to implant surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site, 1 recruiting
- Recruiting
University of Baghdad -Collage of Dentistry
Baghdad, Baghdad Governorate, 10001
Ghadah Kareem M.S.c. Candidate, B.D.S., +9647736704817, ghada.Obaid2408m@codental.uobaghdad.edu.iq
jubori, B.D.S., +9647736704817, ghada.Obaid2408m@codental.uobaghdad.edu.iq
About this study
Official title: Effect of Local Application of 1% Metformin Gel on Implant Stability and Peri-implant Bone Density: A Randomized Controlled Clinical Study
This randomized controlled clinical study aims to evaluate the effect of local application of 1% metformin gel on implant stability and peri-implant bone density. Patients requiring dental implants will be randomly allocated into two groups: a control group and a test group receiving metformin gel. Implant stability will be assessed using resonance frequency analysis, and bone density will be evaluated using CBCT imaging. The outcomes will be compared over a follow-up period to determine the effectiveness of metformin in enhancing osseointegration
Read the detailed description
This study is designed as a randomized controlled clinical trial to investigate the effect of locally applied 1% metformin gel on implant stability and peri-implant bone density. The study will include patients requiring dental implant placement, who will be allocated into two groups: a control group receiving conventional implant placement and a test group receiving additional local application of metformin gel at the implant site.
The primary objective is to evaluate whether metformin enhances implant stability and supports osseointegration. Implant stability will be assessed at different time points using resonance frequency analysis (RFA), while peri-implant bone density changes will be evaluated radiographically using cone beam computed tomography (CBCT).
Patients will be followed over a defined postoperative period, and clinical as well as radiographic data will be collected and analyzed to compare outcomes between the two groups. The findings of this study may provide insight into the potential role of metformin as an adjunctive material in improving implant success and bone healing
- Conditions
- Dental Implant, Stability
- Being tested
- Metformin gel, 1%, Standard Implant Placement
- Keywords
- dental implant, CBCT, Metformin, bone density, RFA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin gel, 1%Drug
A 1% metformin gel is locally applied directly into the implant osteotomy site immediately prior to implant placement. The gel is confined to the surgical site and is not systemically administered. This protocol is designed to evaluate the localized effect of metformin on implant stability and peri-implant bone density during the healing period.
Standard Implant PlacementOther
Implant placement performed following the standard surgical protocol without any local pharmacological application in the osteotomy site.
| Study group | Role | What they receive |
|---|---|---|
| arm 1 Study group A | Experimental | Participants receive local application of 1% metformin gel in the implant osteotomy site immediately prior to implant placement. Implant stability and peri-implant bone density will be assessed during the follow-up period. Receives: Drug: Metformin gel, 1% |
| arm 2 Control group B | Active comparator | Participants undergo standard implant placement without any local pharmacological application in the osteotomy site. Implant stability and peri-implant bone density will be assessed during the same follow-up period. Receives: Other: Standard Implant Placement |
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 will be evaluated using Cone Beam Computed Tomography (CBCT).
Measured: baseline ( immediately after implant placement ) and three months postoperatively.
Secondary outcomes (1)
implant stability
Implant stability will be assessed using resonance frequency analysis (RFA) and expressed as Implant Stability Quotient (ISQ) values. Measurements will be taken at baseline, immediately after implant placement ,6 weeks, and 3 months postoperatively.
Measured: immediately after implant placement,6 weeks, and 3 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Nov 2025
- Primary completion9 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- Model description
- Participants will be randomly assigned into two parallel groups: a control group receiving conventional implant placement and a test group receiving local application of 1% metformin gel.
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Kareem, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497568
- Sponsor's protocol ID
- MSc-OMS-UOB-2025-1
- Status last verified
- Feb 2026
- First submitted
- 23 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study involves clinical surgical procedures and patient privacy must be strictly protected. Data generated from this study will be reported in aggregate form only.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Application of 1% Metformin Gel on Implant Stability and Peri-implant Bone Density: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07497568
- Acronym / sponsor ID
- MSc-OMS-UOB-2025-1
- Conditions
- Dental Implant, Stability
- Keywords
- dental implant, CBCT, Metformin, bone density, RFA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 9 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 27 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 randomized controlled clinical study aims to evaluate the effect of local application of 1% metformin gel on implant stability and peri-implant bone density. Patients requiring dental implants will be randomly allocated into two groups: a control group and a test group receiving metformin gel. Implant stability will be assessed using resonance frequency analysis, and bone density will be evaluated using CBCT imaging. The outcomes will be compared over a follow-up period to determine the effectiveness of metformin in enhancing osseointegration
Detailed description
This study is designed as a randomized controlled clinical trial to investigate the effect of locally applied 1% metformin gel on implant stability and peri-implant bone density. The study will include patients requiring dental implant placement, who will be allocated into two groups: a control group receiving conventional implant placement and a test group receiving additional local application of metformin gel at the implant site.
The primary objective is to evaluate whether metformin enhances implant stability and supports osseointegration. Implant stability will be assessed at different time points using resonance frequency analysis (RFA), while peri-implant bone density changes will be evaluated radiographically using cone beam computed tomography (CBCT).
Patients will be followed over a defined postoperative period, and clinical as well as radiographic data will be collected and analyzed to compare outcomes between the two groups. The findings of this study may provide insight into the potential role of metformin as an adjunctive material in improving implant success and bone healing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned into two parallel groups: a control group receiving conventional implant placement and a test group receiving local application of 1% metformin gel.
| Arm | Type | Receives |
|---|---|---|
| arm 1 Study group A | Experimental | Drug: Metformin gel, 1%Participants receive local application of 1% metformin gel in the implant osteotomy site immediately prior to implant placement. Implant stability and peri-implant bone density will be assessed during the follow-up period. |
| arm 2 Control group B | Active comparator | Other: Standard Implant PlacementParticipants undergo standard implant placement without any local pharmacological application in the osteotomy site. Implant stability and peri-implant bone density will be assessed during the same follow-up period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1) Patients age at least 18 years old. 2) Patient with partial edentulous teeth bounded areas that need dental implant for teeth replacement.
- 3) Adequate bone volume for implant placement (at least 5 mm width - 10 mm height).
- 4) Ability to tolerate conventional surgical and restorative procedures. 5) Patients who are willing to comply the study and give their consent.
Key exclusion criteria (2 listed)
- 1) Active infection or inflammation in the implant zone. 2) Presence of any uncontrolled systemic diseases. 3) Patient with history of chemotherapy or radiotherapy. 4) Patient had undergone bone grafting and soft tissue procedures prior to implant surgery.
- 5) Patient had undergone tooth extraction at the implant site less than 6 months prior to implant surgery.
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, 1%A 1% metformin gel is locally applied directly into the implant osteotomy site immediately prior to implant placement. The gel is confined to the surgical site and is not systemically administered. This protocol is designed to evaluate the localized effect of metformin on implant stability and peri-implant bone density during the healing period. | Drug | arm 1 Study group A |
| Standard Implant PlacementImplant placement performed following the standard surgical protocol without any local pharmacological application in the osteotomy site. | Other | arm 2 Control group B |
Primary outcome
Peri implant bone density
Time frame: baseline ( immediately after implant placement ) and three months postoperatively.
Peri-implant bone density will be evaluated using Cone Beam Computed Tomography (CBCT).
1 secondary outcome
implant stability
Time frame: immediately after implant placement,6 weeks, and 3 months postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study involves clinical surgical procedures and patient privacy must be strictly protected. Data generated from this study will be reported in aggregate form only.
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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.
University of Baghdad -Collage of Dentistry
Baghdad, Iraq
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, 1% and Standard Implant Placement in people with Dental Implant and Stability, run by University of Baghdad at 1 site in Iraq.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 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 Iraq. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. 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 ) and three months postoperatively.). 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 27 Mar 2026.