Jaw CystsNCT07867236
Osteogenic Potential of Topical Metformin Gel on Cystic Jaw Defects
A study testing For the Experimental Arm: 1% Metformin Gel in people with Jaw Cysts and Metformin, run by Fayoum University at 1 site in Egypt.
Trial summary
Evaluate the osteogenic effect of locally applied 1% metformin gel on bone volume formation after jaw cystic defects enucleation Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Jaw Cysts, Metformin, Inflammatory Cyst
- What is being tested?
- For the Experimental Arm: 1% Metformin Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2026to 30 Oct 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- o Healthy adults patients .
- Confirmed radiolucent odontogenic cysts requiring enucleation.
- The cystic defect range 5cmto ≤15cm (19)
- Good oral hygiene and strict commitment to attend follow-up scans.
Who cannot join
- o Medically compromised patients
- Heavy smokers (consuming more than 10 cigarettes a day).
- Active, acute purulent infection at the surgical site (this must be resolved before surgery).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Osteogenic Potential of Topical Metformin Gel on Bone Regeneration in Cystic Jaw Defects: Randomized Controlled Clinical Trial
Evaluate the osteogenic effect of locally applied 1% metformin gel on bone volume formation after jaw cystic defects enucleation
Read the detailed description
Odontogenic jaw cysts, represent a significant portion of the pathological lesions encountered in daily oral and maxillofacial surgery. They account for approximately 15% of all oral biopsies and predominantly affect patients in their second to fourth decades of life (1). Following the surgical enucleation of a cyst, a bony defect remains. Traditionally, the standard practice has been to allow this cavity to fill with a blood clot, relying on natural biological processes to eventually form new bone.(2) However, unassisted healing is often unpredictable. The natural healing timeline can be slow, sometimes resulting in the ingrowth of fibrous scar tissue rather than solid bone (3). More importantly, the alveolar ridge often collapses during these prolonged months of healing. This dimensional loss creates a significant rehabilitation problem, particularly if the patient requires a dental implant in the future.(4) Management of the residual dead space following jaw cyst enucleation has been highly debated, with treatment protocols evolving significantly over the past decades. Early approaches relied solely on the spontaneous organization of the blood clot; however, this often leads to soft tissue invagination and incomplete bony contouring in critical-sized defects greater than 3 cm (4,5). To provide structural support, autologous bone grafting became the historical gold standard, though its routine use is now heavily deterred by severe donor-site morbidity and increased surgical time (5). Subsequent shifts toward xenografts and human allografts reduced donor-site risks but presented new challenges, as these materials frequently exhibit unpredictable, prolonged resorption times that impede natural host bone remodeling (6). In recent years, the focus has shifted toward autologous platelet concentrates (such as PRF) and synthetic bioceramics (such as Beta-Tricalcium Phosphate). While PRF is highly osteoinductive; it lacks the mechanical rigidity necessary to prevent tissue collapse in large cystic defects (7). Conversely, bioceramics provide excellent space maintenance, but their inherent high radiopacity, severely confounds early radiographic assessment, making it difficult to distinguish residual graft particles from true new bone formation and mineralization (8). Because current modalities urge for a compromise between mechanical support, predictable resorption, and radiographic clarity; there remains a critical need for a fully radiolucent, bioactive scaffold capable of accelerating bone regeneration.(7) Metformin (1,1-dimethylbiguanide hydrochloride) is an FDA-approved, first-line oral hypoglycemic agent utilized globally for the management of Type II Diabetes Mellitus. However, extensive in vitro and in vivo studies have revealed that Metformin possesses profound, glucose-independent pleiotropic effects on bone metabolism (9). Systemic administration of Metformin has been retrospectively associated with a decreased risk of bone fractures and enhanced bone mineral density in diabetic patients (10).
At the cellular level, Metformin functions as a potent osteoinductive agent primarily through the activation of the AMP-activated protein kinase (AMPK) pathway. Activation of AMPK by Metformin subsequently upregulates the expression of Runt-related transcription factor 2 (Runx2) and Osterix which are the master transcription factors required for the differentiation of mesenchymal stem cells into mature, matrix-producing osteoblasts (9-11). Furthermore, Metformin exerts a dual action by simultaneously inhibiting osteoclastogenesis. It suppresses the Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) expression, thereby reducing bone resorption and shifting the physiological balance toward net bone apposition (11).
In a series of randomized controlled clinical trials focused on periodontal regeneration, Pradeep et al. established that the intra-bony application of 1% Metformin gel resulted in significantly greater probing depth reduction and defect fill compared to placebo gels, confirming its clinical safety and regenerative potential in the alveolar bone (12). Montalbán et al used 1% metformin solution in an animal model of guided bone regeneration with particulate bovine hydroxyapatite and hyaluronate and the results revealed that higher average bone-biomaterial contact percentage was observed in the samples, with metformin in both the proximal and distal regions. (13) By formulating Metformin into a high-viscosity gel and injecting it directly into the surgical defect, the medication blends with the pooling blood. This approach transforms the patient's natural blood clot into an active tissue-engineering matrix. It accelerates bone regeneration and increases bone density, effectively bypassing the need for traditional physical bone grafts(14).
Despite the robust evidence supporting Metformin's osteogenic properties in periodontal intrabony defects and calvarial models, there is a notable gap in the literature regarding its application in large, post-enucleation cystic cavities of the jaws. Furthermore, previous studies frequently utilized radiopaque carriers (such as calcium phosphates) that obscure early radiographic assessment of de novo mineralization.
So the aim of this study is to evaluate the osteogenic effect of metformin gel on bone healing within cystic cavities after enucleation
- Conditions
- Jaw Cysts, Metformin, Inflammatory Cyst, Cyst Enucleation, Odontogenic Cysts
- Being tested
- For the Experimental Arm: 1% Metformin Gel, For the Comparator / Control Arm: Placebo Gel
- Keywords
- metformin gel, jaw cysts, odontogenic cysts
- Medical subject headings
- Jaw Cysts, Odontogenic Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
For the Experimental Arm: 1% Metformin GelDrug
- For 1% Metformin Gel (Experimental Arm):
Intervention Description: Pure metformin hydrochloride powder is dissolved into a biocompatible, in-situ gelling base at a concentration of 10 mg/ml to prepare a high-viscosity 1% metformin gel. Following surgical enucleation and thorough irrigation of the odontogenic cystic cavity, the gel is applied directly into the residual bony defect to act as a bioactive tissue-engineering matrix.
For the Comparator / Control Arm: Placebo GelDrug
For Placebo Gel (Comparator Arm):
Intervention Description: A visually and physically identical methylcellulose-based placebo gel. Following surgical enucleation and thorough irrigation of the odontogenic cystic cavity, the placebo gel is applied directly into the residual bony defect in an identical manner to maintain double-blinding
| Study group | Role | What they receive |
|---|---|---|
| Metformin Gel Group (Experimental) | Experimental | Patients in this group will undergo surgical enucleation of their radiolucent odontogenic jaw cysts, followed by packing the residual bony cavity with an active 1% metformin gel prepared as a bioactive tissue-engineering matrix Receives: Drug: For the Experimental Arm: 1% Metformin Gel |
| Placebo Gel Group | Placebo comparator | Patients in this group will undergo surgical enucleation of their radiolucent odontogenic jaw cysts, followed by packing the residual bony cavity with an identical placebo gel Receives: Drug: For the Comparator / Control Arm: Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Volume
Absolute bone volume (mm3) measured using Cone Beam Computed Tomography (CBCT) coupled with 3D volumetric segmentation software (e.g., Mimics).
Measured: After 6 months postoperatively
Secondary outcomes (1)
Relative Bone density
Measurement of relative bone density expressed as Gray Scale Value (GSV) using Cone Beam Computed Tomography (CBCT).
Measured: After 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Jaw CystsStudies of the same condition, open and under way.
- 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
- This is a prospective, randomized, controlled, double-blinded clinical trial designed to evaluate the osteogenic efficacy of a locally applied 1% metformin gel on bone regeneration within bony defects following the surgical enucleation of odontogenic jaw cysts. A total of 32 patients will be randomly allocated into two parallel groups (1:1 ratio) 16 patients in each arm,to either receive the active 1% metformin gel or an identical placebo methylcellulose gel packed into the post-enucleation cavity. The primary outcome measures bone volume using Cone Beam Computed Technology (CBCT) coupled with 3D volumetric segmentation software after 6 months
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed ElAmir Salah, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867236
- Sponsor's protocol ID
- osteogenic effect of metformin
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Plan Description \& Operational Flow 1. Study Overview \& Design\*\* This study is structured as a prospective, single-center, randomized, double-blind, parallel-group controlled clinical trial designed to evaluate the therapeutic and regenerative efficacy of a local intervention. The primary purpose of this trial is treatment, focusing on enhancing bone healing and regeneration within residual bony defects following the surgical enucleation of radiolucent odontogenic jaw cysts. 2. Allocation and Randomization Allocation Method: Randomized controlled trial with a 1:1 parallel assignment ratio. Randomization Procedure: Eligible participants are allocated using unstratified block randomization. Computer-generated random sequences are c
Publications
Fontana F, Maschera E, Rocchietta I, Simion M. Clinical classification of complications in guided bone regeneration procedures by means of a nonresorbable membrane. Int J Periodontics Restorative Dent. 2011 Jun;31(3):265-73.
PubMed 21556383Kang YJ, Kim MK, Kim SG, Park YW, Oh JH. Predicting Risk Factors for Complications in Jaw Cyst Treatment: Insights from a Retrospective Study. J Korean Assoc Oral Maxillofac Surg. 2025 Feb 28;51(1):33-40. doi: 10.5125/jkaoms.2025.51.1.33.
PubMed 40017072Shokry MMEM, Melek LNF, Amer TA. Three-dimensional volumetric analysis of bone regeneration following jaw cyst enucleation with and without an autologous albumin gel-platelet-rich fibrin mixture (Alb-PRF): a randomized controlled clinical trial. BMC Oral Health. 2025 May 8;25(1):693. doi: 10.1186/s12903-025-06027-w.
PubMed 40340767Chacko R, Kumar S, Paul A, Arvind. Spontaneous Bone Regeneration After Enucleation of Large Jaw Cysts: A Digital Radiographic Analysis of 44 Consecutive Cases. J Clin Diagn Res. 2015 Sep;9(9):ZC84-9. doi: 10.7860/JCDR/2015/13394.6524. Epub 2015 Sep 1.
PubMed 26501020Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available.
PubMed 18538699Lingamaneni S, Mandadi LR, Pathakota KR. Assessment of healing following low-level laser irradiation after gingivectomy operations using a novel soft tissue healing index: A randomized, double-blind, split-mouth clinical pilot study. J Indian Soc Periodontol. 2019 Jan-Feb;23(1):53-57. doi: 10.4103/jisp.jisp_226_18.
PubMed 30692744Kim HY, Lee SM, Park JH, Kim SJ. Three-dimensional analysis of decompression efficacy and influencing factors in the maxillofacial cystic lesions: a retrospective study. J Korean Assoc Oral Maxillofac Surg. 2024 Aug 31;50(4):197-205. doi: 10.5125/jkaoms.2024.50.4.197.
PubMed 39211968Sabbagh M, Khairallah CM, Saleh A, Chaanine C. Volumetric Radiological Analysis of Bone Regeneration After Jaw Cyst Enucleation Without Grafting Material: A Retrospective Pilot Study. Cureus. 2025 Oct 1;17(10):e93636. doi: 10.7759/cureus.93636. eCollection 2025 Oct.
PubMed 41181751Montalban-Vadillo O, Perez-Pevida E, Viteri-Agustin I, Chavarri-Prado D, Estrada-Martinez A, Dieguez-Pereira M, Sanchez-Lasheras F, Brizuela-Velasco A. Effect of Applying 1% Metformin on Guided Bone Regeneration Processes with Bovine-Derived Xenografts. J Clin Med. 2024 May 18;13(10):2973. doi: 10.3390/jcm13102973.
PubMed 38792514Pradeep AR, Patnaik K, Nagpal K, Karvekar S, Guruprasad CN, Kumaraswamy KM. Efficacy of 1% Metformin Gel in Patients With Moderate and Severe Chronic Periodontitis: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Oct;88(10):1023-1029. doi: 10.1902/jop.2017.150096. Epub 2017 Jul 21.
PubMed 28731373Wang P, Ma T, Guo D, Hu K, Shu Y, Xu HHK, Schneider A. Metformin induces osteoblastic differentiation of human induced pluripotent stem cell-derived mesenchymal stem cells. J Tissue Eng Regen Med. 2018 Feb;12(2):437-446. doi: 10.1002/term.2470. Epub 2017 Aug 11.
PubMed 28494141Vestergaard P, Rejnmark L, Mosekilde L. Relative fracture risk in patients with diabetes mellitus, and the impact of insulin and oral antidiabetic medication on relative fracture risk. Diabetologia. 2005 Jul;48(7):1292-9. doi: 10.1007/s00125-005-1786-3. Epub 2005 May 21.
PubMed 15909154Gao Y, Xue J, Li X, Jia Y, Hu J. Metformin regulates osteoblast and adipocyte differentiation of rat mesenchymal stem cells. J Pharm Pharmacol. 2008 Dec;60(12):1695-700. doi: 10.1211/jpp.60/12.0017.
PubMed 19000376LeGeros RZ. Properties of osteoconductive biomaterials: calcium phosphates. Clin Orthop Relat Res. 2002 Feb;(395):81-98. doi: 10.1097/00003086-200202000-00009.
PubMed 11937868Makki AZ, Alsulami AM, Almatrafi AS, Sindi MZ, Sembawa SN. The Effectiveness of Advanced Platelet-Rich Fibrin in comparison with Leukocyte-Platelet-Rich Fibrin on Outcome after Dentoalveolar Surgery. Int J Dent. 2021 May 8;2021:6686857. doi: 10.1155/2021/6686857. eCollection 2021.
PubMed 34046064
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Osteogenic Potential of Topical Metformin Gel on Bone Regeneration in Cystic Jaw Defects: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07867236
- Acronym / sponsor ID
- osteogenic effect of metformin
- Conditions
- Jaw Cysts, Metformin, Inflammatory Cyst, Cyst Enucleation, Odontogenic Cysts
- Keywords
- metformin gel, jaw cysts, odontogenic cysts
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 9 Oct 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.
Evaluate the osteogenic effect of locally applied 1% metformin gel on bone volume formation after jaw cystic defects enucleation
Detailed description
Odontogenic jaw cysts, represent a significant portion of the pathological lesions encountered in daily oral and maxillofacial surgery. They account for approximately 15% of all oral biopsies and predominantly affect patients in their second to fourth decades of life (1). Following the surgical enucleation of a cyst, a bony defect remains. Traditionally, the standard practice has been to allow this cavity to fill with a blood clot, relying on natural biological processes to eventually form new bone.(2) However, unassisted healing is often unpredictable. The natural healing timeline can be slow, sometimes resulting in the ingrowth of fibrous scar tissue rather than solid bone (3). More importantly, the alveolar ridge often collapses during these prolonged months of healing. This dimensional loss creates a significant rehabilitation problem, particularly if the patient requires a dental implant in the future.(4) Management of the residual dead space following jaw cyst enucleation has been highly debated, with treatment protocols evolving significantly over the past decades. Early approaches relied solely on the spontaneous organization of the blood clot; however, this often leads to soft tissue invagination and incomplete bony contouring in critical-sized defects greater than 3 cm (4,5). To provide structural support, autologous bone grafting became the historical gold standard, though its routine use is now heavily deterred by severe donor-site morbidity and increased surgical time (5). Subsequent shifts toward xenografts and human allografts reduced donor-site risks but presented new challenges, as these materials frequently exhibit unpredictable, prolonged resorption times that impede natural host bone remodeling (6). In recent years, the focus has shifted toward autologous platelet concentrates (such as PRF) and synthetic bioceramics (such as Beta-Tricalcium Phosphate). While PRF is highly osteoinductive; it lacks the mechanical rigidity necessary to prevent tissue collapse in large cystic defects (7). Conversely, bioceramics provide excellent space maintenance, but their inherent high radiopacity, severely confounds early radiographic assessment, making it difficult to distinguish residual graft particles from true new bone formation and mineralization (8). Because current modalities urge for a compromise between mechanical support, predictable resorption, and radiographic clarity; there remains a critical need for a fully radiolucent, bioactive scaffold capable of accelerating bone regeneration.(7) Metformin (1,1-dimethylbiguanide hydrochloride) is an FDA-approved, first-line oral hypoglycemic agent utilized globally for the management of Type II Diabetes Mellitus. However, extensive in vitro and in vivo studies have revealed that Metformin possesses profound, glucose-independent pleiotropic effects on bone metabolism (9). Systemic administration of Metformin has been retrospectively associated with a decreased risk of bone fractures and enhanced bone mineral density in diabetic patients (10).
At the cellular level, Metformin functions as a potent osteoinductive agent primarily through the activation of the AMP-activated protein kinase (AMPK) pathway. Activation of AMPK by Metformin subsequently upregulates the expression of Runt-related transcription factor 2 (Runx2) and Osterix which are the master transcription factors required for the differentiation of mesenchymal stem cells into mature, matrix-producing osteoblasts (9-11). Furthermore, Metformin exerts a dual action by simultaneously inhibiting osteoclastogenesis. It suppresses the Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) expression, thereby reducing bone resorption and shifting the physiological balance toward net bone apposition (11).
In a series of randomized controlled clinical trials focused on periodontal regeneration, Pradeep et al. established that the intra-bony application of 1% Metformin gel resulted in significantly greater probing depth reduction and defect fill compared to placebo gels, confirming its clinical safety and regenerative potential in the alveolar bone (12). Montalbán et al used 1% metformin solution in an animal model of guided bone regeneration with particulate bovine hydroxyapatite and hyaluronate and the results revealed that higher average bone-biomaterial contact percentage was observed in the samples, with metformin in both the proximal and distal regions. (13) By formulating Metformin into a high-viscosity gel and injecting it directly into the surgical defect, the medication blends with the pooling blood. This approach transforms the patient's natural blood clot into an active tissue-engineering matrix. It accelerates bone regeneration and increases bone density, effectively bypassing the need for traditional physical bone grafts(14).
Despite the robust evidence supporting Metformin's osteogenic properties in periodontal intrabony defects and calvarial models, there is a notable gap in the literature regarding its application in large, post-enucleation cystic cavities of the jaws. Furthermore, previous studies frequently utilized radiopaque carriers (such as calcium phosphates) that obscure early radiographic assessment of de novo mineralization.
So the aim of this study is to evaluate the osteogenic effect of metformin gel on bone healing within cystic cavities after enucleation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, controlled, double-blinded clinical trial designed to evaluate the osteogenic efficacy of a locally applied 1% metformin gel on bone regeneration within bony defects following the surgical enucleation of odontogenic jaw cysts. A total of 32 patients will be randomly allocated into two parallel groups (1:1 ratio) 16 patients in each arm,to either receive the active 1% metformin gel or an identical placebo methylcellulose gel packed into the post-enucleation cavity. The primary outcome measures bone volume using Cone Beam Computed Technology (CBCT) coupled with 3D volumetric segmentation software after 6 months
| Arm | Type | Receives |
|---|---|---|
| Metformin Gel Group (Experimental) | Experimental | Drug: For the Experimental Arm: 1% Metformin GelPatients in this group will undergo surgical enucleation of their radiolucent odontogenic jaw cysts, followed by packing the residual bony cavity with an active 1% metformin gel prepared as a bioactive tissue-engineering matrix |
| Placebo Gel Group | Placebo comparator | Drug: For the Comparator / Control Arm: Placebo GelPatients in this group will undergo surgical enucleation of their radiolucent odontogenic jaw cysts, followed by packing the residual bony cavity with an identical placebo gel |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- o Healthy adults patients .
Key exclusion criteria (3 listed)
- o Medically compromised patients
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 |
|---|---|---|
| For the Experimental Arm: 1% Metformin Gel1. For 1% Metformin Gel (Experimental Arm): Intervention Description: Pure metformin hydrochloride powder is dissolved into a biocompatible, in-situ gelling base at a concentration of 10 mg/ml to prepare a high-viscosity 1% metformin gel. Following surgical enucleation and thorough irrigation of the odontogenic cystic cavity, the gel is applied directly into the residual bony defect to act as a bioactive tissue-engineering matrix. | Drug | Metformin Gel Group (Experimental) |
| For the Comparator / Control Arm: Placebo GelFor Placebo Gel (Comparator Arm): Intervention Description: A visually and physically identical methylcellulose-based placebo gel. Following surgical enucleation and thorough irrigation of the odontogenic cystic cavity, the placebo gel is applied directly into the residual bony defect in an identical manner to maintain double-blinding | Drug | Placebo Gel Group |
Primary outcome
Absolute Volume
Time frame: After 6 months postoperatively
Absolute bone volume (mm3) measured using Cone Beam Computed Tomography (CBCT) coupled with 3D volumetric segmentation software (e.g., Mimics).
1 secondary outcome
Relative Bone density
Time frame: After 6 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 14 Oct 2026.
- Background: PubMed 21556383Fontana F, Maschera E, Rocchietta I, Simion M. Clinical classification of complications in guided bone regeneration procedures by means of a nonresorbable membrane. Int J Periodontics Restorative Dent. 2011 Jun;31(3):265-73.
- Background: PubMed 40017072Kang YJ, Kim MK, Kim SG, Park YW, Oh JH. Predicting Risk Factors for Complications in Jaw Cyst Treatment: Insights from a Retrospective Study. J Korean Assoc Oral Maxillofac Surg. 2025 Feb 28;51(1):33-40. doi: 10.5125/jkaoms.2025.51.1.33.
- Background: PubMed 40340767Shokry MMEM, Melek LNF, Amer TA. Three-dimensional volumetric analysis of bone regeneration following jaw cyst enucleation with and without an autologous albumin gel-platelet-rich fibrin mixture (Alb-PRF): a randomized controlled clinical trial. BMC Oral Health. 2025 May 8;25(1):693. doi: 10.1186/s12903-025-06027-w.
- Background: PubMed 26501020Chacko R, Kumar S, Paul A, Arvind. Spontaneous Bone Regeneration After Enucleation of Large Jaw Cysts: A Digital Radiographic Analysis of 44 Consecutive Cases. J Clin Diagn Res. 2015 Sep;9(9):ZC84-9. doi: 10.7860/JCDR/2015/13394.6524. Epub 2015 Sep 1.
- Background: PubMed 18538699Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available.
- Background: PubMed 30692744Lingamaneni S, Mandadi LR, Pathakota KR. Assessment of healing following low-level laser irradiation after gingivectomy operations using a novel soft tissue healing index: A randomized, double-blind, split-mouth clinical pilot study. J Indian Soc Periodontol. 2019 Jan-Feb;23(1):53-57. doi: 10.4103/jisp.jisp_226_18.
- Background: PubMed 39211968Kim HY, Lee SM, Park JH, Kim SJ. Three-dimensional analysis of decompression efficacy and influencing factors in the maxillofacial cystic lesions: a retrospective study. J Korean Assoc Oral Maxillofac Surg. 2024 Aug 31;50(4):197-205. doi: 10.5125/jkaoms.2024.50.4.197.
- Background: PubMed 41181751Sabbagh M, Khairallah CM, Saleh A, Chaanine C. Volumetric Radiological Analysis of Bone Regeneration After Jaw Cyst Enucleation Without Grafting Material: A Retrospective Pilot Study. Cureus. 2025 Oct 1;17(10):e93636. doi: 10.7759/cureus.93636. eCollection 2025 Oct.
- Background: PubMed 38792514Montalban-Vadillo O, Perez-Pevida E, Viteri-Agustin I, Chavarri-Prado D, Estrada-Martinez A, Dieguez-Pereira M, Sanchez-Lasheras F, Brizuela-Velasco A. Effect of Applying 1% Metformin on Guided Bone Regeneration Processes with Bovine-Derived Xenografts. J Clin Med. 2024 May 18;13(10):2973. doi: 10.3390/jcm13102973.
- Background: PubMed 28731373Pradeep AR, Patnaik K, Nagpal K, Karvekar S, Guruprasad CN, Kumaraswamy KM. Efficacy of 1% Metformin Gel in Patients With Moderate and Severe Chronic Periodontitis: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Oct;88(10):1023-1029. doi: 10.1902/jop.2017.150096. Epub 2017 Jul 21.
- Background: PubMed 28494141Wang P, Ma T, Guo D, Hu K, Shu Y, Xu HHK, Schneider A. Metformin induces osteoblastic differentiation of human induced pluripotent stem cell-derived mesenchymal stem cells. J Tissue Eng Regen Med. 2018 Feb;12(2):437-446. doi: 10.1002/term.2470. Epub 2017 Aug 11.
- Background: PubMed 15909154Vestergaard P, Rejnmark L, Mosekilde L. Relative fracture risk in patients with diabetes mellitus, and the impact of insulin and oral antidiabetic medication on relative fracture risk. Diabetologia. 2005 Jul;48(7):1292-9. doi: 10.1007/s00125-005-1786-3. Epub 2005 May 21.
- Individual participant dataSharing planned: Yes. Study Plan Description \& Operational Flow 1. Study Overview \& Design** This study is structured as a prospective, single-center, randomized, double-blind, parallel-group controlled clinical trial designed to evaluate the therapeutic and regenerative efficacy of a local intervention. The primary purpose of this trial is treatment, focusing on enhancing bone healing and regeneration within residual bony defects following the surgical enucleation of radiolucent odontogenic jaw cysts. 2. Allocation and Randomization Allocation Method: Randomized controlled trial with a 1:1 parallel assignment ratio. Randomization Procedure: Eligible participants are allocated using unstratified block randomization. Computer-generated random sequences are c
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing For the Experimental Arm: 1% Metformin Gel in people with Jaw Cysts and Metformin, run by Fayoum 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 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: opening soon, as of the sponsor's last update on 14 Oct 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. Some participants in this study may receive a placebo. 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?
Contact Ahmed ElAmir Salah, Bachelor degree of dentistry (00201220865794, ahmed.elamer@dent.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Volume (time frame: After 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07867236, which also lists 19 linked publications.
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 14 Oct 2026.