An interventional study of For the Experimental Arm: 1% Metformin Gel and For the Comparator / Control Arm: Placebo Gel in Jaw Cysts, Metformin and Inflammatory Cyst, sponsored by Fayoum University. Not yet recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Fayoum University · Not applicable, Interventional, and Treatment
Evaluate the osteogenic effect of locally applied 1% metformin gel on bone volume formation after jaw cystic defects enucleation
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
Fayoum University is the lead sponsor of 146 studies on the registry; 43 are open to participants now.
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o Healthy adults patients .
Exclusion Criteria:
o Medically compromised patients
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
Drug: For the Experimental Arm: 1% Metformin Gel
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
Drug: For the Comparator / Control Arm: Placebo Gel
1\. 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 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
Absolute Volume
Absolute bone volume (mm3) measured using Cone Beam Computed Tomography (CBCT) coupled with 3D volumetric segmentation software (e.g., Mimics).
Time frame: After 6 months postoperatively
Relative Bone density
Measurement of relative bone density expressed as Gray Scale Value (GSV) using Cone Beam Computed Tomography (CBCT).
Time frame: After 6 months postoperatively
Plan to share: Yes — Study Plan Description \& Operational Flow 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. 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
Supporting information: Study protocol
Time frame: Primary Outcome Time Frame: 6 months postoperatively Secondary Outcome Time Frame: 6 months postoperatively
Access criteria: Qualified researchers, independent investigators, and academic institutions seeking to conduct secondary analyses or meta-analyses related to the study's objectives.
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Studies of the drug tested here: Metformin
Jaw Cysts