[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659739":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":31,"studyPopulation":17,"armGroups":32,"interventions":45,"overallOfficials":17,"centralContacts":55,"locations":61,"responsibleParty":73,"collaborators":17,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":17,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":17,"maxAge":17,"enrollmentInfo":85,"targetDuration":17,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":98,"overallStatus":102,"whyStopped":17,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Fayoum University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Absolute Volume","Absolute bone volume (mm3) measured using Cone Beam Computed Tomography (CBCT) coupled with 3D volumetric segmentation software (e.g., Mimics).","After 6 months postoperatively",[14],{"measure":15,"description":16,"timeFrame":12},"Relative Bone density","Measurement of relative bone density expressed as Gray Scale Value (GSV) using Cone Beam Computed Tomography (CBCT).",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","PARALLEL","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","TREATMENT",{"masking":24,"maskingDescription":25,"whoMasked":26},"QUADRUPLE","This is a double-blind, randomized controlled trial utilizing a 1:1 parallel allocation ratio. To maintain blinding, the active 1% metformin gel and the placebo methylcellulose gel are prepared as visually and physically identical pharmacological preparations. The following key study participants and personnel are strictly blinded to the group allocations throughout the trial:Participants: Blinded to whether they receive the active metformin gel or the placebo gel. Care Providers \u002F Surgeons: The primary operating surgeons are blinded during the surgical procedures. Investigators: Blinded to group assignments. Outcomes Assessors: All baseline, volumetric, and radiographic follow-up outcome data are assessed independently by the co-supervisor, who remains blinded to the patient allocation.",[27,28,29,30],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","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).\n\nAt 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).\n\nIn 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).\n\nDespite 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.\n\nSo the aim of this study is to evaluate the osteogenic effect of metformin gel on bone healing within cystic cavities after enucleation",[33,39],{"label":34,"type":35,"description":36,"interventionNames":37},"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",[38],"Drug: For the Experimental Arm: 1% Metformin Gel",{"label":40,"type":41,"description":42,"interventionNames":43},"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",[44],"Drug: For the Comparator \u002F Control Arm: Placebo Gel",[46,51],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":17},"DRUG","For the Experimental Arm: 1% Metformin Gel","1\\. For 1% Metformin Gel (Experimental Arm):\n\nIntervention Description: Pure metformin hydrochloride powder is dissolved into a biocompatible, in-situ gelling base at a concentration of 10 mg\u002Fml 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.",[34],{"type":47,"name":52,"description":53,"armGroupLabels":54,"otherNames":17},"For the Comparator \u002F Control Arm: Placebo Gel","For Placebo Gel (Comparator Arm):\n\nIntervention 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",[40],[56],{"name":57,"role":58,"phone":59,"phoneExt":17,"email":60},"Ahmed ElAmir Salah, Bachelor degree of dentistry","CONTACT","00201220865794","ahmed.elamer@dent.bsu.edu.eg",[62],{"facility":5,"status":17,"city":63,"state":64,"zip":17,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":17},"Al Fayyum","Faiyum Governorate","Egypt","EG",{"type":68,"coordinates":69},"Point",[70,71],30.8418,29.30995,{"lat":71,"lon":70},{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Ahmed ElAmir Salah","Mr","100659739","assessment-of-osteogenic-potential-of-topical-metformin-gel-on-bone-regeneration-in-cystic-jaw-defects-randomized-controlled-clinical-trial-100659739",false,"NCT07867236","Assessment of Osteogenic Potential of Topical Metformin Gel on Bone Regeneration in Cystic Jaw Defects: Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* o Healthy adults patients .\n\n  * Confirmed radiolucent odontogenic cysts requiring enucleation.\n  * The cystic defect range 5cmto ≤15cm (19)\n  * Good oral hygiene and strict commitment to attend follow-up scans.\n\nExclusion Criteria:\n\n* o Medically compromised patients\n\n  * Heavy smokers (consuming more than 10 cigarettes a day).\n  * Active, acute purulent infection at the surgical site (this must be resolved before surgery).",true,"ALL",{"count":86,"type":87},32,"ESTIMATED","INTERVENTIONAL",[90],"NA","Evaluate the osteogenic effect of locally applied 1% metformin gel on bone volume formation after jaw cystic defects enucleation",[93,94,95,96,97],"Jaw Cysts","Metformin","Inflammatory Cyst","Cyst Enucleation","Odontogenic Cysts",[99,100,101],"metformin gel","jaw cysts","odontogenic cysts","NOT_YET_RECRUITING","2026-10-05",{"date":105,"type":106},"2026-10-09","ACTUAL",{"date":108,"type":87},"2026-10-30",{"date":110,"type":87},"2027-10-30",{"name":5,"class":6},1]