About this trial
Evaluate the osteogenic effect of locally applied 1% metformin gel on bone volume formation after jaw cystic defects enucleation
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Parallel
Treatments tested in this trial
For the Experimental Arm: 1% Metformin Gel
Drug1\. 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 Gel
DrugFor 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
Treatment groups
Trial outcomes
Primary outcomes
Absolute Volume
Absolute bone volume (mm3) measured using Cone Beam Computed Tomography (CBCT) coupled with 3D volumetric segmentation software (e.g., Mimics).
Secondary outcomes
Relative Bone density
Measurement of relative bone density expressed as Gray Scale Value (GSV) using Cone Beam Computed Tomography (CBCT).
Sponsors and contacts
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