Assessment of Osteogenic Potential of Topical Metformin Gel on Bone Regeneration in Cystic Jaw Defects: Randomized Controlled Clinical Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorFayoum University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • For the Experimental Arm: 1% Metformin Gel

    Drug

    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 the Comparator / Control Arm: Placebo Gel

    Drug

    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

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Metformin Gel Group (Experimental)Experimental treatment 1 intervention
Group B: Placebo Gel GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

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