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

NCT07867236 | Not Yet Recruiting

• 1 other identifier: osteogenic effect of metformin
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the osteogenic effect of locally applied 1% metformin gel on bone volume formation after jaw cystic defects enucleation

Conditions

Jaw Cysts; Metformin; Inflammatory Cyst; Cyst Enucleation; Odontogenic Cysts

Keywords

metformin gel; jaw cysts; odontogenic cysts

Outcome Measures

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).

  After 6 months postoperatively

Secondary Outcomes (1)

• Relative Bone density

  After 6 months postoperatively

Study Arms (2)

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

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

Drug: For the Comparator / Control Arm: Placebo Gel

Interventions

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.

Metformin Gel Group (Experimental)

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

Placebo Gel Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum University

Al Fayyum, Faiyum Governorate, Egypt

Location

Related Publications (19)

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  PMID: 39548448 RESULT

MeSH Terms

Conditions

Jaw Cysts; Odontogenic Cysts

Condition Hierarchy (Ancestors)

Bone Cysts; Cysts; Neoplasms; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases

Central Study Contacts

Ahmed ElAmir Salah, Bachelor degree of dentistry

CONTACT

00201220865794; ahmed.elamer@dent.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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 / 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Model Details: 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

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

EG (1)