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Local Metformin Gel and Impacted Lower Third Molar

Evaluate the Efficacy of Local Metformin Gel Application Following Surgical Removal of Mandibular Third Molar

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06975839
Enrollment
36
Registered
2025-05-16
Start date
2025-06-01
Completion date
2026-02-01
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impacted Third Molar Tooth

Brief summary

* Completed medical and dental history will take for all patients and the position of the impacted teeth will evaluate by panoramic films. Patients will fully inform about the treatment procedures, follow-up examinations and complications of surgical procedures. * The study will be carried out as a randomized controlled clinical trial. Randomly, by the use of predefined computer-generated randomization table, the eligible patients will be randomized in equal proportions between Study group: patients will receive 1% Metformin gel in the socket following removal of the impacted third molar and Control group: patients will receive placebo gel 2% hydroxymethyl cellulose.All surgeries will be performed under complete aseptic conditions. Before surgery, the patient's mouth will be rinsed with a chlorhexidine digluconate solution 0.2% for 2 minutes. Surgery will carry out under local anesthesia consisting of 4% articain hydrochloride with 1:100,000 adrenaline. * Full thickness mucoperiosteal flap will be raised to expose sufficient bone on lateral and distal aspect of the impacted molar. Removal of bone will be done with stainless steel bur under Constant irrigation with normal saline while removing bone to prevent thermal necrosis. * When necessary, sectioning of crown and roots will be performed with a fissure bur. After tooth extraction, the alveolus will be inspected, curetted, and irrigated with 0.9% sterile saline solution. * Surgical removal of impacted mandibular third molar will be done,1% metformin gel or placebo gel in the socket following removal of the impacted third molar . * The mucoperiosteal flap will be repositioned and sutured with 3-0 black silk suture.

Interventions

DRUGMetformin

local application of metformin gel after surgical removal of lower third molar tooth

DRUGnon metformin gel

local application of placebo gel after surgical removal of lower third molar tooth

Sponsors

Fayoum University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* • Age ≥18ys * no systemic disease * impacted mandibular third molar class II position B on Pell- Gregory classification

Exclusion criteria

* • history of metabolic or systemic diseases affecting bone or healing process, * local infection, * tobacco use, * oral contraceptive, * pregnancy and lactation * patients who had taken analgesics or anti-inflammatories for 1 week prior to enrollment in the study

Design outcomes

Primary

MeasureTime frameDescription
bone dentisty6monthsby CBCT

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026