Local Metformin Gel and Impacted Lower Third Molar

NCT06975839 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 8
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (1)

• bone dentisty

  by CBCT

  6months

Study Arms (2)

metformin

EXPERIMENTAL

Drug: Metformin

non metformin

ACTIVE COMPARATOR

Drug: non metformin gel

Interventions

Metformin DRUG

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

metformin

non metformin gel DRUG

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

non metformin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fayoum University: lead

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 16, 2025
• Study Start: June 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05