Lidocaine Patch and Lower Third Molar

NCT07330726 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 37
• Study Type: interventional
• Target: 21
• 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.
• 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.
• Control side : use transmucosal placebo patch
• Study side: use transmucosal lidocaine patch Postoperative care
• Postoperatively, the patients were instructed to apply ice bags 20 min/hour for the next 6 hours to the surgical side, eat soft cold diet by the aid of a straw and to avoid hot diet and fluid on the day of surgery.
• Sutures were removed after 7 days postoperatively.
• All the patients will be evaluated on the 1st, 3rd, and 7th postoperative days for pain, preoperative and postoperative mouth opening, and degree of postoperative swelling.

Conditions

Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Pain was assessed using a visual analogue scale (VAS) of 10 units in combination with a graphic rating scale. On the VAS, the left most end represented the absence of pain (score 0) and the right most end indicated the most severe pain (score 10).

  7 days postoperative

Study Arms (2)

lidocaine patch

EXPERIMENTAL

Drug: Lidocaine patch

placeboo patch

PLACEBO COMPARATOR

Drug: placebo patch

Interventions

Lidocaine patch DRUG

transmucosal lidocaine patch after third molar tooth removal

lidocaine patch

placebo patch DRUG

transmucosal placebo patch after third molar tooth removal

placeboo patch

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 9, 2026
• Study Start: January 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 30, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12