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NCT Number: NCT07330726

Lidocaine Patch and Lower Third Molar

* 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine patch

Drug

transmucosal lidocaine patch after third molar tooth removal

Placebo Patch

Drug

transmucosal placebo patch after third molar tooth removal

Primary outcomes

  1. Pain intensity

    Time frame: 7 days postoperative

    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).

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

The Efficacy of a Transmucosal Lidocaine Patch on Postoperative Pain Following Mandibular Third Molar Extraction

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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