Impacted Third Molar ToothPhase 3NCT07330726
Lidocaine Patch and Lower Third Molar
A Phase 3 study testing Lidocaine patch in people with Impacted Third Molar Tooth, run by Fayoum University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Lidocaine patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 30 Apr 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age ≥18ys
- no systemic disease
- impacted mandibular third molar class II position B on Pell- Gregory classification
Who cannot join
- • 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.
About this study
Official title: The Efficacy of a Transmucosal Lidocaine Patch on Postoperative Pain Following Mandibular Third Molar Extraction
- 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
- Being tested
- Lidocaine patch, placebo patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine patchDrug
transmucosal lidocaine patch after third molar tooth removal
placebo patchDrug
transmucosal placebo patch after third molar tooth removal
| Study group | Role | What they receive |
|---|---|---|
| lidocaine patch | Experimental | Not described Receives: Drug: Lidocaine patch |
| placeboo patch | Placebo comparator | Not described Receives: Drug: placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohsen, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330726
- Sponsor's protocol ID
- 37
- Status last verified
- Dec 2025
- First submitted
- 28 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Transmucosal Lidocaine Patch on Postoperative Pain Following Mandibular Third Molar Extraction
- ClinicalTrials.gov ID
- NCT07330726
- Acronym / sponsor ID
- 37
- Conditions
- Impacted Third Molar Tooth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine patch | Experimental | Drug: Lidocaine patch |
| placeboo patch | Placebo comparator | Drug: placebo patch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Age ≥18ys
Key exclusion criteria (6 listed)
- • history of metabolic or systemic diseases affecting bone or healing process,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine patchtransmucosal lidocaine patch after third molar tooth removal | Drug | lidocaine patch |
| placebo patchtransmucosal placebo patch after third molar tooth removal | Drug | placeboo patch |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine patch in people with Impacted Third Molar Tooth, run by Fayoum University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 7 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.