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Laser vs scalpel: which biopsy hurts less for mouth disease?

NCT ID NCT07414797

Knowledge-focused Sponsor: Catholic University of the Sacred Heart Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether using a laser for oral biopsies causes less pain and heals better than the standard punch scalpel in people with oral lichen planus. 112 adults were randomly assigned to one of the two methods. Researchers measured wound healing and discomfort after the procedure to see if the laser is a good alternative.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If laser biopsy proves better or equal, it could become the preferred method for diagnosing oral lichen planus, reducing patient discomfort.
What could go wrong
This is a small, single-center study comparing two procedures, not a treatment. Results may not apply to all patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

112 people

The number who actually took part.

Started

Jan 2023

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * clinical and histological OLP diagnosis according to the WHO diagnostic criteria modified by van der Meij and van der Waal (4), age ≥18 years * indication for oral incisional biopsy involving the dorsal tongue and buccal mucosa. Exclusion Criteria: * oral lichenoid lesions (OLLs) according to the recent WHO classification of OPMD; * anamnesis of hematopoietic stem cell transplant; * OSCC concomitant with OLP diagnosis, * inability to attend follow-up visits, * psychiatric disorders, * insufficient Italian language comprehension, * local corticosteroid therapy within the previous three months. * chronic pharmacological treatment with drugs known to influence nociceptive sensitivity

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Conditions

The condition(s) this trial relates to.

lichen planus, oral

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BIOPSY Oral lichen planus

Contacts and locations

Locations

  • Fondazione Policlinico Universitario A. Gemelli

    Roma, RM, 00168, Italy

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