Discomfort Following Oral Biopsy Comparing Laser and Punch Biopsy (NCT07414797) | Clinical Trial Compass
CompletedNot Applicable
Discomfort Following Oral Biopsy Comparing Laser and Punch Biopsy
Italy112 participantsStarted 2023-01-11
Plain-language summary
Oral biopsy is essential for diagnosing mucosal lesions such as oral lichen planus (OLP). Laser surgery offers a minimally invasive alternative to traditional techniques, but thermal effects may impact healing and postoperative comfort. The aim of this study was to compare the degree of clinical healing and postoperative discomfort between laser and punch scalpel biopsy techniques in patients with OLP.
This was a single-center, parallel-group, noninferiority, randomized, blinded, controlled trial. One hundred and twelve adults with clinically and histologically confirmed OLP were randomized and allocated into two groups. Test group (diode laser) and control group (punch scalpel).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical healing assessed by the modified Landry Healing Index
Timeframe: 7 days after the procedure
2
Clinical healing assessed by the modified Landry Healing Index