Oral Lichen PlanusOLP_BIOPNCT07414797
Discomfort Following Oral Biopsy Comparing Laser and Punch Biopsy
A study testing Laser Biopsy and Punch Biopsy in people with Oral Lichen Planus and Biopsy, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Lichen Planus, Biopsy
- What is being tested?
- Laser Biopsy and Punch Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jan 2023to 6 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Healing and Patient Discomfort Following Oral Biopsy in Oral Lichen Planus: a Randomized Controlled Non-inferiority Trial Comparing Laser and Punch Biopsy
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).
- Conditions
- Oral Lichen Planus, Biopsy
- Being tested
- Laser Biopsy, Punch Biopsy
- Keywords
- biopsy, oral lichen planus, patient reported outcomes
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser BiopsyProcedure or surgery
Biopsies were performed via a diode laser (980 nm wavelength) after local perilesional anaesthesia with 2% mepivacaine with a vasoconstrictor (1:100,000). A 6 mm tissue sample was excised, and the wound was generally allowed to heal by secondary intention; sutures were placed only in selected cases at the discretion of the operator. A specific surgical stent with a diameter of 6 mm was used to ensure identical sample dimensions for both groups.
Punch BiopsyProcedure or surgery
Biopsies were performed via a 6 mm punch scalpel after local perilesional anaesthesia with 2% mepivacaine with a vasoconstrictor (1:100,000). Hemostasis and suturing were carried out as needed.
| Study group | Role | What they receive |
|---|---|---|
| Diode Laser Biopsy | Experimental | Laser Biopsy (Test Group): Biopsies were performed via a diode laser (980 nm wavelength) after local perilesional anaesthesia with 2% mepivacaine with a vasoconstrictor (1:100,000). A 6 mm tissue sample was excised, and the wound was generally allowed to heal by secondary intention; sutures were placed only in selected cases at the discretion of the operator. A specific surgical stent with a diameter of 6 mm was used to ensure identical sample dimensions for both groups. Receives: Procedure: Laser Biopsy |
| Punch Biopsy | Active comparator | Punch scalpel biopsy (control group): Biopsies were performed via a 6 mm punch scalpel after local perilesional anaesthesia with 2% mepivacaine with a vasoconstrictor (1:100,000). Hemostasis and suturing were carried out as needed. Receives: Procedure: Punch Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical healing assessed by the modified Landry Healing Index
Wound healing was assessed via the modified healing index after surgery by a blinded operator. This healing index ranges between 0 and 9, with 0 indicating the worst possible healing and 9 indicating the best one.
Measured: 7 days after the procedure
Clinical healing assessed by the modified Landry Healing Index
Wound healing was assessed via the modified healing index after surgery by a blinded operator. This healing index ranges between 0 and 9, with 0 indicating the worst possible healing and 9 indicating the best one.
Measured: 21 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start11 Jan 2023
- Primary completion23 Jan 2025
- Study completion6 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Lajolo, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414797
- Sponsor's protocol ID
- ID-4362
- Acronym
- OLP_BIOP
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Healing and Patient Discomfort Following Oral Biopsy in Oral Lichen Planus: a Randomized Controlled Non-inferiority Trial Comparing Laser and Punch Biopsy
- ClinicalTrials.gov ID
- NCT07414797
- Acronym / sponsor ID
- OLP_BIOP / ID-4362
- Conditions
- Oral Lichen Planus, Biopsy
- Keywords
- biopsy, oral lichen planus, patient reported outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 17 Feb 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diode Laser Biopsy | Experimental | Procedure: Laser BiopsyLaser Biopsy (Test Group): Biopsies were performed via a diode laser (980 nm wavelength) after local perilesional anaesthesia with 2% mepivacaine with a vasoconstrictor (1:100,000). A 6 mm tissue sample was excised, and the wound was generally allowed to heal by secondary intention; sutures were placed only in selected cases at the discretion of the operator. A specific surgical stent with a diameter of 6 mm was used to ensure identical sample dimensions for both groups. |
| Punch Biopsy | Active comparator | Procedure: Punch BiopsyPunch scalpel biopsy (control group): Biopsies were performed via a 6 mm punch scalpel after local perilesional anaesthesia with 2% mepivacaine with a vasoconstrictor (1:100,000). Hemostasis and suturing were carried out as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
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 |
|---|---|---|
| Laser BiopsyBiopsies were performed via a diode laser (980 nm wavelength) after local perilesional anaesthesia with 2% mepivacaine with a vasoconstrictor (1:100,000). A 6 mm tissue sample was excised, and the wound was generally allowed to heal by secondary intention; sutures were placed only in selected cases at the discretion of the operator. A specific surgical stent with a diameter of 6 mm was used to ensure identical sample dimensions for both groups. | Procedure or surgery | Diode Laser Biopsy |
| Punch BiopsyBiopsies were performed via a 6 mm punch scalpel after local perilesional anaesthesia with 2% mepivacaine with a vasoconstrictor (1:100,000). Hemostasis and suturing were carried out as needed. | Procedure or surgery | Punch Biopsy |
Primary outcome
Clinical healing assessed by the modified Landry Healing Index
Time frame: 7 days after the procedure
Wound healing was assessed via the modified healing index after surgery by a blinded operator. This healing index ranges between 0 and 9, with 0 indicating the worst possible healing and 9 indicating the best one.
Clinical healing assessed by the modified Landry Healing Index
Time frame: 21 days after the procedure
Wound healing was assessed via the modified healing index after surgery by a blinded operator. This healing index ranges between 0 and 9, with 0 indicating the worst possible healing and 9 indicating the best one.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Biopsy and Punch Biopsy in people with Oral Lichen Planus and Biopsy, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical healing assessed by the modified Landry Healing Index (time frame: 7 days after the procedure). The study lists 2 primary outcomes in all. 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 18 Feb 2026.