Discomfort Following Oral Biopsy Comparing Laser and Punch Biopsy (OLP_BIOP)

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).

Study Overview

• Status: Completed
• Conditions: Oral Lichen Planus; Biopsy
• Intervention / Treatment: Procedure: Laser Biopsy; Procedure: Punch Biopsy

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00168
      • Fondazione Policlinico Universitario A. Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diode Laser Biopsy; 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.	Procedure: Laser Biopsy; 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.
Active Comparator: Punch Biopsy; 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.	Procedure: Punch Biopsy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	21 days after the procedure

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Actual): January 23, 2025
• Study Completion (Actual): March 6, 2025

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: oral lichen planus; patient reported outcomes; biopsy
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Lichen Planus; Lichen Planus, Oral
• Other Study ID Numbers: ID-4362

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No