Discomfort Following Oral Biopsy Comparing Laser and Punch Biopsy

NCT07414797 | Completed

• 1 other identifier: ID-4362
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Oral Lichen Planus; Biopsy

Keywords

biopsy; oral lichen planus; patient reported outcomes

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

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.

Procedure: Punch Biopsy

Interventions

Laser Biopsy PROCEDURE

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.

Diode Laser Biopsy

Punch Biopsy PROCEDURE

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.

Punch Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli

Roma, RM, 00168, Italy

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 17, 2026
• Study Start: January 11, 2023
• Primary Completion: January 23, 2025
• Study Completion: March 6, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)