NCT07414797

Discomfort Following Oral Biopsy Comparing Laser and Punch Biopsy

Clinical Healing and Patient Discomfort Following Oral Biopsy in Oral Lichen Planus: a Randomized Controlled Non-inferiority Trial Comparing Laser and Punch Biopsy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-01-11
• Primary completion: 2025-01-23
• Completion: 2025-03-06
• First posted: 2026-02-17
• Last updated: 2026-02-18

Locations

1 site across 1 country: Italy