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OpenTrials
Completed

NCT Number: NCT07414797

Discomfort Following Oral Biopsy 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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A. Gemelli

Roma, RM, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study title

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

Acronym: OLP_BIOP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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