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

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07414797

Acronym

OLP_BIOP

Enrollment

112

Registered

2026-02-17

Start date

2023-01-11

Completion date

2025-03-06

Last updated

2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biopsy, Oral Lichen Planus

Keywords

biopsy, oral lichen planus, patient reported outcomes

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).

Interventions

PROCEDURELaser 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.

PROCEDUREPunch 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical healing assessed by the modified Landry Healing Index	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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026