Clinical Healing and Patient Discomfort Following Oral Biopsy in Oral Lichen Planus: a Randomized Controlled Non-inferiority Trial Comparing Laser and Punch Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Clinical healing assessed by the modified Landry Healing Index
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Punch Biopsy (Procedure)
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.
干预措施: Laser Biopsy (Procedure)
结局指标
主要结局
Clinical healing assessed by the modified Landry Healing Index
时间窗: 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.
Clinical healing assessed by the modified Landry Healing Index
时间窗: 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.
次要结局
未报告次要终点
研究者
Carlo Lajolo
Assistant Professor
Catholic University of the Sacred Heart