Biomodulatory Effects of GaAlAs 940 nm on Pain Control and Wound Healing at Palatal Donor Site Following Free Gingival Graft Harvesting: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the biomodulatory effects of a 940-nm GaAlAs diode laser on postoperative pain control and wound healing at the palatal donor site following free gingival graft harvesting. Adult patients undergoing free gingival graft surgery will be randomly allocated to receive either a single session of adjunctive diode laser irradiation immediately after surgery or conventional postoperative care alone. Postoperative pain will be assessed using a visual analog scale, while clinical parameters related to wound healing, including bleeding tendency, epithelialization, and wound size reduction, will be evaluated at predefined follow-up time points. The findings of this study may contribute to the clinical understanding of photobiomodulation in free gingival graft surgery.
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)
盲法说明
Periodontal surgeries are performed by a periodontist with more than 20 years of clinical experience, who is not involved in laser irradiation or clinical outcome assessment. Laser irradiation and digital scanning of the palatal wound area are performed by a trained investigator who does not participate in clinical outcome evaluation. Clinical assessments and measurements of scanned images are conducted by an independent periodontist who is blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥18 years of age;
- •systemically healthy individuals without any conditions that could affect wound healing (e.g., diabetes, immunosuppression, coagulation disorders, Candida infection;
- •full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) <15%;
- •no previous history of palatal tissue harvesting;
- •no use of overdentures or partial dentures covering the donor area.
排除标准
- •pregnant or breastfeeding women;
- •patients with psychiatric disorders; and
- •patients taking any medications that impair tissue healing and affect pain perception.
结局指标
主要结局
Postoperative pain
时间窗: 2 hours, 3 days, and 7 days after surgery
Zero is equivalent to no pain and 10 indicates the worst possible pain.
Post-surgical analgesic consumption
时间窗: Within 3 days after surgery
The number of 500-mg acetaminophen tablets consumed by participants during the first 3 days after surgery.
Remaining wound area
时间窗: Immediately after surgery, and 3, 7, and 14 days after surgery
Changes in palatal donor site wound area measured using serial intraoral digital scans obtained at predefined follow-up time points
Epithelialization of the palatal donor site
时间窗: Day 7 and 14 after surgery
Epithelialization at the palatal donor site assessed as a binary outcome (yes/no) using a hydrogen peroxide bubbling test, classified as non-epithelialized (presence of bubbles) or completely epithelialized (absence of bubbles).
次要结局
未报告次要终点
研究者
Le Thanh Nguyen
Resident Physician, Department of Periodontics, University of Dentistry, HCMC
University of Medicine and Pharmacy at Ho Chi Minh City