Comparison of the Clinical Effectiveness of Two Photobiomodulation Systems for Facial Nerve Dysfunction Following Temporomandibular Joint Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Sunnybrook Facial Grading System Score
研究概览
简要总结
This randomized clinical trial compared two photobiomodulation systems for the management of postoperative facial nerve dysfunction following temporomandibular joint surgery. Patients who developed clinically detectable facial nerve dysfunction after open temporomandibular joint surgery were randomly assigned to receive photobiomodulation using either the GRR Laser system or the SiroLaser Advance Plus system. Photobiomodulation was initiated on the first postoperative day and consisted of 15 treatment sessions. Facial nerve recovery was evaluated using the House-Brackmann Grading System, the Sunnybrook Facial Grading System, and the Facial Clinimetric Evaluation (FaCE) Scale during a 60-day follow-up period.
详细描述
This prospective, randomized, parallel-group clinical trial was conducted in patients who developed postoperative facial nerve dysfunction following open temporomandibular joint surgery. Eligible participants were randomly allocated in a 1:1 ratio to one of two active photobiomodulation treatment groups using a computer-generated block randomization sequence.
Participants assigned to the GRR Laser group received extraoral transcutaneous photobiomodulation using a dual-wavelength 650-nm and 904-nm laser/LED system. Participants assigned to the SiroLaser Advance Plus group received extraoral transcutaneous photobiomodulation using a 660-nm continuous-wave diode laser. In both groups, irradiation was applied along the anatomical projection of the clinically affected facial nerve branches on the operated side.
Photobiomodulation treatment was initiated on the first postoperative day. Treatment was administered daily during the first five postoperative days and every other day thereafter, for a total of 15 treatment sessions. Each treatment session lasted approximately 10 minutes.
Facial nerve function was evaluated on postoperative days 5, 7, 10, 30, and 60. Clinical assessments included the House-Brackmann Grading System and the Sunnybrook Facial Grading System. Patient-reported functional status and quality of life were assessed using the Facial Clinimetric Evaluation (FaCE) Scale. The first standardized outcome assessment was performed on postoperative day 5; therefore, this assessment represented the first standardized postoperative evaluation rather than a pretreatment baseline.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent open temporomandibular joint surgery.
- •Presence of clinically confirmed postoperative facial nerve dysfunction.
- •Willingness to comply with the follow-up protocol and attend scheduled follow-up visits.
- •Provision of written informed consent.
排除标准
- •Pre-existing facial nerve paralysis or facial nerve dysfunction before surgery.
- •History of central neurological disease.
- •Previous surgery involving the facial nerve.
- •History of head and neck malignancy and/or chemotherapy or radiotherapy that could potentially affect facial nerve function.
结局指标
主要结局
Change in Sunnybrook Facial Grading System Score
时间窗: From postoperative day 5 to postoperative day 60
The Sunnybrook Facial Grading System was used to assess facial nerve function based on resting symmetry, voluntary facial movement, and synkinesis. The composite score ranges from 0 to 100, with higher scores indicating better facial nerve function. The change score was calculated as the postoperative day 60 score minus the postoperative day 5 score.
次要结局
- House-Brackmann Grading System(Postoperative days 5, 7, 10, 30, and 60)
- Facial Clinimetric Evaluation (FaCE) Scale(Postoperative days 5, 7, 10, 30, and 60)
研究者
Mehmet Emre Yurttutan
Associate Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry
Ankara University