The Efficacy of Low-level Laser Therapy (LLLT) as an Adjunct Treatment for Pain and Functional Outcomes in Temporomandibular Disorders (TMD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain: VAS score
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of low-level laser therapy (LLLT) as an adjunct treatment in patients aged 18 years and older diagnosed with temporomandibular disorders (TMD).
The main questions it aims to answer are:
- Does LLLT improve pain intensity during muscle palpation and mandibular movements?
- Does LLLT improve functional outcomes, such as maximum mouth opening, lateral excursions, and protrusive movements?
Researchers will compare active LLLT alongside conservative treatment to a sham laser with conservative treatment to see if the active laser provides significantly greater reductions in pain and improvements in jaw function.
Participants will follow a standardized conservative treatment protocol, which includes taking ibuprofen and muscle relaxants, applying moist heat therapy, and eating a soft diet. Receive either an active laser treatment or a sham (placebo) laser treatment on identified tender points for 38 seconds per point, given in six sessions over two weeks. Undergo pain and functional assessments at baseline, after each treatment session, and at Day 14 and Day 30 follow-up visits.
详细描述
This randomized controlled trial included 30 patients diagnosed with TMD based on Axis I of the DC/ TMD criteria. Participants were allocated into two groups: 15 received LLLT alongside conservative treatment, while 15 received sham laser with conservative treatment. Pain was evaluated using the Visual Analogue Scale (VAS) during palpation and mandibular movement, while function was evaluated by measuring mouth opening, lateral excursions and protrusion. The LLLT group was treated with a 940 nm diode laser (10 J/cm2, 0.3 W, 1.13 cm2 spot size) applied to tender points for 38 seconds per point over six sessions within two weeks. The placebo group received sham laser application. Assessments were conducted at baseline, after each session and at Day 14 and Day 30 follow-ups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Patients aged 18 and above
- •Patients diagnosed with TMD utilizing Axis I of the DC/TMD
- •Patients diagnosed with TMD irrespective of the severity as screened utilizing the Fonseca Anamnestic Index (FAI) questionnaire form (APPENDIX D)
- •American Association of Anesthesiologists (ASA) Physical Status Classification I-II
- •Class I occlusion/malocclusion
- •Natural dentition patient with at least one pair of occluding posterior teeth on each side of the mandible
排除标准
- •Patients who refuse participation/do not consent to the study
- •Patients presenting with any lesion or pathology over the TMJ region
- •Patients presented with TMD-like signs and symptoms secondary to non-TMJ origin (pain or infection of odontogenic origin, ear origin, neuralgia, migraine, atypical facial pain, etc.)
- •Patients that are presented with active infection involving the orofacial region
- •Patients with psychiatric and neurological disorders as confirmed by medical practitioners.
- •Patients with systemic or autoimmune disorders affecting the masticatory system, bones, and joints (rheumatoid arthritis, osteoarthritis)
- •Patients that are contraindicated for the use of LLLT (malignant disease, ongoing radiotherapy, thyroid gland disease, epilepsy, light sensitivity, hemophilia, and other blood and clotting diseases, etc.)
- •TMD patients receiving physical or psychological treatment, and those who have been using muscle relaxants, anti-inflammatory agents (for at least seven days before study begins) or an occlusal appliance
- •Patients with a history of facial bone fractures
- •Patients on fixed orthodontic appliances, history of orthognathic surgery, or TMJ surgery
- •Patients with occlusal interferences, removable partial or total denture wearers, and fixed prostheses that are affecting patients' occlusion
- •Patients with an allergy to, or contraindication for, the use of NSAIDs
- •Pregnant patients
研究组 & 干预措施
Patients with TMDs
The LLLT group was treated with a 940 nm diode laser (10 J/cm2, 0.3 W, 1.13 cm2 spot size) applied to tender points for 38 seconds per point over six sessions within two weeks
干预措施: LLLT (Device)
Patient with TMDs + Sham treatment
Patients with TMDs and given Sham treatment
干预措施: Sham (No LLLT) (Procedure)
结局指标
主要结局
Pain: VAS score
时间窗: Assessments were conducted at baseline, after each treatment session (S1 - S6) [three times weekly for two weeks], and at follow-up on Day 14 (D14) and Day 30 (D30) post-treatment.
Visual Analogue Scale (VAS): score 0 (no pain) to 10 (maximum pain) during muscle palpation and mandibular movement
次要结局
- Maximum pain-free mouth opening(Assessments were conducted at baseline, after each treatment session (S1 - S6), and at follow-up on Day 14 (D14) and Day 30 (D30) post-treatment.)
- Maximum mouth opening with pain, unassisted(Assessments were conducted at baseline, after each treatment session (S1 - S6), and at follow-up on Day 14 (D14) and Day 30 (D30) post-treatment.)
- d) Maximum assisted mouth opening(Assessments were conducted at baseline, after each treatment session (S1 - S6), and at follow-up on Day 14 (D14) and Day 30 (D30) post-treatment.)
- Right and Left lateral movement(Assessments were conducted at baseline, after each treatment session (S1 - S6), and at follow-up on Day 14 (D14) and Day 30 (D30) post-treatment.)
- Protrusive mandibular movement(Assessments were conducted at baseline, after each treatment session (S1 - S6), and at follow-up on Day 14 (D14) and Day 30 (D30) post-treatment.)
研究者
Tan Chuey Chuan
A/P DR
University of Malaya