Internal Photobiomodulation For Management Of Temporomandibular Joint Internal Derangement: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain level assessment using Visual Analogue Scale
研究概览
简要总结
Aim of the study was to compare the efficacy of internal versus external photobiomodulation (PBM) in the management of patients with TMJ internal derangements (TMJ-ID).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Painful click at temporomandibular joint (TMJ) area.
- •Pain at the lateral pterygoid muscle.
- •Presence of full or nearly full complement of natural teeth with acceptable occlusion
排除标准
- •Patients who have radiographic evidence of degenerative conditions of TMJ.
- •Patients under current dental or physical therapy that could affect TMD.
- •History of recent trauma.
- •The presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis).
- •Pregnant and lactating females.
- •Presence of open bite.
研究组 & 干预措施
External low level laser therapy
干预措施: External low level laser therapy (Device)
Internal low level laser therapy
干预措施: Internal low level laser therapy (Device)
结局指标
主要结局
Pain level assessment using Visual Analogue Scale
时间窗: after one month from the last laser session
All patients will be evaluated subjectively through Visual Analogue Scale (VAS) to clinically assess the pain intensity with ratings between 0 for pain-free and 10 for maximum pain
Oral health-related quality of life using OHIP-TMD
时间窗: after one month from the last laser session
Oral health-related quality of life will be assessed using OHIP-TMD, a 22-item temporomandibular disorder-specific version of the Oral Health Impact Profile (OHIP). Each item in the OHIP-TMDs is scored on a Likert scale, often ranging from: 0 (Never) to 4 (Very often). For each respondent, the scores for all 22 items are summed to create a total score. The total score ranges from 0 to 88, where higher scores indicate a greater negative impact on oral health-related quality of life.
Maximum mouth opening evaluation using the Miller index
时间窗: after one month from the last laser session
The Miller Index is calculated as a ratio of the observed maximum interincisal distance (distance between the edges of the upper and lower incisors when the mouth is fully open) to the patient's height. This provides a normalized measure of mouth opening relative to body stature. Miller Index= Maximum Interincisal Distance (mm)/Height (cm) Normal Range: A typical Miller Index is around 1.6 to 1.7 mm/cm in healthy individuals. This means that for every centimeter of height, the expected mouth opening is about 1.6 to 1.7 mm. Deviations: * Lower than Normal: May indicate restricted mouth opening (e.g., trismus, TMDs, fibrosis, ankylosis). * Higher than Normal: May occur in conditions involving hypermobility.
次要结局
未报告次要终点
研究者
Nourhan M.Aly
Assistant Lecturer of Dental Public Health
University of Alexandria