Evaluation of Temporomandibular Joint Condition Post Longstanding Mouth Opening by Rubber Dam (A Clinical and Radiographic Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
This Clinical and radiographic study will be designed to evaluate the temporomandibular joint condition post longstanding mouth opening during dental procedure using rubber dam. primary outcome : preoperative and postoperative assessment of interincisal distance , occlusal biting force , visual analogue scale , lateral excursion movement and Magnetic resonance imaging (MRI).
Secondary outcome: investigator will try to answer the question of what is the best duration of time could the dentist use rubber dam isolation in dental procedures without harmful effect on TMJ and its supporting structures?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged from 18 - 40 years old of both sexes.
- •No evidence of bad habits that affect occlusion like bruxism or clenching.
- •Patient with normal occlusion.
- •Patient free of any signs and symptoms of TMD and myofascial pain.
- •Normal range of TMJ movements.
- •Normal biting force.
排除标准
- •Patient with systemic or local diseases that can affect TMJ like osteoarthritis, rheumatoid arthritis, or systemic lupus erythema.
- •Patient with trismus.
- •Patient with Recurrent dislocation of TMJ.
- •Swelling affects mouth opening.
- •Patient came with TMJ ankylosis.
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: Preoperative, immediately postoperative, 2 weeks postoperative.
A subjective measure of pain intensity experienced by the patient. Patients will mark their pain level on a scale from 0 (no pain) to 10 (worst pain imaginable).
Interincisal Distance
时间窗: Preoperative, immediately postoperative, 2 weeks postoperative.
Measurement of the distance from the incisal edge of upper incisors to the incisal edge of lower incisors when the mouth is opened maximally in mm.
Occlusal Biting Force
时间窗: Preoperative, immediately postoperative, 2 weeks postoperative.
measurement of the biting force exerted by the patient's occlusion. This will be measured using a bite force gauge or similar instrument at the specified time points.
Magnetic Resonance Imaging (MRI)
时间窗: 2 weeks postoperative (for symptomatic patients).
MRI scans will be done for patients who exhibit signs and symptoms of TMD postoperatively.
Lateral Excursion Movement
时间窗: Preoperative, immediately postoperative, 2 weeks postoperative.
The maximum amount of lateral excursion on each side will be measured in mm.
次要结局
- Optimal Duration for Rubber Dam Use(immediately postoperative)
研究者
Ahmed Sabry
Resident at Oral and Maxillofacial Surgery
Al-Azhar University