Functional Aesthetic Therapy Integrating Cranio-Cervical Soft Tissue Manipulation, Myofunctional Exercises, Lymphatic Drainage, and Postural Breathing for Facial Glow, Orofacial Alignment, Pain Reduction, and Improved Oral Function in Patients with Temporomandibular Disorders: A Patient-Reported Outcome Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Dr Ramesh Chandra Patra
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The primary outcomes of this study include changes in pain intensity measured using the Visual Analogue Scale (VAS), changes in oral function assessed through the Jaw Functional Limitation Scale (JFLS), and evaluation of orofacial alignment using clinical assessment and standardized photographs. Additionally, patient-reported satisfaction with facial glow will be measured using a Likert scale.
概览
简要总结
Temporomandibular Disorders (TMD) affect jaw function, cause chronic pain, and may negatively impact facial aesthetics and quality of life. Conventional treatments often focus on pain reduction but rarely address aesthetic concerns or cranio cervical dysfunctions. This randomized controlled trial will evaluate the effectiveness of Functional Aesthetic Therapy, an integrated rehabilitation program combining cranio cervical soft tissue manipulation, orofacial myofunctional therapy, facial lymphatic drainage, and postural breathing exercises. Adult participants aged 18 to 60 years with TMD diagnosed according to DC TMD criteria and chronic orofacial pain lasting more than three months will be enrolled and randomized into two groups. The intervention group will undergo 30-minute Functional Aesthetic Therapy sessions twice weekly for six weeks, while the control group will receive standard conservative care consisting of education, warm compress, and jaw exercises. Primary outcomes include changes in pain intensity measured by the Visual Analogue Scale, oral function assessed with the Jaw Functional Limitation Scale, orofacial alignment evaluated through clinical and photographic assessments, and patient satisfaction with facial glow. Secondary outcomes include quality of life assessed by OHIP-14, anxiety and depression measured by HADS, and monitoring of adverse events for safety evaluation. This study will provide patient-reported outcome-based evidence for a novel multidisciplinary TMD rehabilitation strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Adults diagnosed with Temporomandibular Disorders (TMD) based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) will be eligible for the study.
- •Participants must have experienced chronic orofacial pain for more than three months and demonstrate willingness to provide informed consent and comply with all study procedures.
排除标准
- •Individuals with a history of orofacial surgery or trauma within the past six months, neurological disorders affecting facial muscles, or those currently undergoing orthodontic treatment or using occlusal splint therapy will be excluded.
- •Participants with severe psychiatric illness or those unable to complete study questionnaires, as well as pregnant or lactating women, will also not be eligible for inclusion in the study.
结局指标
主要结局
The primary outcomes of this study include changes in pain intensity measured using the Visual Analogue Scale (VAS), changes in oral function assessed through the Jaw Functional Limitation Scale (JFLS), and evaluation of orofacial alignment using clinical assessment and standardized photographs. Additionally, patient-reported satisfaction with facial glow will be measured using a Likert scale.
时间窗: Baseline, Week 3, Week 6 (end of treatment), 1-month follow-up.
次要结局
- Secondary outcomes include assessment of quality of life using the Oral Health Impact Profile (OHIP-14), evaluation of anxiety and depression levels with the Hospital Anxiety and Depression Scale (HADS), and monitoring of the intervention’s safety profile through systematic reporting of any adverse events.(Baseline, Week 3, Week 6 (end of treatment), 1-month follow-up.)
研究者
Dr Ramesh Chandra Patra
Lovely Professional University Faculty of Applied Medical Sciences