Psychological and Clinical Outcomes After Splint Therapy with Versus Without Doctor-patient Communication Concept in the Management of TMDs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 435
- 试验地点
- 1
- 主要终点
- Change in Depression, Anxiety, and Stress levels
研究概览
简要总结
This study aimed to evaluate the psychological and clinical outcomes of patients undergoing splint therapy with or without enhanced doctor-patient communication in the management of temporomandibular disorders (TMDs). The study compared treatment approaches to determine their impact on patient satisfaction and clinical results.
详细描述
Temporomandibular disorders (TMDs) are prevalent conditions characterized by jaw pain, functional limitations, and psychological distress. This study investigated the impact of splint therapy combined with enhanced doctor-patient communication on psychological well-being and clinical outcomes. Participants were randomly assigned to receive standard splint therapy or splint therapy with additional doctor-patient communication strategies. The primary outcomes include clinical and psychological status improvements, measured over six months, and patient satisfaction, assessed over a one-year period. The results aimed to provide insights into optimizing treatment strategies for TMD patients.
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)
盲法说明
The allocation was concealed from participants and the statistician performing the data analysis to minimize bias. However, the clinician administering the intervention was aware of the patient's allocation to ensure appropriate treatment delivery.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients complaining of pain in the orofacial region (either arthrogenous and/or myogenous TMD) in the last 3 months, who never underwent any type of treatment for TMD's.
- •Age ≥16 years.
排除标准
- •patients who have already undergone any treatment for TMD's, edentulous patients,
- •patients with any systemic disease that could cause joint and/or muscle changes,
- •patients who were undergoing drug treatment for the condition, current pregnancy, or breastfeeding.
研究组 & 干预措施
Splint Therapy with Enhanced Doctor-Patient Communication
Participants in this arm received splint therapy along with structured doctor-patient communication to improve treatment outcomes.
干预措施: Splint Therapy with Enhanced Doctor-Patient Communication (Behavioral)
Standard Splint Therapy
Participants in this group received standard splint therapy for the management of temporomandibular disorders (TMD). The splint was fitted and adjusted by a qualified clinician, and participants was monitored for outcomes such as pain reduction, jaw function, and patient satisfaction.
干预措施: Splint Therapy (Device)
结局指标
主要结局
Change in Depression, Anxiety, and Stress levels
时间窗: Baseline to 6 months.
Depression, anxiety, and stress levels was measured using the 10-item Depression, Anxiety, and Stress Scale (DASS-10) at baseline and after six months of therapy. The DASS-10 comprises 10 items, each rated on a 4-point Likert scale ranging from 0 ("Did not apply to me at all") to 3 ("Applied to me very much or most of the time"). * Minimum value: 0 * Maximum value: 30 * Interpretation: Higher scores indicate worse psychological outcomes.
Change in Interincisal Mouth Opening
时间窗: Baseline to 6 months.
Maximum interincisal mouth opening was measured at baseline and after six months of therapy using a calibrated caliper.
Change in Intra-articular pain (IAP)
时间窗: Baseline to 6 months.
Intra-articular pain was assessed at baseline and after six months using the Visual Analog Scale (VAS) for pain intensity. The scale ranged from 0 to 10, where: * Minimum value: 0 (No pain) * Maximum value: 10 (Worst possible pain).
Change in Joint Sound Presence and Characteristics
时间窗: Baseline to 6 months.
Joint Sounds were measured in scores from 0 to 5, where 0 = no joint sound, 1 = Joint noise on occasion, 2 = palpable clicking, 3 = audible clicking, 4 = absence of previous clicking (closed lock), and 5 = crepitation. Assessment of the presence and characteristics of joint sounds was performed at baseline and after six months of therapy.
次要结局
- Change in Masticatory Muscle Pain Intensity(Baseline to 6 months.)
- Patient Satisfaction with Treatment(From 6 months to 1-year post-intervention.)
研究者
Soaad Tolba Mohammed Tolba Badawi
lecturer of oral and maxillofacial department, faculty of dentistry, Mansoura university
Mansoura University