Temporomandibular Disorders (TMDs)
Conditions
Keywords
Splint Therapy, Doctor-Patient Communication, Non-Surgical TMD Treatment, TMDs management
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSplint Therapy with Enhanced Doctor-Patient Communication
A structured communication protocol aimed at improving doctor-patient interaction and treatment adherence.
DEVICESplint Therapy
A custom-fitted occlusal splint designed to alleviate symptoms of temporomandibular disorders (TMD).
Sponsors
Soaad Tolba Mohammed Tolba Badawi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
This study used a parallel assignment model with two groups: one receiving standard splint therapy and the other receiving splint therapy with enhanced doctor-patient communication.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression, Anxiety, and Stress levels | 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 | 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) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Masticatory Muscle Pain Intensity | Baseline to 6 months. | Pain intensity in the masticatory muscles (e.g., masseter, temporalis, medial pterygoid, lateral pterygoid) was assessed by palpation at specific points, which uses a pain scale from zero to three (0: pressure only; 1: mild pain; 2: moderate pain; 3: severe pain). Pain assisted by palpation pressure (1kg pressure for 5sec) as defined in DC/TMD. |
| Patient Satisfaction with Treatment | From 6 months to 1-year post-intervention. | Each patient was evaluated at 6 and 12 months after intervention. The patient satisfaction questionnaire comprised two questions assessed using a 10-point Likert scale (1 = extremely dissatisfied to 10 = perfect/strongly satisfied). * Overall satisfaction with the clinical result of the treatment. * Satisfaction with the fulfillment of postoperative expectations. |
Countries
Egypt
Outcome results
None listed