Clinical trial NCT06783530: Psychological and Clinical Outcomes of Splint Therapy with and Without Doctor-Patient Communication in TMD Management
Official title: Psychological and Clinical Outcomes After Splint Therapy with Versus Without Doctor-patient Communication Concept in the Management of TMDs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorders (TMDs)
Keywords: Splint Therapy
Doctor-Patient Communication
Non-Surgical TMD Treatment
TMDs management
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 435
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Depression, Anxiety, and Stress levels
timeFrame: Baseline to 6 months.
measure: Change in Interincisal Mouth Opening
timeFrame: Baseline to 6 months.
measure: Change in Intra-articular pain (IAP)
timeFrame: Baseline to 6 months.
measure: Change in Joint Sound Presence and Characteristics
timeFrame: Baseline to 6 months.
Secondary outcomes:
measure: Change in Masticatory Muscle Pain Intensity
timeFrame: Baseline to 6 months.
measure: Patient Satisfaction with Treatment
timeFrame: From 6 months to 1-year post-intervention.
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry, Mansoura University
state: Dakahlia
Study officials:
affiliation: Faculty of dentistry, Mansoura university
name: Soaad Tolba Badawy, Lecturer of OMFS, MU
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of dentistry, Mansoura university
name: Mai Ahmed Haggag, Assistant Professor of OMFS
role: PRINCIPAL_INVESTIGATOR
affiliation: Prosthodontics Department, Faculty of dentistry, Mansoura university
name: Christine Raouf Micheal, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Barros Pascoal AL, de Freitas RFCP, da Silva LFG, Oliveira AGRC, Dos Santos Calderon P. Effectiveness of Counseling on Chronic Pain Management in Patients with Temporomandibular Disorders. J Oral Facial Pain Headache. 2020 Winter;34(1):77-82. doi: 10.11607/ofph.2163. Epub 2019 Apr 12.