Psychological and Clinical Outcomes of Splint Therapy with and Without Doctor-Patient Communication in TMD Management

Soaad Tolba Mohammed Tolba Badawi

Status: Completed

Conditions: Temporomandibular Disorders (TMDs)

Treatments: Device: Splint Therapy; Behavioral: Splint Therapy with Enhanced Doctor-Patient Communication

Study type: Interventional

Funder types: Other

Identifiers

NCT06783530

A02012024OS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 435 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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435 participants in 2 patient groups

Splint Therapy with Enhanced Doctor-Patient Communication

Experimental group

Description:

Participants in this arm received splint therapy along with structured doctor-patient communication to improve treatment outcomes.

Treatment:

Behavioral: Splint Therapy with Enhanced Doctor-Patient Communication

Standard Splint Therapy

Active Comparator group

Description:

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.

Treatment:

Device: Splint Therapy