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

NCT ID: NCT06783530

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 435 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-10-30

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.

Conditions

Temporomandibular Disorders (TMDs)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Splint Therapy with Enhanced Doctor-Patient Communication

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

Group Type: EXPERIMENTAL

Splint Therapy with Enhanced Doctor-Patient Communication

Intervention Type: BEHAVIORAL

A structured communication protocol aimed at improving doctor-patient interaction and treatment adherence.

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.

Group Type: ACTIVE_COMPARATOR

Splint Therapy

Intervention Type: DEVICE

A custom-fitted occlusal splint designed to alleviate symptoms of temporomandibular disorders (TMD).

Interventions

Splint Therapy with Enhanced Doctor-Patient Communication

A structured communication protocol aimed at improving doctor-patient interaction and treatment adherence.

Intervention Type: BEHAVIORAL

Splint Therapy

A custom-fitted occlusal splint designed to alleviate symptoms of temporomandibular disorders (TMD).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soaad Tolba Mohammed Tolba Badawi

OTHER

Sponsor Role: lead

Responsible Party

Soaad Tolba Mohammed Tolba Badawi

lecturer of oral and maxillofacial department, faculty of dentistry, Mansoura university

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Soaad Tolba Badawy, Lecturer of OMFS, MU

Role: PRINCIPAL_INVESTIGATOR

Faculty of dentistry, Mansoura university

Mai Ahmed Haggag, Assistant Professor of OMFS

Role: PRINCIPAL_INVESTIGATOR

Faculty of dentistry, Mansoura university

Christine Raouf Micheal, Assistant Professor

Role: PRINCIPAL_INVESTIGATOR

Prosthodontics Department, Faculty of dentistry, Mansoura university

Locations

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 30978270 (View on PubMed)

Haggag MA, Ibrahim CRM, Badawy ST. Psychological and Clinical Outcomes After Splint Therapy With Versus Without Doctor-Patient Communication Concept in the Management of TMDs: A Randomised Controlled Clinical Trial. J Oral Rehabil. 2025 Oct;52(10):1651-1663. doi: 10.1111/joor.14005. Epub 2025 May 19.

Reference Type: DERIVED

PMID: 40384540 (View on PubMed)

Study Documents

Document Type: Study Protocol

Faculty of Dentistry, Mansoura University - Ethical Committee Information.

View Document

Related Links

https://pubmed.ncbi.nlm.nih.gov/?term=splint+therapy+for+temporomandibular+disorders.%22

This link provides a collection of research articles related to splint therapy for temporomandibular disorders, which aligns with the focus of this study.

https://pubmed.ncbi.nlm.nih.gov/?term=counselling+for+temporomandibular+disorders.%22

This link directs to a PubMed search for studies related to counselling as a treatment approach for temporomandibular disorders, which is relevant to this study's objectives.

Other Identifiers

A02012024OS

Identifier Type: -

Identifier Source: org_study_id