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

NCT06783530 | Completed

• 1 other identifier: A02012024OS
• Study Type: interventional
• Target: 435
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorders (TMDs)

Keywords

Splint Therapy; Doctor-Patient Communication; Non-Surgical TMD Treatment; TMDs management

Outcome Measures

Primary Outcomes (4)

• Change in Depression, Anxiety, and Stress levels

  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.

  Baseline to 6 months.

• Change in Interincisal Mouth Opening

  Maximum interincisal mouth opening was measured at baseline and after six months of therapy using a calibrated caliper.

  Baseline to 6 months.

• Change in Intra-articular pain (IAP)

  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).

  Baseline to 6 months.

• Change in Joint Sound Presence and Characteristics

  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.

  Baseline to 6 months.

Secondary Outcomes (2)

• Change in Masticatory Muscle Pain Intensity

  Baseline to 6 months.

• Patient Satisfaction with Treatment

  From 6 months to 1-year post-intervention.

Study Arms (2)

Splint Therapy with Enhanced Doctor-Patient Communication

EXPERIMENTAL

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

Behavioral: Splint Therapy with Enhanced Doctor-Patient Communication

Standard Splint Therapy

ACTIVE COMPARATOR

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.

Device: Splint Therapy

Interventions

Splint Therapy with Enhanced Doctor-Patient Communication BEHAVIORAL

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

Splint Therapy with Enhanced Doctor-Patient Communication

Splint Therapy DEVICE

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

Standard Splint Therapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Soaad Tolba Mohammed Tolba Badawi: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Related Publications (2)

• 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.

  PMID: 30978270 BACKGROUND

• 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.

  PMID: 40384540 DERIVED

Related Links

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

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Soaad Tolba Badawy, Lecturer of OMFS, MU

  Faculty of dentistry, Mansoura university

  PRINCIPAL INVESTIGATOR

• Mai Ahmed Haggag, Assistant Professor of OMFS

  Faculty of dentistry, Mansoura university

  PRINCIPAL INVESTIGATOR

• Christine Raouf Micheal, Assistant Professor

  Prosthodontics Department, Faculty of dentistry, Mansoura university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer of oral and maxillofacial department, faculty of dentistry, Mansoura university

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 20, 2025
• Study Start: July 1, 2023
• Primary Completion: October 15, 2024
• Study Completion: October 30, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

EG (1)