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

January 14, 2025 updated by: Soaad Tolba Mohammed Tolba Badawi

Psychological and Clinical Outcomes After Splint Therapy with Versus Without Doctor-patient Communication Concept in the Management of TMDs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

435

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516
        • Faculty of Dentistry, Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Splint Therapy with Enhanced Doctor-Patient Communication
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
A structured communication protocol aimed at improving doctor-patient interaction and treatment adherence.
Active Comparator: 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.
Device: Splint Therapy
A custom-fitted occlusal splint designed to alleviate symptoms of temporomandibular disorders (TMD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression, Anxiety, and Stress levels
Time Frame: 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.
Baseline to 6 months.
Change in Interincisal Mouth Opening
Time Frame: Baseline to 6 months.
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)
Time Frame: 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).
Baseline to 6 months.
Change in Joint Sound Presence and Characteristics
Time Frame: 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.
Baseline to 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Masticatory Muscle Pain Intensity
Time Frame: 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.
Baseline to 6 months.
Patient Satisfaction with Treatment
Time Frame: 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.
From 6 months to 1-year post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soaad Tolba Mohammed Tolba Badawi

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Actual)

October 15, 2024

Study Completion (Actual)

October 30, 2024

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A02012024OS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

At this time, no decision has been made regarding the sharing of Individual Participant Data (IPD). Data-sharing plans will be determined based on institutional guidelines, ethical considerations, and journal requirements at the time of publication.

Study Data/Documents

  1. Study Protocol
    Information comments: Faculty of Dentistry, Mansoura University - Ethical Committee Information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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