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NCT Number: NCT06783530

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

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.

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Key information

Conditions

Temporomandibular Disorders (TMDs) Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Splint Therapy with Enhanced Doctor-Patient Communication

Behavioral

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

Splint Therapy

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Soaad Tolba Mohammed Tolba Badawi

Other

Registry information

Official study title

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

Acronym: TMD

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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