NCT07074366

Brief Summary

This prospective, longitudinal study investigates the influence of dentists' personality traits on patient-reported outcomes among individuals with temporomandibular disorders (TMDs) undergoing splint therapy. Dentists are assessed using the Big Five Inventory-2 Short Form (BFI-2-S), and patients are randomly assigned to them. Key outcomes measured six months after treatment include patient-centered communication, treatment satisfaction, adherence to splint therapy, and changes in psychological distress using validated scales such as the Patient-Centered Communication Scale (PCCS), a structured satisfaction questionnaire, and the DASS-10. The study explores whether traits such as conscientiousness, agreeableness, extraversion, openness, and emotional stability are associated with better patient outcomes in TMD care. This research aims to enhance patient-centered treatment by integrating personality-informed clinical practice and tailored communication strategies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 20, 2025

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

1.3 years

First QC Date

July 10, 2025

Last Update Submit

July 10, 2025

Conditions

Keywords

TMDSplint TherapyDentist PersonalityPatient Satisfaction

Outcome Measures

Primary Outcomes (1)

  • Patient-Centered Communication Score (PCCS)

    Patient-centered communication was assessed using the validated Patient-PCCS. This self-reported measure evaluates the quality of dentist-patient communication from the patient's perspective, including aspects such as empathy, clarity, and involvement in decision-making. Scores range from low to high, with higher scores indicating more patient-centered communication. The outcome is used to determine the influence of dentist personality traits on perceived communication quality.

    6 months post-treatment

Secondary Outcomes (3)

  • Patient Satisfaction with Treatment

    6 months post-treatment

  • Adherence to Splint Therapy

    6 months post-treatment

  • Change in Psychological Distress (DASS-10 Score)

    Baseline and 6 months post-treatment

Study Arms (1)

TMD Patients Assigned to Dentists

Patients diagnosed with TMDs were randomly assigned to dentists with varying personality traits. All patients received standardized splint therapy and were followed for six months. Key patient-reported outcomes-including communication quality, satisfaction with treatment, adherence to splint use, and changes in psychological distress (DASS-10)-were assessed to examine the influence of dentist personality on treatment effectiveness.

Behavioral: Splint Therapy with Structured Communication

Interventions

All participants received a stabilization splint for the management of TMDs, combined with a structured counseling protocol delivered by the assigned dentist.

TMD Patients Assigned to Dentists

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study included adult patients diagnosed with TMDs seeking care at the oral and maxillofacial surgery department of Faculty of dentistry, Mansoura university. All patients were eligible for splint therapy and were randomly assigned to postgraduate dentists with advanced clinical training in TMD management. Dentists were with advanced training in TMD management. Participants were followed for six months after the initiation of treatment.

You may qualify if:

  • Diagnosed with TMDs according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) guidelines, specifically disc displacement with reduction.
  • Exhibiting symptoms of stress or anxiety, as identified by the baseline DASS-10 screening.
  • Prescribed occlusal splint therapy as part of their treatment regimen.

You may not qualify if:

  • Cognitive impairments.
  • Psychiatric conditions other than anxiety or depression.
  • Any condition that could impair the patient's ability to provide informed consent or accurately complete self-report questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint DisordersPatient Satisfaction

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Soaad Tolba Badawy, Lecturer, Oral Surgery, MU

    Faculty of dentistry, Mansoura university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

July 10, 2025

First Posted

July 20, 2025

Study Start

December 1, 2023

Primary Completion

April 1, 2025

Study Completion

June 1, 2025

Last Updated

July 20, 2025

Record last verified: 2025-07

Locations