Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-01-01 @ 10:12 AM
Study NCT ID:
NCT07074366
Status:
COMPLETED
Last Update Posted:
2025-07-20
First Post:
2025-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
How Dentists' Personality Traits Affect Communication and Treatment Outcomes in TMD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2025-07-10', 'studyFirstSubmitQcDate': '2025-07-10', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-Centered Communication Score (PCCS)', 'timeFrame': '6 months post-treatment', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Patient Satisfaction with Treatment', 'timeFrame': '6 months post-treatment', 'description': 'Patient satisfaction was measured using a structured questionnaire developed to assess overall satisfaction with the treatment process, fulfillment of expectations, and perceived treatment effectiveness. Responses were scored on a Likert scale, with higher scores indicating greater satisfaction.'}, {'measure': 'Adherence to Splint Therapy', 'timeFrame': '6 months post-treatment', 'description': 'Patient adherence was assessed using two self-reported indicators: (1) average number of hours per day the splint was worn, and (2) number of days per week the splint was used consistently. Higher scores reflect better adherence.'}, {'measure': 'Change in Psychological Distress (DASS-10 Score)', 'timeFrame': 'Baseline and 6 months post-treatment', 'description': 'Psychological distress was measured using the 10-item Depression, Anxiety, and Stress Scale (DASS-10). The change in score from baseline to 6-month follow-up reflects improvement or worsening of psychological wellbeing.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TMD', 'Splint Therapy', 'Dentist Personality', 'Patient Satisfaction'], 'conditions': ['Temporomandibular Disorders', 'Psychological Distress', 'Chronic Orofacial Pain']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': 'Temporomandibular disorders are multifactorial conditions often accompanied by psychological distress, chronic pain, and functional limitations. While splint therapy remains a common conservative intervention, patient adherence and satisfaction with treatment can vary widely and are often influenced by interpersonal dynamics between provider and patient.\n\nEmerging literature in medicine and dentistry suggests that provider personality traits play a critical role in shaping communication style, patient engagement, and ultimately clinical outcomes. However, few studies have systematically examined this relationship within dental practice, particularly in the management of TMDs.\n\nThis study adopts a prospective, randomized design. Thirty dentists treating TMD patients are assessed for their personality traits using the BFI-2-S, which evaluates five core dimensions: conscientiousness, agreeableness, extraversion, openness, and negative emotionality. Three hundred TMD patients are randomly assigned to one of the participating dentists and undergo a standardized treatment protocol involving splint therapy. Dentists follow a structured communication and counseling framework aimed at enhancing the quality of interaction and patient education.\n\nPatient outcomes are assessed at baseline and after six months of therapy. The key outcomes include:\n\nQuality of doctor-patient communication, measured using the PCCS,\n\nTreatment satisfaction using a structured questionnaire,\n\nAdherence to splint therapy (hours/day and days/week),\n\nPsychological well-being measured by the DASS-10.\n\nStatistical analyses include correlation to assess the association between dentist personality traits and patient outcomes.\n\nThis study has the potential to uncover meaningful links between provider personality and clinical success in TMD management. Results may guide the development of more effective communication protocols, inform training and self-awareness initiatives for dental professionals, and promote patient-centered care grounded in both technical and interpersonal excellence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Eligibility criteria for dentists included:\n\n* Had at least two years of clinical experience in the management of TMDs.\n* Were actively involved in the clinical care of TMD patients at the time of the study.\n* Willingness to participate and complete the BFI-2-S personality assessment.\n\nEligibility criteria for patients included:\n\nInclusion Criteria:\n\n* Diagnosed with TMDs according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) guidelines, specifically disc displacement with reduction.\n* Exhibiting symptoms of stress or anxiety, as identified by the baseline DASS-10 screening.\n* Prescribed occlusal splint therapy as part of their treatment regimen.\n\nExclusion Criteria:\n\n* Cognitive impairments.\n* Psychiatric conditions other than anxiety or depression.\n* Any condition that could impair the patient's ability to provide informed consent or accurately complete self-report questionnaires."}, 'identificationModule': {'nctId': 'NCT07074366', 'acronym': 'TMD', 'briefTitle': "How Dentists' Personality Traits Affect Communication and Treatment Outcomes in TMD Patients", 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Personality Traits of TMD Experts Really Matters, A New Era in TMD Management', 'orgStudyIdInfo': {'id': 'RP.25.05.1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TMD Patients Assigned to Dentists', 'description': '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.', 'interventionNames': ['Behavioral: Splint Therapy with Structured Communication']}], 'interventions': [{'name': 'Splint Therapy with Structured Communication', 'type': 'BEHAVIORAL', 'description': 'All participants received a stabilization splint for the management of TMDs, combined with a structured counseling protocol delivered by the assigned dentist.', 'armGroupLabels': ['TMD Patients Assigned to Dentists']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35511', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Soaad Tolba Badawy, Lecturer, Oral Surgery, MU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of dentistry, Mansoura university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soaad Tolba Mohammed Tolba Badawi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Oral and Maxillofacial Surgery', 'investigatorFullName': 'Soaad Tolba Mohammed Tolba Badawi', 'investigatorAffiliation': 'Mansoura University'}}}}