Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-31 @ 2:50 PM
Study NCT ID:
NCT07016256
Status:
COMPLETED
Last Update Posted:
2025-06-11
First Post:
2025-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Different Oral Splints on the Maximum Bite Force in TMD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D063806', 'term': 'Myalgia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '75 men and 75 women diagnosed with muscular TMD, dividen in 3 groups (25 patients each) to evaluate 3 different oral splints on the maximum bite force'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2025-06-03', 'studyFirstSubmitQcDate': '2025-06-03', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum bite force in the incisal and molar zones', 'timeFrame': 'From enrollment to 30 days after splint utilization', 'description': 'Each patient will be tested at the beginning of the clinical trial on the maximum bite force in the incisal zone, and after 30 days post splint utilization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TMD', 'oral splints', 'lucia jig', 'Sved splint', 'Occlusal splint', 'orofacial pain', 'muscular pain'], 'conditions': ['Muscular TMD']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate whether three different types of intraoral splints can increase maximal voluntary mandibular clenching force in adults diagnosed with myogenous temporomandibular disorders (TMD). The main questions it aims to answer are:\n\nDo intraoral splints enhance maximal clenching force in patients with muscle-related TMD? Is there a difference in the effectiveness of the three splint designs in improving muscle strength? Researchers will compare the effects of each splint within the same participants to determine which one most effectively increases clenching force.\n\nParticipants will:\n\nUndergo baseline assessment of maximal mandibular clenching force Use each intraoral splint for a 30-day period Complete follow-up assessments after each intervention phase', 'detailedDescription': 'This clinical trial aims to evaluate the effect of three different types of intraoral splints on maximal voluntary bite force in patients diagnosed with myogenous temporomandibular disorders (TMD). A total of 150 participants were recruited, consisting of 75 men and 75 women. Each gender group was evenly divided into three intervention arms:\n\n25 participants received the Lucia Jig splint 25 participants received the Sved splint 25 participants received the Occlusal splint All participants were previously diagnosed with muscle-related TMD by a qualified clinician. Each participant served as their own control. Baseline measurements of maximum bite force were recorded prior to the intervention using a gnatodynamometer (Kratos, Brazil). Measurements were taken in two anatomical zones: the incisal zone and the molar zone.\n\nFor each zone, three consecutive bite force measurements were recorded, with a 5-minute rest interval between each trial. The average of the three measurements was calculated and used as the baseline value for each zone.\n\nParticipants were instructed to use their assigned intraoral splint nightly for a period of 30 days. After this period, they returned for a follow-up assessment. The same measurement protocol was repeated: three bite force recordings in both the incisal and molar zones, each separated by a 5-minute interval. The average of these three post-intervention values was calculated for comparison with the baseline.\n\nThis within-subject design allows for the evaluation of changes in bite force attributable to each splint type, and for comparison across the three splint designs. The study seeks to determine whether intraoral splints can enhance muscle strength in patients with myogenous TMD, and which design is most effective in doing so.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with muscular TMD\n* Not using ant\n* Non pregnant women.\n* Not under convulsive, chronic pain, antidepresive, antihypertensive, pharmacological treatments\n* Without systemic pathologies.\n\nExclusion Criteria:\n\n* Treatment for chronic pain, depression, hypertension, convulsion condition with or without medication.\n* Regular use of benzodiazepines.\n* Systemic pathologies\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT07016256', 'briefTitle': 'Effect of Different Oral Splints on the Maximum Bite Force in TMD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Vina del Mar'}, 'officialTitle': 'Effect of Different Oral Splints on the Maximum Bite Force in TMD Patients', 'orgStudyIdInfo': {'id': 'UVMODO012025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lucia jig', 'description': 'Lucia jig splint', 'interventionNames': ['Device: intraoral devices']}, {'type': 'EXPERIMENTAL', 'label': 'Sved splint', 'description': 'Sved splint', 'interventionNames': ['Device: intraoral devices']}, {'type': 'EXPERIMENTAL', 'label': 'Occlusal splint', 'description': 'Occlusal splint', 'interventionNames': ['Device: intraoral devices']}], 'interventions': [{'name': 'intraoral devices', 'type': 'DEVICE', 'description': 'Intraoral devices not registed with a patent', 'armGroupLabels': ['Lucia jig', 'Occlusal splint', 'Sved splint']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2520000', 'city': 'Viña del Mar', 'state': 'Región de Valparaíso', 'country': 'Chile', 'facility': 'Universidad Viña del Mar', 'geoPoint': {'lat': -33.02457, 'lon': -71.55183}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It is not decided yet really, so we need more time to consider that'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Vina del Mar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nicolas Pinto-Pardo', 'investigatorFullName': 'Nicolás Pinto Pardo', 'investigatorAffiliation': 'Universidad Vina del Mar'}}}}