Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-26 @ 1:51 PM
Study NCT ID:
NCT06068959
Status:
UNKNOWN
Last Update Posted:
2024-01-03
First Post:
2023-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photobiomodulation on Pain in Patients With Temporomandibular Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-08-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-02', 'studyFirstSubmitDate': '2023-09-28', 'studyFirstSubmitQcDate': '2023-10-04', 'lastUpdatePostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Baseline', 'timeFrame': 'Before an intervention', 'description': 'Evaluation of Pain using visual analogic scale in centimeters (0-10cm)'}, {'measure': 'Final Pain', 'timeFrame': '2 weeks after treatment', 'description': 'Evaluation of Pain using visual analogic scale in centimeters (0-10cm)'}], 'secondaryOutcomes': [{'measure': 'Cervical spine mobility baseline', 'timeFrame': 'Before an intervention', 'description': 'Evaluation of cervical spine mobility using goniometer in degrees'}, {'measure': 'Final Cervical spine mobility', 'timeFrame': '2 weeks after intervention', 'description': 'Evaluation of cervical spine mobility using goniometer in degrees'}, {'measure': 'Mandibular mobility baseline', 'timeFrame': 'Before an intervention', 'description': 'Evaluation of mandibular mobility using caliper in millimeters'}, {'measure': 'Final Mandibular mobility', 'timeFrame': '2 weeks after intervention', 'description': 'Evaluation of mandibular mobility using caliper in millimeters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['TMJ Pain']}, 'descriptionModule': {'briefSummary': 'These studies aim to validate the effects of photobiomodulation using clusters of 850nm LEDs (infrared) and 630nm LEDs (red); in pain and cervical and mandibular mobility in patients with TMD. It is a randomized, controlled, and blind clinical trial, which will consist of n= 36, of both genders, with ages ranging from 18 to 45 years, divided into 2 groups: Group 1 Red and infrared LED cluster, Group 2 placebo. The areas where they will receive photobiomodulation will be the TMJ area, masseter muscles, temporal muscles, scalenes, and trapezius. 6 non-consecutive sessions will be performed over 2 weeks. Diagnostic Criteria for Temporomandibular Disorders - DC/TMD will be used to determine TMD and validate participants. To validate the mandibular range of motion (ADM) a pachymeter will be used and for the cervical ADM a goniometer (fleximeter). The pain will be validated using the visual analog scale-VAS. All participants will be evaluated after the first therapeutic intervention, and again at the end, following the same validation procedures used initially.', 'detailedDescription': 'The term temporomandibular disorders (TMD), according to the American American Dental Association (ADA), refers to a group of disorders characterized by pain in the temporomandibular joint (TMD) in the periauricular area or in the masticatory muscles, in addition to TMD sounds during jaw function and deviation or restriction of jaw movements. Its multifactorial etiology is related to a heterogeneous group of functional, structural, and psychological factors, making it difficult to identify the association between a single etiological factor and the signs and symptoms of TMD. As a treatment option, it hasphotobiomodulation, using different light sources, alone or in combination. These studies aim to validate the effects of photobiomodulation using clusters of 850nm LEDs (infrared) and 630nm LEDs (red); in pain and cervical and mandibular mobility in patients with TMD. It is a randomized, controlled, and blind clinical trial, which will consist of n= 36, of both genders, with ages ranging from 18 to 45 years, divided into 2 groups: Group 1 Red and infrared LED cluster, Group 2 placebo. The areas where they will receive photobiomodulation will be the TMJ area, masseter muscles, temporal muscles, scalenes, and trapezius. 6 non-consecutive sessions will be performed over 2 weeks. Diagnostic Criteria for Temporomandibular Disorders - DC/TMD will be used to determine TMD and validate participants. To validate the mandibular range of motion (ADM) a pachymeter will be used and for the cervical ADM a goniometer (fleximeter). The pain will be validated using the visual analog scale-VAS. All participants will be evaluated after the first therapeutic intervention, and again at the end, following the same validation procedures used initially.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* present TMD according Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I\n* have all permanent teeth\n\nExclusion Criteria:\n\n* be undergoing orthodontic treatment\n* be undergoing other treatment for TMD\n* present dental caries or gingival disease.\n* Initiate or use any type of medication during the phases of the study\n* comorbidity'}, 'identificationModule': {'nctId': 'NCT06068959', 'briefTitle': 'Photobiomodulation on Pain in Patients With Temporomandibular Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'University of Nove de Julho'}, 'officialTitle': 'Effect of Photobiomodulation With LED Cluster on Pain and Mandibular and Cervical Mobility in Patients With Temporomandibular Dysfunction: Clinical, Randomized, Controlled and Blind Study', 'orgStudyIdInfo': {'id': '220824a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Photobiomodulation', 'description': 'Photobiomodulation using a LED cluster', 'interventionNames': ['Device: Photobiomodulation using LED']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Photobiomodulation', 'description': 'Placebo Photobiomodulation with the equipment turned off', 'interventionNames': ['Device: Placebo']}], 'interventions': [{'name': 'Photobiomodulation using LED', 'type': 'DEVICE', 'description': 'Photobiomodulation Using a Cluster of LEDs in the Red and Infrared Wavelengths in the Cervical Spine Region and Over the Masticatory Muscles', 'armGroupLabels': ['Photobiomodulation']}, {'name': 'Placebo', 'type': 'DEVICE', 'description': 'Photobiomodulation Placebo', 'armGroupLabels': ['Placebo Photobiomodulation']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nove de Julho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Anna Carolina Ratto Tempestini Horliana', 'investigatorAffiliation': 'University of Nove de Julho'}}}}