Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-02 @ 6:32 AM
Study NCT ID:
NCT05620758
Status:
UNKNOWN
Last Update Posted:
2022-12-14
First Post:
2022-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Therapy and Temporomandibular Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D053844', 'term': 'Lasers, Solid-State'}, {'id': 'D054023', 'term': 'Lasers, Semiconductor'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-11', 'studyFirstSubmitDate': '2022-11-10', 'studyFirstSubmitQcDate': '2022-11-10', 'lastUpdatePostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain', 'timeFrame': 'Baseline and 1 month', 'description': 'Visual analogue scale of pain (VAS),using a 0-10-point scale 0 score means no pain" and score 10 means "worst pain'}, {'measure': 'Chaneg in pressure pain threshold', 'timeFrame': 'Baseline and 1 month', 'description': 'The pressure pain threshold measurements for the trapezius, infraspinatus, and extensor carpi radialis muscles were performed at the center of the upper trapezius, at a position 2-3 fingers below the center of the spine of scapula, and at a position 3-4 fingers below the lateral epicondyle of the humerus, respectively. The pressure pain threshold of the extensor indicis proprius was measured by pressing toward the medial side of the radius from a position 3 fingers above the radial styloid process. The investigator placed the digital pressure algometer on a site to be inspected and pressed against the tester in a vertical direction while increasing the force at a constant rate of 1 kg/cm2. The investigator instructed the subjects to express pain either by saying "ouch" or raising their hands when only slight pain was felt. After all 8 muscles were investigated, the subjects were allowed to rest for 5 min. This procedure was repeated a total of 3 times.'}, {'measure': 'Change in Oral-health Related Quality of life (OHRQoL)', 'timeFrame': 'Baseline and 1 month', 'description': 'The OHIP-14 has 14 questions related to the evaluation of OHRQoL. The responses were recorded in a 5-point Likert scale ranging from never to very often (score is 0 to 4). Then, we calculated the total scores of all domains, and a higher score indicated poor OHRQoL. The highest possible total score of all the OHIP-14 domains is 56'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['TMD']}, 'descriptionModule': {'briefSummary': 'TMD involves a set of multiple clinical manifestations where the pain is prevalent. Treatment ideally should be noninvasive and innocuous such as photobiomodulation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pain at TMJ area.\n* Pain at masseter and temporalis muscles.\n* Age ranges between 20 and 40 years old.\n* Presence of full or nearly full complement of natural teeth\n\nExclusion Criteria:\n\n* Patients who have radiographic evidence of degenerative conditions of TMJ.\n* Patients under current dental or physical therapy that could affect TMD.\n* History of recent trauma.\n* The presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis).\n* Pregnant and lactating females'}, 'identificationModule': {'nctId': 'NCT05620758', 'briefTitle': 'Laser Therapy and Temporomandibular Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Clinical Effectiveness of a Laser Therapy in Patients With Temporomandibular Disorders (A Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': 'TMD_Laser_2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nd YAG laser', 'interventionNames': ['Other: Nd YAG laser']}, {'type': 'EXPERIMENTAL', 'label': 'Diode laser 980 nm', 'interventionNames': ['Other: diode laser (980 nm)']}, {'type': 'EXPERIMENTAL', 'label': 'Diode laser 940 nm', 'interventionNames': ['Other: diode laser (940 nm)']}, {'type': 'EXPERIMENTAL', 'label': 'Diode laser 660 nm', 'interventionNames': ['Other: diode laser (660 nm)']}, {'type': 'EXPERIMENTAL', 'label': 'Diode laser 635 nm', 'interventionNames': ['Other: diode laser (635 nm)']}], 'interventions': [{'name': 'Nd YAG laser', 'type': 'OTHER', 'description': 'patients from those diagnosed with TMD will receive Nd YAG laser 1064 nm', 'armGroupLabels': ['Nd YAG laser']}, {'name': 'diode laser (980 nm)', 'type': 'OTHER', 'description': 'patients from those diagnosed with TMD will receive a diode laser (980 nm)', 'armGroupLabels': ['Diode laser 980 nm']}, {'name': 'diode laser (940 nm)', 'type': 'OTHER', 'description': 'patients from those diagnosed with TMD will receive a diode laser (940 nm)', 'armGroupLabels': ['Diode laser 940 nm']}, {'name': 'diode laser (660 nm)', 'type': 'OTHER', 'description': 'patients from those diagnosed with TMD will receive a diode laser (660 nm)', 'armGroupLabels': ['Diode laser 660 nm']}, {'name': 'diode laser (635 nm)', 'type': 'OTHER', 'description': 'patients from those diagnosed with TMD will receive a diode laser (635 nm)', 'armGroupLabels': ['Diode laser 635 nm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Nermeen A Rady, phd', 'role': 'CONTACT', 'email': 'Abdallah.abdelaty@gmail.com'}, {'name': 'Nermeen A Rady, Phd', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mariam M Bahgat, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Alexandria Faculty of Dentistry', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Nermeen A Rady, phd', 'role': 'CONTACT', 'email': 'nermeen.rady@alexu.edu.eg', 'phone': '01223349577'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hams Hamed Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of DPH and Clinical statistician', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}