Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-01-01 @ 9:41 AM
Study NCT ID:
NCT06327204
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2024-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Different Low Level Laser Therapy Sessions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2024-03-15', 'studyFirstSubmitQcDate': '2024-03-20', 'lastUpdatePostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain score', 'timeFrame': '8 weeks', 'description': 'a 10-point visual analogue score'}], 'secondaryOutcomes': [{'measure': 'maximum mouth opening', 'timeFrame': '8 weeks', 'description': 'measuring the interincisal distance between the upper and lower central incisors'}, {'measure': 'quality of life questioner', 'timeFrame': '8 weeks', 'description': 'Oral Health Impact Profile questionnaire (OHIP-14) containing 14 questions divided into seven domains of oral health'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trigger Point Pain, Myofascial, Laser therapy'], 'conditions': ['Myofascial Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '23318917', 'type': 'BACKGROUND', 'citation': 'Ahrari F, Madani AS, Ghafouri ZS, Tuner J. The efficacy of low-level laser therapy for the treatment of myogenous temporomandibular joint disorder. Lasers Med Sci. 2014 Mar;29(2):551-7. doi: 10.1007/s10103-012-1253-6. Epub 2013 Jan 15.'}, {'pmid': '23329239', 'type': 'BACKGROUND', 'citation': 'Maia ML, Bonjardim LR, Quintans Jde S, Ribeiro MA, Maia LG, Conti PC. Effect of low-level laser therapy on pain levels in patients with temporomandibular disorders: a systematic review. J Appl Oral Sci. 2012 Nov-Dec;20(6):594-602. doi: 10.1590/s1678-77572012000600002.'}, {'pmid': '39327563', 'type': 'DERIVED', 'citation': 'Mahmoud NR, Shehab WI, AlAraby AA, Habaka YF. Efficacy of different low-level laser therapy sessions in the management of masseter muscle trigger points. BMC Oral Health. 2024 Sep 26;24(1):1125. doi: 10.1186/s12903-024-04780-y.'}]}, 'descriptionModule': {'briefSummary': 'Myofascial pain dysfunction syndrome is one of the common causes of non-odontogenic pain in the head and neck region. It accounts for 40-60% of the adult population. Different treatment modalities had been reported to release the trigger point within the muscles of mastication in order to reduce pain and allow recovery of the function.', 'detailedDescription': "Low-level laser therapy has been a research focus in past few years as it provides effective and conservative treatment modality with minimal patient discomfort. LLLT promotes the release of endogenous opioids, enhance tissue repair and cellular respiration, increase vasodilatation and pain relief Recent systematic review and meta-analysis had reported that the available evidence didn't allow clinicians to draw firm conclusions on effective dosage. This study aimed to investigate the effect of different LLLT sessions' number on pain, maximum mouth opening and quality of life in patients with masseter muscle trigger points."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. definite diagnosis of myofascial pain based on the DC/TMD criteria with a referral\n2. presence of one or more trigger points in the masseter muscle\n3. no history of any invasive procedures of the related masseter muscle.\n\nExclusion Criteria:\n\n1. any painful conditions affecting the orofacial region\n2. any systemic diseases that could masticatory function (e.g., rheumatoid arthritis and epilepsy)\n3. pregnancy and lactation.'}, 'identificationModule': {'nctId': 'NCT06327204', 'briefTitle': 'Efficacy of Different Low Level Laser Therapy Sessions', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Efficacy of Different Low Level Laser Therapy Sessions in Management of Masseter Muscle Trigger Points', 'orgStudyIdInfo': {'id': 'Low Level laser 24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I', 'description': 'patient received one session / week', 'interventionNames': ['Device: 940-nm diode laser / one session']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group II', 'description': 'patient received two session / week', 'interventionNames': ['Device: 940-nm diode laser / two session']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group III', 'description': 'Patient received three session / week', 'interventionNames': ['Device: 940-nm diode laser/ three session']}], 'interventions': [{'name': '940-nm diode laser / one session', 'type': 'DEVICE', 'description': 'laser therapy using a 940-nm diode laser / one session per week', 'armGroupLabels': ['Group I']}, {'name': '940-nm diode laser / two session', 'type': 'DEVICE', 'description': 'laser therapy using a 940-nm diode laser / two session per week', 'armGroupLabels': ['group II']}, {'name': '940-nm diode laser/ three session', 'type': 'DEVICE', 'description': 'laser therapy using a 940-nm diode laser / three session per week', 'armGroupLabels': ['Group III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21523', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, October 6 University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'amany Ahmed, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of dentistry, October 6 University, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of Oral Medicine', 'investigatorFullName': 'Amany Ahmed AlAraby', 'investigatorAffiliation': 'October 6 University'}}}}