[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595365":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":31,"collaborators":26,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":26,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":26,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":26,"overallStatus":55,"whyStopped":26,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":26},{"fullName":5,"class":6},"University of Nove de Julho","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 - Local photobiomodulation","EXPERIMENTAL","Participants in this arm will receive local photobiomodulation using a high-power superpulsed diode laser (GeminiEvo, Ultradent, USA) with dual wavelengths (810 nm and 980 nm). The protocol consists of 8 sessions (twice weekly for 4 weeks), with laser applied to the masseter, temporal, trapezius, and temporomandibular joint (TMJ) regions. Each point will be irradiated for 13 seconds using 4 J of energy (10.52 J\u002Fcm²) with a contact technique. Safety procedures include use of protective eyewear and disinfection of the device tip.",[13],"Device: Active Photobiomodulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 2 - Sham local photobiomodulation","SHAM_COMPARATOR","Participants in this arm will undergo the same treatment protocol as the experimental group. However, the device will be deactivated (no laser emission), while maintaining the guide light and operational sounds to ensure participant blinding. All application parameters and session conditions will mimic the active group.",[19],"Device: Sham Photobiomodulation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Active Photobiomodulation","Local photobiomodulation using a high-power superpulsed diode laser (GeminiEvo, Ultradent, USA) with dual infrared wavelengths (810 nm and 980 nm). Eight sessions will be conducted (twice a week for 4 weeks). Application will be at one point each on the masseter, temporal, trapezius, and temporomandibular joint regions. Each point will be irradiated for 13 seconds with 4 J of energy (10.52 J\u002Fcm²), in contact mode. The procedure includes safety measures such as protective eyewear and disinfection of the laser tip.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham Photobiomodulation","The same application protocol as the experimental group will be followed, using the same laser device (GeminiEvo, Ultradent, USA), but with the laser emission deactivated. The guide light and sound will remain active to preserve participant blinding. Application points, duration, frequency, and session environment will be identical to the active group.",[15],{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Sandra Kalil Bussadori","Principal Investigator","100595365","effects-of-photobiomodulation-with-superpulsed-laser-and-dual-wavelengths-in-children-and-adolescents-100595365",false,"NCT07031505","Effects of Photobiomodulation With Superpulsed Laser and Dual Wavelengths in Children and Adolescents","Effects of Photobiomodulation With Superpulsed Laser and Dual Wavelength (810 + 980 NM) in Children and Adolescents With Facial Muscle Pain and Headache: Protocol for a Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Children and adolescents 6 to 17 years of age enrolled at the medical and dental clinic of Universidade Nove de Julho (UNINOVE), Vergueiro Campus;\n* Children and adolescents who present with at least one symptom of orofacial pain and\u002For headache, according to the Faces Pain Scale and the childhood and adolescence headache questionnaire based on the ICHD-3\n\nExclusion Criteria:\n\n* Pregnant adolescents;\n* Having taken corticoids, non-steroidal anti-inflammatory drugs or analgesics in the previous 30 days;\n* Having taken isotretinoin;\n* Individuals who report photosensitivity to laser or LED in previous treatments.","ALL","6 Years","17 Years",{"count":46,"type":47},60,"ESTIMATED","INTERVENTIONAL",[50],"NA","This randomized clinical trial evaluates the effects of photobiomodulation with a superpulsed diode laser (810 + 980 nm) on orofacial pain and tension-type headache in children and adolescents. Sixty participants will be assigned to receive active PBM or sham therapy over eight sessions. Pain and anthropometric variables will be assessed.",[53,54],"Facial Pain","Headache","NOT_YET_RECRUITING","2025-06-12",{"date":58,"type":59},"2025-06-22","ACTUAL",{"date":61,"type":47},"2025-07-01",{"date":63,"type":47},"2026-04-30",{"name":5,"class":6}]