[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628381":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":30,"responsibleParty":53,"collaborators":30,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":30,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":30,"enrollmentInfo":65,"targetDuration":30,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":77,"overallStatus":80,"whyStopped":30,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":86,"leadSponsor":88,"locationsCount":30},{"fullName":5,"class":6},"Federal University of Rio Grande do Sul","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Photobiomodulation Therapy","EXPERIMENTAL","Participants assigned to this arm will receive photobiomodulation therapy using a dual-wavelength diode laser (810 + 980 nm) applied extraorally over standardized anatomical points corresponding to the temporomandibular joint and masticatory muscles. The intervention consists of 12 treatment sessions conducted over four weeks.",[13],"Device: Photobiomodulation Therapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Photobiomodulation Therapy + Exercises","Participants assigned to this arm will receive extraoral photobiomodulation therapy (PBM) using a Gemini EVO dual-wavelength diode laser (810 + 980 nm), delivering 20 J per application point over standardized anatomical points of the temporomandibular joint and masticatory muscles (six points per side). The intervention consists of 12 treatment sessions conducted over four weeks.\n\nAdditionally, participants will perform a standardized home-based therapeutic exercise program once daily, including self-massage of the masseter and temporal muscles, cheek inflation exercises, and controlled mandibular opening and closing movements with tongue positioning on the palate. Written and in-person instructions, a demonstration video, daily reminders, and adherence monitoring through exercise logs will be provided.",[13,18],"Behavioral: Therapeutic Exercises",{"label":20,"type":21,"description":22,"interventionNames":23},"Sham Photobiomodulation Therapy + Exercises","SHAM_COMPARATOR","Participants assigned to this arm will receive sham extraoral photobiomodulation therapy using a Gemini EVO dual-wavelength diode laser (810 + 980 nm), applied over standardized anatomical points of the temporomandibular joint and masticatory muscles with identical procedures to the active protocol, but without therapeutic energy emission to maintain participant blinding. The simulated intervention consists of 12 sessions conducted over four weeks.\n\nAdditionally, participants will perform the same standardized home-based therapeutic exercise program once daily, including self-massage of the masseter and temporal muscles, cheek inflation exercises, and controlled mandibular opening and closing movements with tongue positioning on the palate. Written and in-person instructions, a demonstration video, daily reminders, and adherence monitoring through exercise logs will be provided.",[18,24],"Device: Sham Photobiomodulation Therapy",[26,31,36],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","Photobiomodulation therapy (PBM) will be delivered using a dual-wavelength diode laser device (810 + 980 nm) applied extraorally over standardized anatomical points corresponding to the temporomandibular joint and masticatory muscles. The intervention is performed using a non-thermal protocol, delivering 20 J per application point. Irradiation is applied bilaterally at predefined sites, including the masseter muscle, temporomandibular joint region, and temporal muscle. The procedure is performed by trained operators according to a standardized protocol to ensure consistency across sessions. This device-based intervention aims to modulate pain, improve microcirculation, and promote functional recovery in individuals with myofascial temporomandibular disorders.",[9,15],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"BEHAVIORAL","Therapeutic Exercises","A standardized home-based therapeutic exercise program will be performed once daily throughout the intervention period. The protocol includes self-massage of the masseter and temporal muscles using circular fingertip movements with light to moderate pressure, cheek inflation exercises alternating sides, and controlled mandibular opening and closing movements with the tongue positioned against the palate. Written instructions and in-person guidance will be provided, along with a demonstration video to support correct execution. Participants will receive daily reminder messages, and adherence will be monitored through individual exercise logs completed throughout the study.",[15,20],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":30},"Sham Photobiomodulation Therapy","Sham photobiomodulation therapy will be delivered using a Gemini EVO dual-wavelength diode laser device (810 + 980 nm) positioned and operated identically to the active PBM protocol. The device will be applied extraorally over standardized anatomical points corresponding to the temporomandibular joint and masticatory muscles; however, no therapeutic energy will be emitted, ensuring a placebo condition while maintaining participant blinding. The simulated intervention will follow the same number of sessions, duration, and procedures as the active PBM protocol.",[20],[41],{"name":42,"affiliation":5,"role":43},"Manoela Domingues Martins, DDS, MSc, PhD","PRINCIPAL_INVESTIGATOR",[45,49],{"name":42,"role":46,"phone":47,"phoneExt":30,"email":48},"CONTACT","5551 99608802","manomartins@gmail.com",{"name":50,"role":46,"phone":51,"phoneExt":30,"email":52},"Júlia Breda Soares, DDS, MSc","5554 96077474","julia.breda.soares@gmail.com",{"type":43,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Manoela Domingues Martins","Associate Professor","100628381","effectiveness-of-photobiomodulation-for-myofascial-pain-in-temporomandibular-disorders-100628381",false,"NCT07460895","Effectiveness of Photobiomodulation for Myofascial Pain in Temporomandibular Disorders","Photobiomodulation in the Management of Myofascial Pain: A Randomized and Blinded Clinical Trial","Inclusion Criteria:\n\n* Individuals with myofascial TMD (ICD-9 729.1; ICD-10 M79.1) diagnosed according to the DC\u002FTMD criteria;\n* Participants aged 18 years or older;\n* Individuals able to communicate, read, write, and provide written informed consent in Portuguese.\n\nExclusion Criteria:\n\n* Patients with a history of autoimmune connective tissue diseases, such as rheumatoid arthritis, psoriatic arthritis, scleroderma, or systemic lupus erythematosus;\n* History of malignancy in the head and neck region within the past 2 years (except basal cell carcinoma) who have undergone head and neck radiation therapy and\u002For surgery affecting facial muscles;\n* Patients who have undergone temporomandibular joint surgery or orthognathic surgery;\n* Pregnant or breastfeeding women;\n* Patients with poorly adapted prostheses and\u002For prostheses associated with inadequate increase or decrease of the vertical dimension;\n* Patients with a history of tardive dyskinesia or oromandibular\u002Fcervical dystonia; -Patients with maximum mouth opening less than 35 mm;\n* Patients using systemic medications with a potential effect on pain at the time of screening will not be included in the study, including analgesics, anti-inflammatory drugs, muscle relaxants, corticosteroids, or other medications with analgesic and\u002For anti-inflammatory effects.\n\nIf a participant initiates the use of any such medication during the follow-up period, the participant will be excluded from the study.\n\n\\- Patients receiving oral and\u002For intravenous corticosteroid bolus therapy at doses \\> 1 mg\u002Fkg within the past 3 months, and those receiving biologic agents within 1 month or five times the drug half-life, whichever is longer; Individuals with mental or psychological conditions that may prevent participation in the study.","ALL","18 Years",{"count":66,"type":67},140,"ESTIMATED","INTERVENTIONAL",[70],"NA","This randomized clinical trial aims to evaluate the effectiveness of photobiomodulation therapy (PBM) alone or combined with therapeutic exercises compared with placebo PBM associated with exercises in patients with myofascial temporomandibular disorders (TMD). Participants will be allocated into three groups: PBM alone, PBM combined with exercises, or placebo PBM combined with exercises. The intervention consists of 12 treatment sessions. Outcomes related to pain intensity, mandibular function, and clinical measures will be assessed over time. The study seeks to investigate whether PBM provides additional benefits in pain reduction and functional improvement in individuals with myofascial TMD.",[73,74,75,76],"Photobiomodulation","Temporomandibular Disorder (TMD)","Myofacial Pain","Pain Management",[73,78,79,76],"Myofascial Pain","Temporomandibular Disorder","NOT_YET_RECRUITING","2026-03-05",{"date":83,"type":84},"2026-03-10","ACTUAL",{"date":83,"type":67},{"date":87,"type":67},"2030-12",{"name":5,"class":6}]