Three Photobiomodulation Wavelengths (635, 940, and 1064 nm) on Chronic Myogenic Temporomandibular Disorder
2. juni 2026 opdateret af: Alexandria University
Efficacy of Three Photobiomodulation Wavelengths (635, 940, and 1064 nm) on Chronic Myogenic Temporomandibular Disorder A Randomized Clinical Trial
Temporomandibular disorders (TMDs) are among the most common musculoskeletal conditions associated with chronic orofacial pain and functional disability.
Chronic Myogenic TMD (MTMD) is the most prevalent subtype and is characterized by persistent masticatory muscle pain driven by peripheral and central sensitization mechanisms.
Photobiomodulation (PBM) represents a conservative, non-invasive therapeutic modality within the medical management of TMD; however, the wavelength-dependent clinical and muscular effects remain inadequately defined.
Aim: To compare the efficacy of three PBM wavelengths (635, 940, 1,064 nm) on pain intensity, mandibular function, surface electromyographic activity (sEMG), and pressure pain threshold (PPT) in patients with chronic myogenic TMD.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
45
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ahmed Shafik, BDS
- Telefonnummer: 002 01275607044
- E-mail: safwat4dental@gmail.com
Studiesteder
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-
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Alexandria, Egypten
- Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
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Kontakt:
- Faculty of Dentistry
- Telefonnummer: (203) 4868308
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Ledende efterforsker:
- Ahmed Shafik, BDS
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Patients suffering from chronic myogenic TMD based on diagnostic criteria for diagnosis of temporomandibular joint disorders (DC/TMD) criteria. (pain increases with jaw opening, chewing, or clenching).
- Patients suffering of unilateral or bilateral chronic pain (> 3 months' duration) related to masseter and temporalis muscles(30).
- Patients suffering of moderate-to-severe pain intensity ≥ 4 on a 0-10 VAS
- Patients that have not responded to conservative modes of treatment during the study and up to 3 months after last intervention. (medications, physiotherapy, splints).
Exclusion Criteria:
- Patients suffering from chronic systematic conditions that alter pain sensitivity; neurological diseases, pain of dental origin, pregnancy or lactation, high blood pressure, diabetes milletus, rheumatic inflammatory disease, fibromyalgia, obstructive sleep apnea, and restrictions for the use of laser (pacemakers).
- Participants on medications that affect pain sensitivity and perception during the last 2 weeks: anticoagulants, analgesics, or antidepressants.
- History of surgery, arthropathy (joint disorders), facial trauma, malignant tumors or fractures in the orofacial region, neuropsychological or hormonal problems
- Treatments: orthodontics, splints, major occlusal rehabilitation, prosthodontic therapy, previous PBM, TENS therapy, or botox for TMD in the last 6 months.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: PBM therapy I
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Participants will receive PBM therapy using a 635 nm red diode laser (Lasotronix), standardized at a fluence of 8 J/cm² for energy density and Irradiance of 0.50 W/cm² power density in continuous wave using PBM applicator (8mm tip) for 16 seconds, near-contact working distance.
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Eksperimentel: PBM therapy II
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Participants will receive PBM therapy using a 940 nm NIR diode laser (Biolase), standardized at a fluence of 8 J/cm² and Irradiance of 0.63 W/cm² power density in continuous wave using deep tissue handpiece (10mm tip) for 12.8 seconds.
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Eksperimentel: PBM therapy III
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Participants will receive PBM therapy using a 1064 nm Nd:YAG laser (Fotona), standardized at a fluence of 8 J/cm² energy density and Irradiance 0.53 W/cm² power density, using a genova handpiece (11mm tip) stamping technique for 15.2 sec.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in subjective Pain Intensity
Tidsramme: up to 12 weeks
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It will be assessed using both visual analog scale (VAS) at baseline, 7,14,21 days, and 4, 12 weeks
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up to 12 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in maximum mouth opening
Tidsramme: up to 12 weeks
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Functional maximum mouth opening (MMO) unassisted and in the pain-free opening range (PFO) by digital caliper at baseline, 7,14,21 days, and 4, 12 weeks.
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up to 12 weeks
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Change in muscles activity
Tidsramme: up to 12 weeks
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Surface electromyography (sEMG) activity during rest and maximum voluntary clenching (MVC) activity using surface electrodes
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up to 12 weeks
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Change in Number of tender points
Tidsramme: up to 12 weeks
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by palpation pressure of muscles
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up to 12 weeks
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Change in pressure pain threshold
Tidsramme: up to 12 weeks
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Pressure pain threshold (PPT) over the most tender point of the masseter and temporalis muscles by a pressure algometer (PA) to measure the degree of tenderness over the most tender points at the muscles
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up to 12 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
30. december 2026
Studieafslutning (Anslået)
30. december 2026
Datoer for studieregistrering
Først indsendt
28. maj 2026
Først indsendt, der opfyldte QC-kriterier
2. juni 2026
Først opslået (Faktiske)
4. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. juni 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1320 - 04 / 2026
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