Comparison of Two Photobiomodulation Systems for Facial Nerve Dysfunction Following TMJ Surgery
Comparison of the Clinical Effectiveness of Two Photobiomodulation Systems for Facial Nerve Dysfunction Following Temporomandibular Joint Surgery
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
This prospective, randomized, parallel-group clinical trial was conducted in patients who developed postoperative facial nerve dysfunction following open temporomandibular joint surgery. Eligible participants were randomly allocated in a 1:1 ratio to one of two active photobiomodulation treatment groups using a computer-generated block randomization sequence.
Participants assigned to the GRR Laser group received extraoral transcutaneous photobiomodulation using a dual-wavelength 650-nm and 904-nm laser/LED system. Participants assigned to the SiroLaser Advance Plus group received extraoral transcutaneous photobiomodulation using a 660-nm continuous-wave diode laser. In both groups, irradiation was applied along the anatomical projection of the clinically affected facial nerve branches on the operated side.
Photobiomodulation treatment was initiated on the first postoperative day. Treatment was administered daily during the first five postoperative days and every other day thereafter, for a total of 15 treatment sessions. Each treatment session lasted approximately 10 minutes.
Facial nerve function was evaluated on postoperative days 5, 7, 10, 30, and 60. Clinical assessments included the House-Brackmann Grading System and the Sunnybrook Facial Grading System. Patient-reported functional status and quality of life were assessed using the Facial Clinimetric Evaluation (FaCE) Scale. The first standardized outcome assessment was performed on postoperative day 5; therefore, this assessment represented the first standardized postoperative evaluation rather than a pretreatment baseline.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Ankara
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Ankara, Ankara, Turkije (Türkiye)
- Ankara University Faculty of Dentistry
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Patients who underwent open temporomandibular joint surgery.
- Presence of clinically confirmed postoperative facial nerve dysfunction.
- Willingness to comply with the follow-up protocol and attend scheduled follow-up visits.
- Provision of written informed consent.
Exclusion Criteria:
- Pre-existing facial nerve paralysis or facial nerve dysfunction before surgery.
- History of central neurological disease.
- Previous surgery involving the facial nerve.
- History of head and neck malignancy and/or chemotherapy or radiotherapy that could potentially affect facial nerve function.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: SiroLaser Advance Plus Group
Participants received photobiomodulation using the SiroLaser Advance Plus system.
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Extraoral transcutaneous photobiomodulation was delivered using the SiroLaser Advance Plus system in SoftLase mode.
Irradiation was provided using a 660-nm continuous-wave diode laser with an output power of 25 mW through an 8-mm fiber-optic tip.
Treatment was applied along the anatomical projection of the clinically affected facial nerve branches.
Treatment began on the first postoperative day and consisted of 15 sessions using the same treatment schedule as the GRR Laser group.
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Experimenteel: GRR Laser Group
Participants received photobiomodulation using the GRR Laser system.
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Extraoral transcutaneous photobiomodulation was delivered using the GRR Laser system, a dual-wavelength 650-nm and 904-nm laser/LED system.
Treatment was applied along the anatomical projection of the clinically affected facial nerve branches.
Treatment began on the first postoperative day and consisted of 15 sessions, administered daily during the first 5 postoperative days and every other day thereafter.
Each session lasted approximately 10 minutes.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Sunnybrook Facial Grading System Score
Tijdsspanne: From postoperative day 5 to postoperative day 60
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The Sunnybrook Facial Grading System was used to assess facial nerve function based on resting symmetry, voluntary facial movement, and synkinesis.
The composite score ranges from 0 to 100, with higher scores indicating better facial nerve function.
The change score was calculated as the postoperative day 60 score minus the postoperative day 5 score.
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From postoperative day 5 to postoperative day 60
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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House-Brackmann Grading System
Tijdsspanne: Postoperative days 5, 7, 10, 30, and 60
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Facial nerve function was graded using the House-Brackmann Grading System, which classifies facial nerve function from Grade I (normal function) to Grade VI (complete paralysis), with higher grades indicating greater dysfunction.
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Postoperative days 5, 7, 10, 30, and 60
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Facial Clinimetric Evaluation (FaCE) Scale
Tijdsspanne: Postoperative days 5, 7, 10, 30, and 60
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The FaCE Scale is a 15-item patient-reported measure assessing facial movement, facial comfort, oral function, eye comfort, lacrimal control, and social function.
Total scores are transformed to a 0-100 scale, with higher scores indicating better facial function and quality of life.
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Postoperative days 5, 7, 10, 30, and 60
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Mehmet Emre Yurttutan, DDS, PhD, Ankara University
Studie record data
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Studie voltooiing (Werkelijk)
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- AU-TMJ-PBM-2022
Plan Individuele Deelnemersgegevens (IPD)
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