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Comparison of Two Photobiomodulation Systems for Facial Nerve Dysfunction Following TMJ Surgery

17 augusti 2026 uppdaterad av: Mehmet Emre Yurttutan, Ankara University

Comparison of the Clinical Effectiveness of Two Photobiomodulation Systems for Facial Nerve Dysfunction Following Temporomandibular Joint Surgery

This randomized clinical trial compared two photobiomodulation systems for the management of postoperative facial nerve dysfunction following temporomandibular joint surgery. Patients who developed clinically detectable facial nerve dysfunction after open temporomandibular joint surgery were randomly assigned to receive photobiomodulation using either the GRR Laser system or the SiroLaser Advance Plus system. Photobiomodulation was initiated on the first postoperative day and consisted of 15 treatment sessions. Facial nerve recovery was evaluated using the House-Brackmann Grading System, the Sunnybrook Facial Grading System, and the Facial Clinimetric Evaluation (FaCE) Scale during a 60-day follow-up period.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

24

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Turkiet (Türkiye)
    • Ankara
      • Ankara, Ankara, Turkiet (Türkiye)
        • Ankara University Faculty of Dentistry

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: SiroLaser Advance Plus Group
Participants received photobiomodulation using the SiroLaser Advance Plus system.
Enhet: SiroLaser Advance Plus
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.
Experimentell: GRR Laser Group
Participants received photobiomodulation using the GRR Laser system.
Enhet: GRR Laser Photobiomodulation System
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Sunnybrook Facial Grading System Score
Tidsram: From postoperative day 5 to postoperative day 60
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.
From postoperative day 5 to postoperative day 60

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
House-Brackmann Grading System
Tidsram: Postoperative days 5, 7, 10, 30, and 60
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.
Postoperative days 5, 7, 10, 30, and 60
Facial Clinimetric Evaluation (FaCE) Scale
Tidsram: Postoperative days 5, 7, 10, 30, and 60
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.
Postoperative days 5, 7, 10, 30, and 60

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Ankara University

Utredare

  • Huvudutredare: Mehmet Emre Yurttutan, DDS, PhD, Ankara University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

12 maj 2022

Primärt slutförande (Faktisk)

22 juni 2026

Avslutad studie (Faktisk)

22 juni 2026

Studieregistreringsdatum

Först inskickad

13 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

17 augusti 2026

Första postat (Faktisk)

19 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • AU-TMJ-PBM-2022

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Individual participant data will not be shared because no prospective data-sharing plan was established for this study.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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