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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Ankara
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Ankara、Ankara、トルコ（Türkiye）
- Ankara University Faculty of Dentistry
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Sunnybrook Facial Grading System Score
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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House-Brackmann Grading System
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Mehmet Emre Yurttutan, DDS, PhD、Ankara University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- AU-TMJ-PBM-2022
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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