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970-nm Diode Laser Versus Liquid Nitrogen Cryotherapy in Maxillary Labial Frenectomy (MLF-DL-KRYO)

2026年7月13日 更新者：Kutahya Health Sciences University

Comparison of Salivary Cortisol Response and Early Postoperative Outcomes Following 970-nm Diode Laser and Liquid Nitrogen Cryotherapy in Maxillary Labial Frenectomy: A Randomized Single-Blind Clinical Trial

This prospective, randomized, single-blind, assessor-blinded, parallel-group clinical trial aims to compare the effects of 970-nm diode laser and liquid nitrogen cryotherapy in patients requiring maxillary labial frenectomy.

The primary objective is to compare the change in salivary cortisol levels from baseline to postoperative day 2 between the two treatment groups. Secondary objectives include comparison of postoperative pain, edema, interincisal mouth opening, analgesic consumption, operation duration, state anxiety, clinical wound healing, and adverse events.

Eligible adult patients with an indication for maxillary labial frenectomy will be randomly assigned to receive either 970-nm diode laser frenectomy or liquid nitrogen cryotherapy. Salivary cortisol samples and clinical outcomes will be assessed during the early postoperative follow-up period.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

Maxillary labial frenulum abnormalities may be associated with diastema, plaque accumulation, periodontal irritation, gingival recession, oral hygiene difficulty, functional discomfort, and esthetic concerns. Frenectomy may be indicated when the frenulum is hypertrophic, short, thick, or inserted close to the interdental papilla.

Conventional scalpel frenectomy is effective but may be associated with intraoperative bleeding, need for suturing, postoperative pain, edema, and reduced patient comfort. Minimally invasive approaches such as diode laser surgery and cryotherapy may offer potential advantages in oral soft tissue procedures.

This study will compare two minimally invasive approaches for maxillary labial frenectomy: 970-nm diode laser and liquid nitrogen cryotherapy. Participants will be randomized into two parallel groups. In the diode laser group, frenectomy will be performed using a 970-nm diode laser at 2 W in continuous wave mode with a 320-micrometer sterile fiber tip using a contact technique. In the liquid nitrogen cryotherapy group, open-spray cryotherapy will be applied to the maxillary labial frenulum region with two freeze-thaw cycles.

The primary endpoint is the change in salivary cortisol level from baseline to postoperative day 2. Secondary endpoints include postoperative day 7 salivary cortisol change, postoperative pain measured by visual analog scale, edema, interincisal mouth opening, total analgesic consumption, operation duration, State-Trait Anxiety Inventory-State score, Landry, Turnbull and Howley wound healing index scores, and postoperative complications or adverse events.

All procedures and salivary sampling will be standardized and performed in the morning to reduce the influence of circadian variation on cortisol measurements. The study will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Kutahya Health Sciences University.

研究の種類

介入

入学 (推定)

40

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • トルコ（Türkiye）
    • Kütahya
      • Kütahya、Kütahya、トルコ（Türkiye）、43020
        • Kütahya Health Sciences University Faculty of Dentistry
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Muhammet Yasin Pektaş, Asst. Prof., DDS

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Age between 18 and 65 years.
  • Systemically healthy, ASA I status.
  • Clinical indication for maxillary labial frenectomy.
  • Ability to attend postoperative follow-up visits.
  • Provision of written informed consent.

Exclusion Criteria:

  • Systemic or local corticosteroid use within the last 6 months.
  • Endocrine disease that may affect cortisol levels.
  • Pregnancy or lactation.
  • Active oral infection.
  • Chronic analgesic or anti-inflammatory drug use.
  • Psychiatric medication use.
  • Smoking.
  • ASA II or higher systemic status.
  • Inability to attend follow-up visits.
  • Refusal to participate in the study.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：970-nm Diode Laser Frenectomy
Participants randomized to this arm will undergo maxillary labial frenectomy using a 970-nm diode laser. The procedure will be performed with a SiroLaser Advance device at 970 nm wavelength, 2 W power, continuous wave mode, and a 320-micrometer sterile fiber tip using a contact technique. The total laser application time will be standardized as 2 minutes. The surgical area will not be sutured and will be left to heal by secondary intention.
手順：970-nm Diode Laser Frenectomy
Maxillary labial frenectomy will be performed using a 970-nm diode laser device at 2 W power in continuous wave mode with a 320-micrometer sterile fiber tip using a contact technique. The total laser application time will be standardized as 2 minutes. The surgical area will not be sutured and will be left to heal by secondary intention.
他の名前：
  • Diode laser frenectomy
実験的：Liquid Nitrogen Cryotherapy
Participants randomized to this arm will receive liquid nitrogen cryotherapy applied to the maxillary labial frenulum region using an open-spray technique. Two freeze-thaw cycles will be performed; each freezing cycle will last 15 seconds, with passive complete thawing between cycles. No mechanical excision will be performed after cryotherapy. The target tissue is expected to be eliminated through cryogenic necrosis and secondary healing. The surgical area will not be sutured.
手順：Liquid Nitrogen Cryotherapy
Liquid nitrogen cryotherapy will be applied to the maxillary labial frenulum region using an open-spray technique. Two freeze-thaw cycles will be performed; each freezing cycle will last 15 seconds, with passive complete thawing between cycles. No mechanical excision will be performed after cryotherapy, and the surgical area will not be sutured.

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
Change in salivary cortisol level from baseline to postoperative day 2
時間枠：Baseline and postoperative day 2
Salivary cortisol will be measured in unstimulated saliva samples using an ELISA method. For each participant, the change in salivary cortisol level from the preoperative baseline measurement to postoperative day 2 will be calculated and compared between the two intervention groups. Results will be recorded in nmol/L.
Baseline and postoperative day 2

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in salivary cortisol level from baseline to postoperative day 7
時間枠：Baseline and postoperative day 7
Salivary cortisol will be measured in unstimulated saliva samples using an ELISA method. For each participant, the change in salivary cortisol level from the preoperative baseline measurement to postoperative day 7 will be calculated and compared between the two intervention groups. Results will be recorded in nmol/L.
Baseline and postoperative day 7
Change in postoperative edema
時間枠：Baseline, postoperative day 2, and postoperative day 7
Postoperative edema will be assessed using standardized facial measurements. Changes in edema measurements from baseline to postoperative day 2 and postoperative day 7 will be calculated and compared between the two intervention groups.
Baseline, postoperative day 2, and postoperative day 7
Postoperative pain intensity
時間枠：Postoperative 6 hours, 12 hours, 24 hours, day 2, and day 7
Postoperative pain intensity will be assessed using a 0-to-10 visual analog scale, where higher scores indicate greater pain intensity.
Postoperative 6 hours, 12 hours, 24 hours, day 2, and day 7
Change in interincisal mouth opening
時間枠：Baseline, postoperative day 2, and postoperative day 7
Interincisal mouth opening will be measured in millimeters. Changes from baseline to postoperative day 2 and postoperative day 7 will be calculated and compared between the two intervention groups.
Baseline, postoperative day 2, and postoperative day 7
Total analgesic consumption during the first postoperative week
時間枠：Postoperative days 0 to 7
Analgesic consumption will be recorded as the total number of analgesic tablets used by each participant during the first postoperative week.
Postoperative days 0 to 7
Operation duration
時間枠：During the intervention procedure
Operation duration will be recorded in minutes for each participant and compared between the two intervention groups.
During the intervention procedure
State anxiety score
時間枠：Baseline, postoperative day 2, and postoperative day 7
State anxiety will be assessed using the State-Trait Anxiety Inventory-State form. Total scores will be recorded preoperatively and on postoperative days 2 and 7, and compared between the two intervention groups.
Baseline, postoperative day 2, and postoperative day 7
Clinical wound healing score
時間枠：Postoperative days 2, 7, 14, and 21
Clinical wound healing will be assessed using the Landry, Turnbull and Howley Wound Healing Index. Wound healing scores will be recorded on postoperative days 2, 7, 14, and 21 and compared between the two intervention groups.
Postoperative days 2, 7, 14, and 21
Postoperative complications and adverse events
時間枠：From the intervention procedure through postoperative day 21
The occurrence of postoperative complications or adverse events, including unexpected pain, bleeding, infection, wound healing problems, or other procedure-related adverse events, will be recorded during the follow-up period.
From the intervention procedure through postoperative day 21

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Kutahya Health Sciences University

捜査官

  • 主任研究者：Muhammet Yasin Pektaş, Asst. Prof, DDS、Kutahya Health Sciences University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月30日

一次修了 (推定)

2027年5月2日

研究の完了 (推定)

2027年5月21日

試験登録日

最初に提出

2026年7月13日

QC基準を満たした最初の提出物

2026年7月13日

最初の投稿 (実際)

2026年7月16日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月16日

QC基準を満たした最後の更新が送信されました

2026年7月13日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • MLF-DL-KRYO-2026-01

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?

いいえ

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

いいえ

米国FDA規制機器製品の研究

いいえ

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