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Healing Efficacy of Diode Laser in Lingual Frenectomy

2026年4月22日 更新者：Phong Dai Lam、University of Medicine and Pharmacy at Ho Chi Minh City

Evaluation of the Healing Efficacy of Diode Laser in Lingual Frenectomy

This study aims to compare the wound healing efficacy and postoperative experiences between the 940 nm diode laser technique and the traditional electrosurgery method for treating ankyloglossia (tongue-tie) in children aged 3 to 6 years.

Participants are randomly assigned to one of two groups: Experimental Group - Patients undergo lingual frenectomy using a 940 nm diode laser and Active Comparator Group - Patients undergo the procedure using conventional high-frequency electrosurgery.

The study evaluates several key outcomes at multiple intervals (24 hours, 3 days, 1 week, and 1 month post-surgery), including: (1) Wound Healing: Measured by the Early Wound Healing Score (EHS); (2) Pain Levels: Assessed using the Wong-Baker FACES Pain Rating Scale; (3) Bleeding Control: Evaluation of intraoperative bleeding; (4) Tongue Mobility: Measurement of free tongue length according to Kotlow's classification.

The goal is to determine if the diode laser provides superior healing, less pain, and better bleeding control compared to electrosurgery.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Participant Allocation: Participants meeting the inclusion criteria (aged 3-6, diagnosed with Kotlow grade 3 or 4 ankyloglossia) are randomly assigned to one of two groups using a simple randomization method (drawing lots):

  • Group 1 (Laser Group): Lingual frenectomy performed using a 940 nm Diode Laser (Epic X, Biolase) with a power of 1W (average) and 2W (peak) in pulsed mode (CP2).
  • Group 2 (Electrosurgery Group): Lingual frenectomy performed using a high-frequency electrosurgical unit (ERBE-VIO 100C) in continuous contact mode.

Surgical Procedure: Both groups follow a standardized surgical protocol:

  • Anesthesia: Local anesthesia with 2% Lidocaine/Adrenaline (0.45 ml).
  • Technique: Transverse incision without suturing or muscle dissection to release the lingual frenum.
  • Safety Measures: Use of protective eyewear for the laser group and electrode grounding pads for the electrosurgery group.

Data Collection and Blinding:

  • Blinding: This is a single-blind study where the participants and their guardians are unaware of the assigned treatment group. The evaluator measuring post-operative outcomes is also blinded to the surgical method used.

  • Follow-up Schedule: Evaluations are conducted at five specific intervals:

    • Baseline (T0): Pre-operative measurements.
    • Post-operative: At 24 hours (T1), 3 days (T2), 1 week (T3), and 1 month (T4).

Evaluation Criteria:

  • Wound Healing: Assessed by the Early Wound Healing Score (EHS), focusing on re-epithelialization (CSR), haemostasis (CSH), and inflammation (CSI).
  • Pain Intensity: Self-reported by patients using the Wong-Baker FACES Pain Rating Scale.
  • Tongue Function: Measuring the increase in free tongue length (mm) using a Quick Tongue-Tie (QTT) tool.

研究类型

介入性

注册 (估计的)

53

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 越南
      • Ho Chi Minh City、越南
        • 招聘中
        • Children's Hospital 1, Department of Odonto-Stomatology
        • 接触：
        • 首席研究员：
          • Phung Van Ho, DDS
        • 副研究员：
          • Phong Dai Lam, PhD, DDS
      • Ho Chi Minh City、越南
        • 招聘中
        • Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
        • 接触：
        • 副研究员：
          • Phung Van Ho, DDS

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  • Patients aged between 3 and 6 years.
  • Diagnosed with grade 3 or grade 4 ankyloglossia according to Kotlow's classification (1999).
  • Parents or legal guardians provide informed consent for the child to participate in the study.
  • Patients and guardians agree to follow the follow-up schedule (24 hours, 3 days, 1 week, and 1 month post-surgery).

Exclusion Criteria:

  • History of allergy to local anesthetics (e.g., Lidocaine, Adrenaline).
  • Patients with systemic diseases or high-risk surgical factors (e.g., cardiovascular disease, bleeding disorders, hemophilia, epilepsy, or uncontrolled asthma).
  • Uncooperative patients who are unable to undergo the procedure under local anesthesia or fail to follow post-operative instructions.
  • Patients who withdraw from the study before completion.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Diode Laser Group
Patients in this group undergo lingual frenectomy using a 940 nm diode laser (Epic X, Biolase). The procedure is performed using a transverse incision technique without suturing. Laser settings include an average power of 1W, peak power of 2W in pulsed mode (CP2), and a 940 nm wavelength.
程序：Lingual Frenectomy using 940nm Diode Laser
Lingual frenectomy performed using a 940 nm Diode Laser (Epic X, Biolase). The laser is set to pulsed mode (CP2), average power 1W, and peak power 2W. The procedure involves a transverse incision to release the frenum without suturing. Protective eyewear is mandatory for the patient and surgical team.
其他名称：
  • Diode Laser Frenectomy
  • Laser-assisted Frenotomy
有源比较器：Electrosurgery Group
Patients in this group undergo lingual frenectomy using a high-frequency electrosurgical unit (ERBE-VIO 100C). The procedure follows the same transverse incision protocol without suturing as the experimental group.
程序：Lingual Frenectomy using High-frequency Electrosurgery
Lingual frenectomy performed using a high-frequency electrosurgical unit (ERBE-VIO 100C). The procedure follows a standardized transverse incision protocol without suturing. A grounding pad (electrode) is applied to the patient's body to complete the circuit. This serves as the active comparator representing the conventional surgical method at the hospital.
其他名称：
  • Electrosurgical Frenectomy
  • Electrocautery Frenotomy

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Early Wound Healing Score (EHS)
大体时间：24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery.
The EHS is used to evaluate the early healing of periodontal soft tissue wounds. It is the sum of three components: Clinical Signs of Re-epithelialization (CSR), Clinical Signs of Haemostasis (CSH), and Clinical Signs of Inflammation (CSI). The total score ranges from 0 to 10, where a higher score indicates better and faster wound healing (10 being perfect healing).
24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery.

次要结果测量

结果测量
措施说明
大体时间
Pain Intensity assessed by Wong-Baker FACES Pain Rating Scale
大体时间：24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery.
Patients self-assess their pain levels using a scale of 6 faces representing different pain intensities. Scores range from 0 (no pain) to 10 (worst possible pain), with increments of 2 (0, 2, 4, 6, 8, 10).
24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery.
Level of Intraoperative Bleeding
大体时间：During the surgical procedure (T0)
Bleeding is assessed during the surgical procedure and categorized into 2 levels: Grade 1 (No bleeding) and Grade 2 (Bleeding present, requiring local haemostatic measures like gauze pressure or laser/electrosurgery coagulation).
During the surgical procedure (T0)
Increase in Free Tongue Length
大体时间：Baseline (T0), 1 week (T3), and 1 month (T4) post-surgery.
Measured as the distance (in mm) from the attachment of the lingual frenum on the ventral surface of the tongue to the tip of the tongue using a Quick Tongue-Tie (QTT) measurement tool.
Baseline (T0), 1 week (T3), and 1 month (T4) post-surgery.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Medicine and Pharmacy at Ho Chi Minh City

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年10月1日

初级完成 (估计的)

2026年9月30日

研究完成 (估计的)

2026年10月1日

研究注册日期

首次提交

2026年4月22日

首先提交符合 QC 标准的

2026年4月22日

首次发布 (实际的)

2026年4月30日

研究记录更新

最后更新发布 (实际的)

2026年4月30日

上次提交的符合 QC 标准的更新

2026年4月22日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRB00010293-2026

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

The individual participant data will not be shared to ensure absolute confidentiality for the pediatric patients and their families, as stated in the informed consent and study protocol approved by the Ethics Committee.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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