Healing Efficacy of Diode Laser in Lingual Frenectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Ankyloglossia; Tongue-tie
• Intervention / Treatment: Procedure: Lingual Frenectomy using 940nm Diode Laser; Procedure: Lingual Frenectomy using High-frequency Electrosurgery

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 53
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Phong Dai Lam, PhD, DDS; Phone Number: (+84) 906312958; Email: phonglam@ump.edu.vn

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam
    • Recruiting
    • Children's Hospital 1, Department of Odonto-Stomatology
    • Contact: Phung Van Ho, DDS; Phone Number: (+84) 983791484; Email: hvphung.ckii.rhm23@ump.edu.vn
    • Principal Investigator: Phung Van Ho, DDS
    • Sub-Investigator: Phong Dai Lam, PhD, DDS
  • Ho Chi Minh City, Vietnam
    • Recruiting
    • Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
    • Contact: Phong Dai Lam, PhD, DDS; Phone Number: (+84) 906312958; Email: phonglam@ump.edu.vn
    • Sub-Investigator: Phung Van Ho, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.; Other Names: Diode Laser Frenectomy; Laser-assisted Frenotomy
Active Comparator: 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.	Procedure: 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.; Other Names: Electrosurgical Frenectomy; Electrocautery Frenotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Wound Healing Score (EHS)	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity assessed by Wong-Baker FACES Pain Rating Scale	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	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	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.

Collaborators and Investigators

• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

Publications and helpful links

General Publications

• Kotlow LA. Ankyloglossia (tongue-tie): a diagnostic and treatment quandary. Quintessence Int. 1999 Apr;30(4):259-62.
• Hwang WB, Kim DJ, Oh GS, Park JH. Aryl Hydrocarbon Receptor Ligands Indoxyl 3-sulfate and Indole-3-carbinol Inhibit FMS-like Tyrosine Kinase 3 Ligand-induced Bone Marrow-derived plasmacytoid Dendritic Cell Differentiation. Immune Netw. 2018 Oct 23;18(5):e35. doi: 10.4110/in.2018.18.e35. eCollection 2018 Oct.
• Mazzoni A, Navarro RS, Fernandes KPS, Mesquita-Ferrari RA, Horliana ACRT, Silva T, Santos EM, Sobral APT, Junior AB, Nammour S, Motta LJ, Bussadori SK. Comparison of the Effects of High-Power Diode Laser and Electrocautery for Lingual Frenectomy in Infants: A Blinded Randomized Controlled Clinical Trial. J Clin Med. 2022 Jun 30;11(13):3783. doi: 10.3390/jcm11133783.

Helpful Links

• University of Medicine and Pharmacy at Ho Chi Minh City - Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Wound healing; Postoperative pain; Diode laser; Electrosurgery; Tongue-tie; Ankyloglossia; Lingual frenectomy; Early Wound Healing Score (EHS); Wong-Baker FACES Pain Rating Scale; Kotlow's classification
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Body Temperature Changes; Heat Stress Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hyperthermia; Ankyloglossia; Pain, Postoperative; Equipment and Supplies; Lasers; Optical Devices; Radiation Equipment and Supplies; Lasers, Semiconductor
• Other Study ID Numbers: IRB00010293-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No