Healing Efficacy of Diode Laser in Lingual Frenectomy

NCT07557875 | Recruiting

• 1 other identifier: IRB00010293-2026
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Tongue-tie; Ankyloglossia

Keywords

Ankyloglossia; Tongue-tie; Lingual frenectomy; Diode laser; Electrosurgery; Wound healing; Postoperative pain; Early Wound Healing Score (EHS); Wong-Baker FACES Pain Rating Scale; Kotlow's classification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain Intensity assessed by Wong-Baker FACES Pain Rating Scale

  24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery.

• Level of Intraoperative Bleeding

  During the surgical procedure (T0)

• Increase in Free Tongue Length

  Baseline (T0), 1 week (T3), and 1 month (T4) post-surgery.

Study Arms (2)

Diode Laser Group

EXPERIMENTAL

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

Electrosurgery Group

ACTIVE COMPARATOR

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

Interventions

Lingual Frenectomy using 940nm Diode Laser PROCEDURE

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.

Also known as: Diode Laser Frenectomy, Laser-assisted Frenotomy

Diode Laser Group

Lingual Frenectomy using High-frequency Electrosurgery PROCEDURE

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.

Also known as: Electrosurgical Frenectomy, Electrocautery Frenotomy

Electrosurgery Group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Children's Hospital 1, Department of Odonto-Stomatology

Ho Chi Minh City, Vietnam

RECRUITING

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

Ho Chi Minh City, Vietnam

RECRUITING

Related Publications (3)

• Kotlow LA. Ankyloglossia (tongue-tie): a diagnostic and treatment quandary. Quintessence Int. 1999 Apr;30(4):259-62.

  PMID: 10635253 BACKGROUND

• 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.

  PMID: 30402330 BACKGROUND

• 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.

  PMID: 35807068 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Ankyloglossia; Hyperthermia; Pain, Postoperative

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Phong Dai Lam, PhD, DDS

CONTACT

(+84) 906312958; phonglam@ump.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The study is designed as a single-blind trial to minimize bias in outcome assessment. The masking procedures are implemented as follows: * Participants and Legal Guardians: To maintain masking, the surgical procedures are performed under similar clinical settings. The specific equipment (Diode Laser or Electrosurgical unit) is not disclosed to the children or their parents before, during, or after the procedure. * Outcomes Assessor: A dedicated evaluator, who is responsible for measuring the free tongue length, assessing pain levels via the Wong-Baker scale, and calculating the Early Wound Healing Score (EHS), is strictly masked to the treatment allocation. This assessor is not present during the surgery and only performs evaluations at scheduled follow-up intervals. * Data Analyst: The individuals involved in the statistical analysis will process the data using coded group identifiers (e.g., Group 1 and Group 2) without knowledge of which code corresponds to the laser or electrosurger
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Oral and Maxillofacial Radiology, Faculty of Dentistry

Model Details: The study utilizes a parallel-group, randomized clinical trial design with a 1:1 allocation ratio. Participants are assigned to either the experimental group or the control group using a simple randomization method (drawing lots). * Randomization: A total of 50 lots are prepared, divided into two equal sets marked with numbers "1" and "2". Each participant draws one lot to determine their treatment group. * Allocation: Group 1 (Experimental): Participants who draw lot "1" undergo lingual frenectomy using a 940 nm diode laser. Group 2 (Control): Participants who draw lot "2" undergo the procedure using high-frequency electrosurgery. * Blinding: This is a single-blind study. Participants and their legal guardians are blinded to the assigned surgical method. To ensure objective results, the outcome evaluator is also blinded to the participant's treatment group.

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 30, 2026
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)