Actively Recruiting

Phase Not Applicable
Age: 3Years - 6Years
All Genders
NCT07557875

Healing Efficacy of Diode Laser in Lingual Frenectomy

Led by University of Medicine and Pharmacy at Ho Chi Minh City · Updated on 2026-04-30

53

Participants Needed

2

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Healing Efficacy of Diode Laser in Lingual Frenectomy

Who Can Participate

Age: 3Years - 6Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged between 3 and 6 years
  • Diagnosed with grade 3 or grade 4 ankyloglossia according to Kotlow's classification
  • Parents or legal guardians provide informed consent for participation
  • Patients and guardians agree to follow the follow-up schedule at 24 hours, 3 days, 1 week, and 1 month post-surgery
Not Eligible

You will not qualify if you...

  • History of allergy to local anesthetics such as Lidocaine or Adrenaline
  • Presence of systemic diseases or high-risk surgical factors including cardiovascular disease, bleeding disorders, hemophilia, epilepsy, or uncontrolled asthma
  • Uncooperative patients unable to undergo the procedure under local anesthesia or follow post-operative instructions
  • Patients who withdraw from the study before completion

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Children's Hospital 1, Department of Odonto-Stomatology

Ho Chi Minh City, Vietnam

Actively Recruiting

2

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

Ho Chi Minh City, Vietnam

Actively Recruiting

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Research Team

P

Phong Dai Lam, PhD, DDS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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