Healing Efficacy of Diode Laser in Lingual Frenectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-6
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Lingual Frenectomy using 940nm Diode Laser
Procedure/SurgeryLingual 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.
Lingual Frenectomy using High-frequency Electrosurgery
Procedure/SurgeryLingual 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.
Treatment groups
53 Participants
are divided into 2 treatment groupsGroup A: Diode Laser GroupExperimental treatment 1 intervention
Group B: Electrosurgery GroupActive comparator 1 intervention
Trial outcomes
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).
Time frame
24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery.Secondary outcomes
1
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).
Time frame
24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery.2
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).
Time frame
During the surgical procedure (T0)3
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.
Time frame
Baseline (T0), 1 week (T3), and 1 month (T4) post-surgery.Sponsors and contacts
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Source ClinicalTrials.gov