Tongue Mobility in Patients with Ankyloglossia Following Frenectomy

Completed

• Conditions: Ankyloglossia

• Registration Number: NCT06856564
• Lead Sponsor: Hanoi Medical University

Brief Summary

This study aimed to evaluate the improvement in tongue mobility in patients with ankyloglossia (tongue-tie) following frenectomy. Ankyloglossia restricts tongue movement, potentially causing issues with speech, swallowing, and dental malocclusion.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-02
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Study First Posted: 2025-03-04
• Last Update Posted: 2025-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• (1) at least four years of age, (2) report a limitation in tongue mobility at least at the moderate class (class II) according to Kotlow criteria and did not response to tongue lengthening exercise.

Exclusion Criteria

• Patients who have limited mouth openings that interfere with tongue mobility measurements and patients who have bad compliances due to mental problems or uncooperative children were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Kotlow index	3 months	The Kotlow index measures the distance point of attachment of the frenum on the ventral surface of the tongue and the tip of the tongue. This outcome measure will be assessed in millimeters (mm) using the Quick Tongue-Tie (QTT) Assessment Tool.
Tongue-Incisive Papilla Distance	3 months	Tongue-Incisive Papilla (TIP) Distance is the distance between Tongue and Incisive Papilla. Ask the patient to open their mouth and simultaneously keep tongue tip touching the upper central papilla, the distance between upper and lower right central incisors is defined as TIP. This outcome measure will be assessed in millimeters (mm) using the Quick Tongue-Tie (QTT) Assessment Tool.
Comfortable Mouth Opening	3 months	Comfortable Mouth Opening (CMO) is the optimal jaw position during relaxed oral function, measured as the distance between the upper and lower teeth when the patient siting in upright posture, being relax and looking straight forward, and the mouth is naturally open. This outcome measure will be assessed in millimeters (mm) using the Quick Tongue-Tie (QTT) Assessment Tool.
Lingual - Palatal Suction	3 months	Lingual - Palatal Suction (LPS) is the distance between the upper and lower right central incisors when opening while the tongue is elevated to touch the hard palate. This outcome measure will be assessed in millimeters (mm) using the Quick Tongue-Tie (QTT) Assessment Tool.

Trial Locations

Locations (1)

Hanoi National Hospital of Odonto-Stomatology; 🇻🇳 Hanoi, Vietnam