Tongue Mobility in Patients with Ankyloglossia Following Frenectomy

Evaluation of Tongue Mobility in Patients with Ankyloglossia Following Frenectomy

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.

Study Overview

• Status: Completed
• Conditions: Ankyloglossia
• Intervention / Treatment: Procedure: Frenectomy

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam, 10000
    • Hanoi National Hospital of Odonto-Stomatology

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients at Hanoi National Hospital of Odonto-stomatology and Hanoi Medical University from December 2022 to December 2024

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kotlow index	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.	3 months
Tongue-Incisive Papilla Distance	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.	3 months
Comfortable Mouth Opening	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.	3 months
Lingual - Palatal Suction	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.	3 months

Collaborators and Investigators

• Sponsor: Hanoi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Ankyloglossia
• Other Study ID Numbers: 1104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No