Tongue Mobility in Patients with Ankyloglossia Following Frenectomy

NCT06856564 | Completed

• 1 other identifier: 1104
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankyloglossia

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

Frenectomy PROCEDURE

The study involves using a diode laser and scalpel to treat ankyloglossia in cases that are unresponsive to tongue exercises or exhibit severe restrictions. The techniques employed range from simple frenotomy to complex frenuloplasty, depending on the severity of the condition. Electrocautery is frequently used to minimize bleeding, although it may result in scar formation.

Eligibility Criteria

• Age: 4 Years - 33 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanoi Medical University: lead

Study Sites (1)

Hanoi National Hospital of Odonto-Stomatology

Hanoi, 10000, Vietnam

Location

MeSH Terms

Conditions

Ankyloglossia

Interventions

Oral Frenectomy

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, MDS

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 4, 2025
• Study Start: December 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

VN (1)