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Completed

NCT Number: NCT06856564

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.

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Key information

Conditions

Ankyloglossia Stomatognathic Diseases

Age range

4 year–33 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hanoi National Hospital of Odonto-Stomatology

Hanoi, 10000, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Kotlow index

    Time frame: 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.

  2. Tongue-Incisive Papilla Distance

    Time frame: 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.

  3. Comfortable Mouth Opening

    Time frame: 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.

  4. Lingual - Palatal Suction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hanoi Medical University

Other

Registry information

Official study title

Evaluation of Tongue Mobility in Patients with Ankyloglossia Following Frenectomy

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 4, 2025
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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