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Tongue Mobility in Patients with Ankyloglossia Following Frenectomy

Evaluation of Tongue Mobility in Patients with Ankyloglossia Following Frenectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06856564
Enrollment
60
Registered
2025-03-04
Start date
2022-12-01
Completion date
2024-12-31
Last updated
2025-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankyloglossia

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.

Interventions

PROCEDUREFrenectomy

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.

Sponsors

Hanoi Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 33 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Kotlow index3 monthsThe 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 Distance3 monthsTongue-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 Opening3 monthsComfortable 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 Suction3 monthsLingual - 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.

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026