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CompletedNCT06856564Updated Sep 24, 2026

Tongue Mobility in Patients With Ankyloglossia Following Frenectomy

An observational study in Ankyloglossia, sponsored by Hanoi Medical University. Completed at 1 site in Vietnam. Open to participants aged 4 Years to 33 Years. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Hanoi Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
4 Years to 33 Years
Sex
All
01

Study summary

This observational study evaluated changes in tongue mobility among patients with ankyloglossia who underwent frenectomy as part of routine clinical care. The decision to perform frenectomy, including the indication and surgical technique, was made by the treating clinician independently of study participation. The study did not assign any treatment. Tongue mobility measurements obtained before treatment and during routine postoperative follow-up were analyzed.

Read the detailed description

This was a prospective observational cohort study of patients with ankyloglossia receiving routine clinical care at Hanoi National Hospital of Odonto-Stomatology and Hanoi Medical University.

Clinical decisions regarding whether frenectomy was indicated, the timing of treatment, and the surgical technique were made by the treating clinicians according to routine clinical practice and independently of enrollment in this study. Participation in the study did not determine or modify the treatment received.

Patients who underwent frenectomy as part of routine clinical care were observed before treatment and during routine postoperative follow-up. Tongue mobility was assessed using the Quick Tongue-Tie (QTT) Assessment Tool, including the Kotlow index, Tongue-Incisive Papilla distance, and Lingual-Palatal Suction measurement.

The objective of the study was to describe changes in tongue mobility following routinely provided frenectomy. No therapeutic intervention was prospectively assigned by the investigators for research purposes.

02

Conditions studied

  • Ankyloglossia

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03

In context

Ankyloglossia

32 studies on the registry are indexed under Ankyloglossia; 8 are open to participants now.

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Lead sponsor

Hanoi Medical University is the lead sponsor of 54 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 33 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 4 years or older with ankyloglossia who had been independently clinically indicated for and received frenectomy as part of routine clinical care were eligible for observation.
  • Patients had at least moderate limitation of tongue mobility (Kotlow class II or greater) and had not responded adequately to tongue-lengthening exercises.

Exclusion criteria

Exclusion Criteria:

  • Patients who have limited mouth openings that interfere with tongue mobility measurements
  • Patients who have bad compliances due to mental problems or uncooperative children were excluded.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Interventions

  • ProcedureFrenectomy

    Frenectomy was performed as part of routine clinical care for patients with ankyloglossia who had a clinical indication for treatment. The decision to perform the procedure, its timing, and the surgical technique were determined by the treating clinician independently of study participation. The study investigators did not assign participants to frenectomy or to a specific surgical technique.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

  3. 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.

    Time frame: 3 months

  4. 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.

    Time frame: 3 months

07

Study locations

1 site
  • Hanoi National Hospital of Odonto-Stomatology
    Hanoi, 10000, Vietnam
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2022 to primary completion in Dec 2024, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 19, 2025
First posted
Mar 4, 2025
StartActual
Dec 1, 2022
Primary completionActual
Dec 31, 2024
CompletionActual
Dec 31, 2024
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06856564
Lead sponsor
Hanoi Medical University
Responsible party
Nguyen Ngoc Hoa (Principal Investigator, Hanoi Medical University) — Principal investigator
First posted
Mar 4, 2025
Start date
Dec 1, 2022
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Sep 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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