AnkyloglossiaNCT06856564
Tongue Mobility in Patients With Ankyloglossia Following Frenectomy
An observational study of Ankyloglossia, run by Hanoi Medical University at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 33 years
- Conditions the study is for
- Ankyloglossia
- What is being tested?
- Frenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Dec 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 33 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients at Hanoi National Hospital of Odonto-stomatology and Hanoi Medical University from December 2022 to December 2024
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Tongue Mobility in Patients With Ankyloglossia Following Frenectomy
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.
- Conditions
- Ankyloglossia
- Being tested
- Frenectomy
- Medical subject headings
- Ankyloglossia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FrenectomyProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 Dec 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnkyloglossiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Ngoc Hoa, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856564
- Sponsor's protocol ID
- 1104
- Status last verified
- Sep 2026
- First submitted
- 19 Feb 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tongue Mobility in Patients With Ankyloglossia Following Frenectomy
- ClinicalTrials.gov ID
- NCT06856564
- Acronym / sponsor ID
- 1104
- Conditions
- Ankyloglossia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 33 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients at Hanoi National Hospital of Odonto-stomatology and Hanoi Medical University from December 2022 to December 2024
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FrenectomyFrenectomy 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. | Procedure or surgery | – |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Yes
Related trials for Ankyloglossia
Recruiting
Effectivity of P1821, a Novel Tongue Strengthening and Endurance Enhancing Speech Flow Exercise
Ankyloglossia, Impairment of Speech
Enrolling by invitationObservational study
Long-term Follow-up of Infant Frenotomy/Frenectomy Through Early Childhood
Ankyloglossia
Not yet recruiting
SNIP follow-on Case Series Using v3 Device
Ankyloglossia
Not yet recruitingObservational study
Ankyloglossia and Breastfeeding
Ankyloglossia, Breastfeeding
Recruiting
The Impact of Post-Frenotomy Massages on Ankyloglossia Recurrence and Feeding Outcomes
Ankyloglossia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankyloglossia, run by Hanoi Medical University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kotlow index (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.