AnkyloglossiaNCT07110948
Long-term Follow-up of Infant Frenotomy/Frenectomy Through Early Childhood
An observational study of Ankyloglossia, run by University of Alberta at 1 site in Canada.
Trial summary
Ankyloglossia (tongue tie) is an anatomically shortened lingual frenum that impairs appropriate tongue mobility. Initial clinical diagnosis of tongue tie usually begins during infancy with abnormal breastfeeding though not all infants with a tongue tie may exhibit difficulties with breastfeeding. Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Ankyloglossia
- What is being tested?
- Tongue tie release
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2025to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants who have had tongue tie release completed with appropriate documentation per protocol Infants may be referred for tongue tie release procedure
Who may be able to join
- Infants who have undergone lingual frenectomy
- Infants must have been evaluated by a physician/nurse practitioner/lactation consultant prior to lingual frenectomy.
- referral tracking with AHS PRAC-ID
- mother symptomology documented
- frenal attachment classification documented
- Post-surgical wound management documented
Who cannot join
- patients unable to be seen at research clinic annually
- parents unable to take photos of patient's lingual frenum
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Ankyloglossia (tongue tie) is an anatomically shortened lingual frenum that impairs appropriate tongue mobility. Initial clinical diagnosis of tongue tie usually begins during infancy with abnormal breastfeeding though not all infants with a tongue tie may exhibit difficulties with breastfeeding. Breastfeeding may be impacted during both the latch and suckle phases. Normal latch requires anterior thrust of the tongue past the mandible with the tongue extending out inferior to the mother's nipple and breast. Normal suckle requires tongue elevation including along the entire palate to form sufficient suction force for milk expression from the breast. An tongue tie limiting anterior mobility may inhibit the ability of the tongue to extend anteriorly for appropriate latch, while a tongue tie limiting mid-tongue elevation may impeded the ability of the tongue to elevate to the palate and form sufficient suction force for appropriate suckle. In either situation, symptoms including poor latch, poor suckle, tiredness, extended feeding time, and for the mother nipple pain, tiredness, and frustration are common.
To our knowledge there is no self-correction for ankyloglossia. The frenum does not disappear or become less restrictive on its own over time. Frequency of functional adaptation is now known. Prevalence of ankyloglossia ranges up to 16% depending on population studied, with averages hovering between 8-12%, with males more likely than females to have a tongue tie. While the prevalence of tongue tie has been studied, there is minimal research on the rate of frenectomy for patients with tongue tie. There is also minimal research on the long term effects of infant frenectomy, including on the indications/need for revision surgery for children experiencing difficulties in feeding/transition to solids, speech, malocclusion and/or sleep and breathing concerns. With the increasing popularity of frenectomy, especially in infants, long term research is necessary. However, due to the lack of existing research an initial observational trial to gather preliminary data to allow for more appropriate planning of future research is indicated.
Read the detailed description
Ankyloglossia (tongue tie) is an anatomically shortened lingual frenum that impairs appropriate tongue mobility. Initial clinical diagnosis of tongue tie usually begins during infancy with abnormal breastfeeding though not all infants with a tongue tie may exhibit difficulties with breastfeeding. Breastfeeding may be impacted during both the latch and suckle phases. Normal latch requires anterior thrust of the tongue past the mandible with the tongue extending out inferior to the mother's nipple and breast. Normal suckle requires tongue elevation including along the entire palate to form sufficient suction force for milk expression from the breast. An tongue tie limiting anterior mobility may inhibit the ability of the tongue to extend anteriorly for appropriate latch, while a tongue tie limiting mid-tongue elevation may impeded the ability of the tongue to elevate to the palate and form sufficient suction force for appropriate suckle. In either situation, symptoms including poor latch, poor suckle, tiredness, extended feeding time, and for the mother nipple pain, tiredness, and frustration are common.
Tongue tie may also affect swallowing after infancy. Tongue ties can limit tongue extension in the transition from feeding to swallowing and result in poor tongue-jaw dissociation resulting in dysphagia. Restrictions to tongue movement can adversely impact the ability for mastication and lateralization of the bolus leading to greater bolus spread. This can result in poor bolus organization and residue in the vestibules, on the cheeks, and/or retained on tooth surfaces. Limitations to tongue movement, and poor tongue-jaw dissociation, can also create difficulties in recognition of residue in these spaces and the removal of residue from these spaces. Tongue tie can also result in limited mid-tongue elevation, affecting the ability to create appropriate pressure and suction power during the oral phase of swallow to propel the bolus into the pharynx. This may result in compensations to bolus formation to allow for swallowing and/or in residue on the soft palate and/or dorsum of the tongue. Residual infantile swallow from tongue tie may also result in a variety of compensations including anterior or posterior tongue thrusting to provide a relative anchored position to achieve enough tongue pressure in bolus transfer from oral to pharyngeal phases. Poor tongue-jaw dissociation resulting from tongue tie may result in poor tongue muscle tone and endurance, resulting in long term muscular compensations including recruitment of lip, cheek, jaw, and neck muscles for swallowing. This may appear as food aversions, texture preferences and challenges in oral to pharyngeal phase swallowing.
Tongue tie can also adversely affect speech, especially in instances where the tongue tie results in poor tongue-jaw dissociation with significant muscular compensations. Tongue tie restricting anterior movement can limit tongue tip elevation leading to speech sound distortions and/or sound substitutions. Limitations to tongue tip elevation to or near the incisive papillae can lead to tongue tip depression with compensatory use of the blade of the tongue for sound production resulting in a wider column of airflow in speech sounds production. In instances of tongue tie with medial restriction and restrictions to mid tongue elevation, the lateral borders of the tongue may fail to elevate during the production of lingual alveolar and palatal sounds. As the center of the tongue will need to elevate in compensation, this can result in lateral distortions. The tongue tie will also result in elevation of the mandible leading to long term overuse of jaw stabilization muscles. This can display as patients reporting generalized mouth and/or jaw muscle fatigue and/or unclear speech progressively worsening with extended use.
The tongue is also a significant muscle in facial development, occlusion, and airway patency. Restrictions to appropriate tongue mobility are associated with dental malocclusion including dental crowding, Class 2 and Class 3 dental malocclusions, loss of maxillary intercanine space, anterior openbite, and increased mandibular incisor spacing, and gingiva recession. Tongue tie has also been associated with maxillary hypoplasia and soft palate elongation. In some cases, tongue tie revision with appropriate orofacial myofunctional therapy has been shown to help improve existing malocclusion without orthodontic intervention
To our knowledge there is no self-correction for ankyloglossia. The frenum does not disappear or become less restrictive on its own over time. Frequency of functional adaptation is now known. Prevalence of ankyloglossia ranges up to 16% depending on population studied, with averages hovering between 8-12%, with males more likely than females to have a tongue tie. While the prevalence of tongue tie has been studied, there is minimal research on the rate of frenectomy for patients with tongue tie. There is also minimal research on the long term effects of infant frenectomy, including on the indications/need for revision surgery for children experiencing difficulties in feeding/transition to solids, speech, malocclusion and/or sleep and breathing concerns. With the increasing popularity of frenectomy, especially in infants, long term research is necessary. However, due to the lack of existing research an initial observational trial to gather preliminary data to allow for more appropriate planning of future research is indicated.
- Conditions
- Ankyloglossia
- Being tested
- Tongue tie release
- Keywords
- observation
- Medical subject headings
- Ankyloglossia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongue tie releaseProcedure or surgery
surgical release of tongue tie
| Study group | Role | What they receive |
|---|---|---|
| Observational | Observational after TT release Receives: Procedure: Tongue tie release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experienced difficulties in function from limitations to tongue range of motion
The primary objective of this study is to explore the rate at which children who had frenectomy in infancy for the purposes of improving breastfeeding experience difficulties in transition to solids feeding, speech, occlusal development, and/or sleep and breathing necessitating referral for further evaluation related to tongue movement restriction.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Jun 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
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.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110948
- Sponsor's protocol ID
- HREBA CTC-24-0121
- Status last verified
- Sep 2026
- First submitted
- 2 Jul 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Infant Frenotomy/Frenectomy Through Early Childhood
- ClinicalTrials.gov ID
- NCT07110948
- Acronym / sponsor ID
- HREBA CTC-24-0121
- Conditions
- Ankyloglossia
- Keywords
- observation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 8 Aug 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.
Ankyloglossia (tongue tie) is an anatomically shortened lingual frenum that impairs appropriate tongue mobility. Initial clinical diagnosis of tongue tie usually begins during infancy with abnormal breastfeeding though not all infants with a tongue tie may exhibit difficulties with breastfeeding. Breastfeeding may be impacted during both the latch and suckle phases. Normal latch requires anterior thrust of the tongue past the mandible with the tongue extending out inferior to the mother's nipple and breast. Normal suckle requires tongue elevation including along the entire palate to form sufficient suction force for milk expression from the breast. An tongue tie limiting anterior mobility may inhibit the ability of the tongue to extend anteriorly for appropriate latch, while a tongue tie limiting mid-tongue elevation may impeded the ability of the tongue to elevate to the palate and form sufficient suction force for appropriate suckle. In either situation, symptoms including poor latch, poor suckle, tiredness, extended feeding time, and for the mother nipple pain, tiredness, and frustration are common.
To our knowledge there is no self-correction for ankyloglossia. The frenum does not disappear or become less restrictive on its own over time. Frequency of functional adaptation is now known. Prevalence of ankyloglossia ranges up to 16% depending on population studied, with averages hovering between 8-12%, with males more likely than females to have a tongue tie. While the prevalence of tongue tie has been studied, there is minimal research on the rate of frenectomy for patients with tongue tie. There is also minimal research on the long term effects of infant frenectomy, including on the indications/need for revision surgery for children experiencing difficulties in feeding/transition to solids, speech, malocclusion and/or sleep and breathing concerns. With the increasing popularity of frenectomy, especially in infants, long term research is necessary. However, due to the lack of existing research an initial observational trial to gather preliminary data to allow for more appropriate planning of future research is indicated.
Detailed description
Ankyloglossia (tongue tie) is an anatomically shortened lingual frenum that impairs appropriate tongue mobility. Initial clinical diagnosis of tongue tie usually begins during infancy with abnormal breastfeeding though not all infants with a tongue tie may exhibit difficulties with breastfeeding. Breastfeeding may be impacted during both the latch and suckle phases. Normal latch requires anterior thrust of the tongue past the mandible with the tongue extending out inferior to the mother's nipple and breast. Normal suckle requires tongue elevation including along the entire palate to form sufficient suction force for milk expression from the breast. An tongue tie limiting anterior mobility may inhibit the ability of the tongue to extend anteriorly for appropriate latch, while a tongue tie limiting mid-tongue elevation may impeded the ability of the tongue to elevate to the palate and form sufficient suction force for appropriate suckle. In either situation, symptoms including poor latch, poor suckle, tiredness, extended feeding time, and for the mother nipple pain, tiredness, and frustration are common.
Tongue tie may also affect swallowing after infancy. Tongue ties can limit tongue extension in the transition from feeding to swallowing and result in poor tongue-jaw dissociation resulting in dysphagia. Restrictions to tongue movement can adversely impact the ability for mastication and lateralization of the bolus leading to greater bolus spread. This can result in poor bolus organization and residue in the vestibules, on the cheeks, and/or retained on tooth surfaces. Limitations to tongue movement, and poor tongue-jaw dissociation, can also create difficulties in recognition of residue in these spaces and the removal of residue from these spaces. Tongue tie can also result in limited mid-tongue elevation, affecting the ability to create appropriate pressure and suction power during the oral phase of swallow to propel the bolus into the pharynx. This may result in compensations to bolus formation to allow for swallowing and/or in residue on the soft palate and/or dorsum of the tongue. Residual infantile swallow from tongue tie may also result in a variety of compensations including anterior or posterior tongue thrusting to provide a relative anchored position to achieve enough tongue pressure in bolus transfer from oral to pharyngeal phases. Poor tongue-jaw dissociation resulting from tongue tie may result in poor tongue muscle tone and endurance, resulting in long term muscular compensations including recruitment of lip, cheek, jaw, and neck muscles for swallowing. This may appear as food aversions, texture preferences and challenges in oral to pharyngeal phase swallowing.
Tongue tie can also adversely affect speech, especially in instances where the tongue tie results in poor tongue-jaw dissociation with significant muscular compensations. Tongue tie restricting anterior movement can limit tongue tip elevation leading to speech sound distortions and/or sound substitutions. Limitations to tongue tip elevation to or near the incisive papillae can lead to tongue tip depression with compensatory use of the blade of the tongue for sound production resulting in a wider column of airflow in speech sounds production. In instances of tongue tie with medial restriction and restrictions to mid tongue elevation, the lateral borders of the tongue may fail to elevate during the production of lingual alveolar and palatal sounds. As the center of the tongue will need to elevate in compensation, this can result in lateral distortions. The tongue tie will also result in elevation of the mandible leading to long term overuse of jaw stabilization muscles. This can display as patients reporting generalized mouth and/or jaw muscle fatigue and/or unclear speech progressively worsening with extended use.
The tongue is also a significant muscle in facial development, occlusion, and airway patency. Restrictions to appropriate tongue mobility are associated with dental malocclusion including dental crowding, Class 2 and Class 3 dental malocclusions, loss of maxillary intercanine space, anterior openbite, and increased mandibular incisor spacing, and gingiva recession. Tongue tie has also been associated with maxillary hypoplasia and soft palate elongation. In some cases, tongue tie revision with appropriate orofacial myofunctional therapy has been shown to help improve existing malocclusion without orthodontic intervention
To our knowledge there is no self-correction for ankyloglossia. The frenum does not disappear or become less restrictive on its own over time. Frequency of functional adaptation is now known. Prevalence of ankyloglossia ranges up to 16% depending on population studied, with averages hovering between 8-12%, with males more likely than females to have a tongue tie. While the prevalence of tongue tie has been studied, there is minimal research on the rate of frenectomy for patients with tongue tie. There is also minimal research on the long term effects of infant frenectomy, including on the indications/need for revision surgery for children experiencing difficulties in feeding/transition to solids, speech, malocclusion and/or sleep and breathing concerns. With the increasing popularity of frenectomy, especially in infants, long term research is necessary. However, due to the lack of existing research an initial observational trial to gather preliminary data to allow for more appropriate planning of future research is indicated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Procedure: Tongue tie releaseObservational after TT release |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants who have had tongue tie release completed with appropriate documentation per protocol Infants may be referred for tongue tie release procedure
Key inclusion criteria (6 listed)
- Infants who have undergone lingual frenectomy
- Infants must have been evaluated by a physician/nurse practitioner/lactation consultant prior to lingual frenectomy.
- referral tracking with AHS PRAC-ID
- mother symptomology documented
- frenal attachment classification documented
Key exclusion criteria (2 listed)
- patients unable to be seen at research clinic annually
- parents unable to take photos of patient's lingual frenum
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 |
|---|---|---|
| Tongue tie releasesurgical release of tongue tie | Procedure or surgery | Observational |
Primary outcome
Experienced difficulties in function from limitations to tongue range of motion
Time frame: 6 years
The primary objective of this study is to explore the rate at which children who had frenectomy in infancy for the purposes of improving breastfeeding experience difficulties in transition to solids feeding, speech, occlusal development, and/or sleep and breathing necessitating referral for further evaluation related to tongue movement restriction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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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.
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 University of Alberta at 1 site in Canada.
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 6 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: enrolling by invitation, as of the sponsor's last update on 16 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Experienced difficulties in function from limitations to tongue range of motion (time frame: 6 years). 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 16 Sep 2026.