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Long-term Follow-up of Infant Frenotomy/Frenectomy Through Early Childhood

NCT07110948 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-08-08

No results posted yet for this study

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. 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.

Conditions

  • Ankyloglossia

Interventions

PROCEDURE

Tongue tie release

surgical release of tongue tie

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Eligibility

Min Age
1 Day
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07110948 on ClinicalTrials.gov