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Enrolling By Invitation
NCT07110948
Long-term Follow-up of Infant Frenotomy/Frenectomy Through Early Childhood
Conditions: Ankyloglossia
Sex: All
Ages: 1 Day – 12 Months
Healthy volunteers: No
Enrollment: 500
Sponsor: University of Alberta
Location: Enjoy Dental Edmonton
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.
Eligibility Criteria
Inclusion criteria
* 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
Exclusion criteria
* patients unable to be seen at research clinic annually
* parents unable to take photos of patient's lingual frenum
Source: ClinicalTrials.gov (NCT07110948). StuddyBuddy aggregates publicly available trial information.