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

NCT07110948 | Enrolling By Invitation

• 1 other identifier: HREBA CTC-24-0121
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

observation

Outcome Measures

Primary Outcomes (1)

• 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.

  6 years

Study Arms (1)

Observational

Observational after TT release

Procedure: Tongue tie release

Interventions

Tongue tie release PROCEDURE

surgical release of tongue tie

Observational

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants who have had tongue tie release completed with appropriate documentation per protocol Infants may be referred for tongue tie release procedure

You may qualify if:

• 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

You may not qualify if:

• patients unable to be seen at research clinic annually
• parents unable to take photos of patient's lingual frenum

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Enjoy Dental

Edmonton, Canada

Location

MeSH Terms

Conditions

Ankyloglossia

Interventions

Oral Frenectomy

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: August 8, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)