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Enrolling by invitationOBSERVATIONAL

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

This study is investigating the long-term effects of a procedure called 'tongue tie release' (also known as frenectomy) in babies and young children. Tongue tie is when a small piece of skin under the tongue restricts its movement, which can cause problems with breastfeeding. While this procedure is becoming more common, doctors don't fully understand its long-term benefits or if other issues like speech or future dental problems might arise. This research aims to collect important information to help plan future studies and improve care for children with tongue tie. It looks at how children develop over time after having their tongue tie released, focusing on feeding, speech, and wider health concerns.

At a glance

Status
Enrolling by invitation
Sponsor
University of Alberta
Enrolment target
500
Start
01 Jun 2025
Estimated completion
01 Dec 2030

What is this study about?

You might have heard of a ‘tongue tie’, especially if you have a baby. It happens when the skin under the tongue, called the frenum, is shorter than usual, making it hard for the tongue to move freely. For babies, this can often lead to difficulties with breastfeeding, such as trouble latching onto the breast or sucking properly. This can make feeding tiring and frustrating for both the baby and the parent, sometimes causing nipple pain for the mother.

At the moment, we don't know much about what happens to children with a tongue tie over a long period if it's not treated, or what the long-term effects are of having the tongue tie released. Releasing the tongue tie, often called a frenectomy, involves a small operation to snip this piece of skin. While many babies have this procedure, doctors need more information about how it affects children's development as they get older, including their feeding habits, speech, and even how their teeth grow or how they sleep.

This study aims to start gathering this missing information. By carefully observing children who had a tongue tie release as babies, researchers hope to understand more about how they develop over time. This will help doctors make better decisions about when and how to treat tongue ties and will guide future, more detailed research into this common condition.

Key takeaways

  • The study looks at long-term effects of tongue tie release in babies.
  • It aims to understand development related to feeding, speech, and general health.
  • There’s currently limited research on long-term outcomes of this common procedure.
  • Eligible babies are those aged 1 day to 12 months who have had a tongue tie release.
  • Participation involves annual clinic visits and taking photos of your child's tongue.

Who may be eligible?

This study is looking for babies who have had a tongue tie release operation. To be included, babies must have been checked by a doctor, nurse, or breastfeeding specialist before their tongue tie was released.

Also, certain details about their tongue tie, the mother's feeding problems, and how the wound was cared for after the operation must have been properly recorded. Importantly, the researchers need to be able to keep track of the patient's records through a system called AHS PRAC-ID.

Babies can't join the study if their parents aren't able to take photos of their child's tongue area or if they can't attend appointments at the research clinic once a year. The study is open to both boys and girls from birth up to 12 months old.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Was your baby between 1 day and 12 months old when they had their tongue tie released?
  2. Was your baby seen by a doctor, nurse, or breastfeeding specialist before the tongue tie release?
  3. Are you able to attend appointments at the research clinic once a year?
  4. Are you able to take photos of your baby's tongue area when asked?
Answer every question to see your result.

What does participation involve?

If you and your baby join this study, it means your child will be followed up over several years. This will involve annual visits to the research clinic. During these visits, the researchers will likely check your child's tongue movement, their feeding, and ask questions about their development, including speech. You will also be asked to take regular photos of your child's tongue area. The study is observational, meaning there are no new medications or treatments given as part of the research. It simply involves observing and collecting information about children who have already had a tongue tie release.

Potential risks and benefits

Potential benefits of taking part include helping doctors understand more about tongue ties and their treatment, which could improve care for future children. There are no direct medical benefits to your child from participating. Risks are minimal, mainly involving the time commitment for clinic visits and taking photos. All gathered information will be kept confidential. You are free to withdraw your child from the study at any time without giving a reason, and this will not affect your child's medical care in any way.

Locations (1)

  • Enjoy Dental
    Verified postcode
    Edmonton, Canada

Common questions

What is a 'tongue tie'?

A tongue tie is when the skin under the tongue is too short, restricting the tongue's movement.

What does 'tongue tie release' involve?

It's a small operation, sometimes called a frenectomy, to snip the short piece of skin under the tongue.

Why is this study important?

It will help doctors understand the long-term effects of tongue tie release and improve care for babies with this condition.

Will my baby receive any new treatment?

No, this study is observational, meaning it only collects information and doesn't involve new treatments or medications.

How long will my child be part of the study?

The study involves annual follow-up visits, so it will continue over several years.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Long-term Follow-up of Infant Frenotomy/Frenectomy Through E…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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