NCT05560750

Brief Summary

Oral cavity's structural variations are involved in the successful breastfeeding of the newborn infants. The tongue-tie has been shown to cause breastfeeding problems. This project investigates the oral structural properties of the newborn infants and the efficacy and safety of their treatment options in breastfeeding problems. The project includes two studies: 1. A prospective follow-up study that investigates the epidemiology and associations between oral structures and breastfeeding problems in term and preterm infants; 2. A randomised, controlled study that investigates the efficacy and safety of tongue-tie treatments. Follow-up visits are planned two to three months, one year, and five years after randomisation along with a 6 months' e-questionnaire for all study patients. The study provides information at the population level.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Oct 2022Dec 2028

First Submitted

Initial submission to the registry

September 21, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

October 3, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2026

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Expected
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

September 21, 2022

Last Update Submit

January 7, 2026

Conditions

Tongue TieFrenulum BreveFrenulum; ElongationBreast Feeding

Keywords

Tongue tieFrenulum lingualisFrenotomyOral physiotherapyNewborn infantBreastfeedingBreastfeeding complicationsLogopedic evaluation

Outcome Measures

Primary Outcomes (1)

  • Successful breastfeeding

    Mother breastfeeding the child w/o problems

    1 month age

Secondary Outcomes (15)

  • Anatomical classification of the frenulum lingualis

    1 month

  • Histological classification of the frenulum lingualis

    1 month

  • Height of the oral cavity

    1 month

  • Width of the jaw

    1 month

  • Breastfeeding problems questionnaire

    1 month

  • +10 more secondary outcomes

Other Outcomes (1)

  • Speech therapy evaluations and their results

    5 years

Study Arms (3)

Frenotomy

EXPERIMENTAL

Patients who will have frenotomy soon after randomisation, on the same or next day

Procedure: Frenotomy

Oral physiotherapy

ACTIVE COMPARATOR

Patients whose parents are guided to give the child oral physiotherapy for 1 month

Procedure: Oral physiotherapy

Follow-up

NO INTERVENTION

Patients whose frenotomy appointment will be set at 1 month age

Interventions

FrenotomyPROCEDURE

Releasing the tongue-tie with scissors

Also known as: Frenulum elongation
Frenotomy
Oral physiotherapyPROCEDURE

Gentle parental activation of the mouth area and the tongue for 1 month

Oral physiotherapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Newborn infant with at tongue-tie interfering the breastfeeding and patient's study screening scoring exceeding \>8/19

You may not qualify if:

  • Child's severe anomaly or illness; the parent's severe illness; a communication problem between parents and researchers (e.g. language barrier); any other practical reason that prevents the child to have the procedure or the parents to provide the oral physiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Otorhinolaryngology, Oulu University Hospital

Oulu, Finland

Location

Department of Pediatrics, Oulu University Hospital

Oulu, Finland

Location

University of Oulu, Faculty of Humanities, Research Unit of Logopedics

Oulu, Finland

Location

Related Links

MeSH Terms

Conditions

AnkyloglossiaBreast Feeding

Interventions

Oral FrenectomyPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Stomatognathic DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistryTherapeuticsRehabilitation

Study Officials

  • Outi Aikio, MD, PhD

    Oulu University Hospital, Dept of Pediatrics; PEDEGO Research unit and MRC Oulu, University of Oulu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
One month follow-up time (parents unaware)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study patients with parental consent are randomized into 3 study arms: 1. Open study treatment (index therapy) is a frenotomy performed under local anesthesia or general anesthesia, i.e. an operation to release the lingual frenulum immediately after its detection; 2. Conservative treatment is a parental given sensitive movement therapy aiming to tongue-tie stretching for 4 weeks; 3. Follow-up group (no-treatment): appointment for the procedure at one month age with a re-evaluation for the procedure.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2022

First Posted

September 29, 2022

Study Start

October 3, 2022

Primary Completion

January 23, 2026

Study Completion (Estimated)

December 31, 2028

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FI(3)