Evaluation of the Effects of Tongue-Tie and Upper Lip-Tie

NCT06826482 | Completed

• 1 other identifier: 26379996/06
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Tongue-tie and upper-lip tie have been linked to breastfeeding difficulties; however, the traditional evaluation tools that provide this information rely primarily on subjective assessments. In this context, ultrasound imaging has enabled an objective assessment of the sucking dynamics of infants. The aim of this study was to assess the impact of tongue-tie and upper lip-tie on sucking function in newborns via ultrasonography and other tools. Methods: This prospective cohort study included 67 newborns (25 with tongue-tie, 21 with upper lip-tie, and 21 control) as well as their mothers. The maxillary labial frenulum was evaluated according to Kotlow, and the lingual frenulum was evaluated according to the Tongue Tie and Breastfed Infants (TABBY) tool. Sucking functions were examined via ultrasonography between postnatal days 5 and 15. Breastfeeding was evaluated via the LATCH tool, and maternal nipple pain was graded via a numerical rating scale. Mothers were interviewed by telephone about their breastfeeding continuity in the 1st month after birth. The data were analyzed through descriptive and inferential statistics and association tests.

Conditions

Tongue-tie; Upper Lip-tie

Keywords

Tongue-tie; upper lip-tie; breastfeeding; ultrasonography; newborn

Outcome Measures

Primary Outcomes (10)

• Distance between the nipple (N) and the hard-soft palate junction

  During sucking, while the tongue is positioned both upward and downward, the distance between the nipple (N) and the hard-soft palate junction (HSPJ) was measured via ultrasound imaging.

  Between the 5th and 15th days after birth.

• Intraoral space dept

  During sucking, while the tongue is positioned both upward and downward, the intraoral space dept (the distance from the HSPJ to the surface of the mid-tongue) was measured via ultrasound imaging.

  Between the 5th and 15th days after birth.

• Nipple diameter (ND) at 2 mm from the tip of the nipple.

  During sucking, while the tongue is positioned both upward and downward, the nipple diameter (ND) at 2 mm from the tip of the nipple was measured via ultrasound imaging.

  Between the 5th and 15th days after birth.

• Nipple diameter (ND) at 5 mm from the tip of the nipple.

  During sucking, while the tongue is positioned both upward and downward, the nipple diameter (ND) at 5 mm from the tip of the nipple was measured via ultrasound imaging.

  Between the 5th and 15th days after birth.

• Nipple diameter (ND) at 10 mm from the tip of the nipple.

  During sucking, while the tongue is positioned both upward and downward, the nipple diameter (ND) at 10 mm from the tip of the nipple was measured via ultrasound imaging.

  Between the 5th and 15th days after birth.

• Nipple diameter (ND) at 15 mm from the tip of the nipple.

  During sucking, while the tongue is positioned both upward and downward, the nipple diameter (ND) at 15 mm from the tip of the nipple was measured via ultrasound imaging.

  Between the 5th and 15th days after birth.

• Anterior-tongue height

  During sucking, while the tongue is positioned both upward and downward, the anterior-tongue height (the distance between the dorsal surface of the anterior-tongue and the inferior border of the genioglossus muscle) was measured via ultrasound imaging.

  Between the 5th and 15th days after birth.

• Mid-tongue height

  During sucking, while the tongue is positioned both upward and downward, the mid-tongue height (the distance between the dorsal surface of the mid-tongue and the inferior border of the genioglossus muscle) was measured via ultrasound imaging.

  Between the 5th and 15th days after birth.

• LATCH scores

  Breastfeeding was assessed via the LATCH tool. This tool consists of 5 items that score latch, audible swallowing, type of nipple, comfort, and hold (positioning). Each item is evaluated on a scale of 0-2 points. The highest possible total score that can be obtained from the LATCH assessment tool is 10. A high score indicates greater success in breastfeeding.

  Between the 5th and 15th days after birth (at the ultrasound appointment)

• Maternal nipple pain

  Maternal nipple pain was graded via a numerical rating scale. A score of 0 indicated "absence of pain," and a score of 10 indicated "presence of unbearable pain".

  Between the 5th and 15th days after birth (at the ultrasound appointment) and the 1st month after birth (questioned at a telephone interview).

Other Outcomes (13)

• Maternal age

  Baseline

• Maternal chronic diseases

  Baseline

• Maternal medication use

  Baseline

Study Arms (3)

tongue-tie

To evaluate the tongue and lingual frenulum, the TABBY assessment tool, which consists of 12 images demonstrating the appearance of the tongue tip, the insertion of the frenulum, and the mobility of the tongue (lift and protrusion), was used. It has a score between 0 and 8. Normal tongue function is represented by a score of 8; borderline values are represented by scores of 6 and 7; and impaired tongue function is indicated by scores of 5 and below. Newborns who scored five or below were included in the tongue-tie group.

upper lip-tie

The maxillary labial frenulum in the newborn was examined by lifting the upper lip and classified according to Kotlow. Newborns with a frenulum grade 3 (the frenulum inserts just in front of the anterior papilla) or grade 4 (the frenulum attaches just into the anterior papilla and extends into the hard palate) were included in the upper lip-tie group.

control

The control group comprised newborns without tongue-tie or upper lip-tie

Eligibility Criteria

• Age: 1 Hour - 48 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborns born within the last 48 hours

You may qualify if:

• Breastfed newborns born within the last 48 hours
• Gestational age of 38 weeks or more
• Uncomplicated delivery
• Absence of systemic problems, craniofacial anomalies, or birth defects.

You may not qualify if:

• Premature or low birth weight newborns
• Newborns with delivery complications
• Newborns admitted to the intensive care unit
• Any systemic problems, craniofacial anomalies, birth defects
• Presence of both tongue-tie and upper lip-tie
• Newborns exclusively formula-fed.

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (2)

Ayse Isil Orhan

Ankara, 06010, Turkey (Türkiye)

Location

Department of Pediatric Dentistry, Faculty of Dentistry, Ankara Yildirim Beyazit University,

Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ankyloglossia; lip tie; Breast Feeding

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Feeding Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: February 14, 2025
• Study Start: May 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)