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Tongue-tieNCT06826482

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

An observational study of Tongue-tie and Upper Lip-tie, run by Ankara Yildirim Beyazıt University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 hour to 48 hoursHealthy volunteers can take part
Conditions the study is for
Tongue-tie, Upper Lip-tie
How many people
67 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 May 2022to 1 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 hour to 48 hours
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Newborns born within the last 48 hours

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Ayse Isil Orhan

    Ankara, 06010

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

    Ankara, 06010

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effects of Tongue-Tie and Upper Lip-Tie on Breastfeeding With Ultrasound Measurements and the LATCH Breastfeeding Assessment Tool

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.

Read the detailed description
  1. Sample characteristics and study design: This prospective cohort study was conducted at Ankara Yıldırım Beyazit University Faculty of Medicine, Internal Medicine Sciences, Department of Child Health and Diseases, Neonatology Clinic, from May 2022 to December 2022. The study included newborns with tongue-tie, newborns with upper lip-tie, and newborns without both. Written informed consent was obtained from all participating mothers, and the study was approved by the Clinical Research Ethics Committee of Ankara Yıldırım Beyazit University Faculty of Medicine (date and number: 30.03.2022 /26379996/06). The inclusion criteria were breastfed newborns born within the last 48 hours, with a gestational age of 38 weeks or more, uncomplicated delivery, and no systemic problems, craniofacial anomalies, or birth defects. The exclusion criteria included premature or low birth weight newborns; those with delivery complications; intensive care unit admissions; systemic problems; craniofacial anomalies; birth defects; both tongue-tie and upper lip-tie; and those exclusively formula-fed. As there was no comparable study that could be consulted to determine the sample size in the literature, a total of 60 neonates were recruited, with 20 in each group: tongue-tie (group 1), upper lip-tie (group 2), and control (group 3).
  2. Data collection: Data on maternal age, medical conditions, pregnancy medication, consanguineous marriage, number of births, breastfeeding experience, and breastfeeding education were collected via face-to-face interviews. Gestational week, sex, birth weight and mode of delivery were obtained from the birth records. The baby's tongue movements while crying were observed for lingual frenulum examination. 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 in this study. The maxillary labial frenulum in the newborn was examined by lifting the upper lip and classified according to Kotlow [4]. 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. In addition, when the upper lip was lifted upward, whether the upper lip touched the newborn's nose and whether whitening occurred in the area where the frenulum adhered to the alveolar crest were noted. The control group comprised newborns without tongue-tie or upper lip-tie. Ultrasound imaging was conducted between the 5th and 15th days after birth by a single dentomaxillofacial radiologist with 14 years of experience. To evaluate the infants' sucking abilities, the mother was seated in a comfortable chair in the correct posture for breastfeeding. A GE Medical System Verasana Active (Wuxi, Jiangsu, China) mobile ultrasonography device equipped with a 6-10 MHz 8C-RS microconvex probe was used to capture 2D real-time, B-mode, and M-mode images of the oral cavity of the neonates. Imaging was performed through a submental approach via ultrasonic gel (Aquasonic, Parker Labs., Fairfield, NJ, USA). The data collection commenced when the infant began to latch onto the breast and concluded when the feeding ended. The study excluded recordings that exhibited artifacts resulting from movements of the mother-newborn pair or the operator, as well as recordings in which the presence of nutritive sucking could not be observed. All measurements were conducted on recorded ultrasonography images. Before starting the measurement in the study, the observer was calibrated to recognize and identify the neonate maxillofacial and oral anatomy; for this purpose, 10 different neonate ultrasonography images other than those used in the study were used. The observer was blinded to any patient data. During sucking, ultrasound imaging of the tongue, hyoid bone, nipple, and hard and soft palates was performed in the midsagittal plane. A suck cycle was defined as beginning when the mid-tongue was in apposition with the palate (tongue up), followed by a downward excursion of the tongue until the mid-tongue reached its lowest point (tongue down) and then reunited with the palate. During sucking, while the tongue is positioned both upward and downward, the distance between the nipple (N) and the hard-soft palate junction (HSPJ), the depth of the intraoral space (the distance from the HSPJ to the surface of the mid-tongue), the nipple diameter (ND) measured at intervals of 2, 5, 10, and 15 mm from the tip of the nipple, and the anterior and mid-tongue heights (the distance between the dorsal surface of the anterior and mid-tongues and the inferior border of the genioglossus muscle) were assessed via ultrasound imaging. Breastfeeding was assessed via the LATCH tool during ultrasound imaging. 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. To evaluate nipple pain, the mother was asked to rate her pain during breastfeeding on a numerical scale. A score of 0 indicated "absence of pain," and a score of 10 indicated "presence of unbearable pain". Newborns' feeding practices (exclusive or nonexclusive breastfeeding) were also noted. Mothers were interviewed by telephone at the 1st month after birth and asked questions about infant feeding practices, maternal nipple pain, and whether any intervention was made for newborns with tongue-tie and upper lip-tie.
  3. Statistical analysis:

The data were analyzed via IBM SPSS Statistics 22.0 (IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY: IBM Corp) Nonnormally distributed data were compared via the Mann-Whitney U test for paired groups and the Kruskall-Wallis H test for three or more groups. Descriptive statistics, chi-square test and correlation analyses were conducted. A value of p<0.05 was considered statistically significant.

Keywords
Tongue-tie, upper lip-tie, breastfeeding, ultrasonography, newborn
Medical subject headings
Ankyloglossia, lip tie, Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06826482
Study groupRoleWhat they receive
tongue-tieTo 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-tieThe 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.
controlThe control group comprised newborns without tongue-tie or upper lip-tie

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Between the 5th and 15th days after birth.

  2. 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.

    Measured: Between the 5th and 15th days after birth.

  3. 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.

    Measured: Between the 5th and 15th days after birth.

  4. 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.

    Measured: Between the 5th and 15th days after birth.

  5. 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.

    Measured: Between the 5th and 15th days after birth.

  6. 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.

    Measured: Between the 5th and 15th days after birth.

  7. 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.

    Measured: Between the 5th and 15th days after birth.

  8. 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.

    Measured: Between the 5th and 15th days after birth.

  9. 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.

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

  10. 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".

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2025
  2. Study start1 May 2022
  3. Primary completion1 Dec 2022
  4. Study completion1 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06826482
Sponsor's protocol ID
26379996/06
Status last verified
Feb 2025
First submitted
1 Feb 2025
Last updated
14 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Tongue-tie and Upper Lip-tie, run by Ankara Yildirim Beyazıt University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distance between the nipple (N) and the hard-soft palate junction (time frame: Between the 5th and 15th days after birth.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.

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