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CompletedNCT04703946Updated May 11, 2021

Incidence of Short Sublingual Frenulum in Newborns at the Hospital Nostra Senyora de Meritxell.

An observational study in Ankyloglossia, sponsored by Universitat Internacional de Catalunya. Completed at 1 site in Spain. Open to participants aged 1 Minute to 2 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-11.

Sponsored by Universitat Internacional de Catalunya · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
2,167
Ages
1 Minute to 2 Weeks
Sex
All
01

Study summary

The aim of the study was to analyze the incidence of short sublingual frenulum in newborns of the Hospital Nostra Senyora de Meritxell of the Principat of Andorra.

Read the detailed description

Thus, the objective of this study was to determine the incidence of AG in newborns of the Hospital Nostra Senyora de Meritxell of the Principat of Andorra, as well as the relationship with auxological data, associated malformations or diseases and hereditary component of the newborn.

A random sample of 2167 individuals is enough to estimate, with a confidence of 95% and an accuracy of +/- 1 percentage units, a population percentage that is projected to be around 6%. The percentage of replenishment required is projected to be 0%. With this sample, it will be sufficient to estimate the children who have ankyloglossia, the % of relatives who also have it (a population percentage that is projected to be around 25%). Confidential and anonymous collection of data from patients' medical records for a period of 2 years and 8 months, and write them down in a database to finally correlate them and see if there is any association with the parameters studied.

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Conditions studied

  • Ankyloglossia

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03

In context

Ankyloglossia

32 studies on the registry are indexed under Ankyloglossia; 8 are open to participants now.

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Lead sponsor

Universitat Internacional de Catalunya is the lead sponsor of 151 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Minute to 2 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

A random sample of 2167 individuals is enough to estimate, with a confidence of 95% and an accuracy of +/- 1 percentage units, a population percentage that is projected to be around 6%. The percentage of replenishment required is projected to be 0%.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The inclusion criteria are patients born from July 2018 to February 2021 (both inclusive) and of both genders.

Exclusion criteria

Exclusion Criteria:

  • The exclusion criteria are all those who were born abroad and who after 24 hours go to the Hospital of Andorra, those urgently transferred to other foreign centers after birth, as well as those who present medical records with lack of information.
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
2,167 participants (actual)
Patient registry
No

Interventions

  • Otherobservacional

    Analyze the incidence of short sublingual frenulum in newborns of the Hospital Nostra Senyora de Meritxell of the Principat of Andorra. 1. Association or not of the AG with auxological parameters (weight, height, cranial perimeter) at birth. 2. Association or not of the AG with sex. 3. Association or not of the AG with gestational age. 4. Association or not of the AG with other minor and major malformations.

06

What researchers measure

Primary outcomes

  1. Ankilloglosia

    presence or absence of Ankilloglosia

    Time frame: 2 weeks

Secondary outcomes

  1. type of short frenulum

    One of the anatomical classification of the lingual frenulum is that of Coryllos, which classifies the lingual frenulum depending on its proximity to the lingual apex, based on 4 types

    Time frame: 2 weeks

Other outcomes

  1. height

    height

    Time frame: 2 weeks

  2. weight

    weight

    Time frame: 2 weeks

  3. cranial perimeter

    cranial perimeter

    Time frame: 2 weeks

  4. sex

    sex

    Time frame: 2 weeks

  5. type of lactation

    type of lactation

    Time frame: 2 weeks

  6. hereditary factor (if the parents presented/present or not AG)

    hereditary factor (if the parents presented/present or not AG)

    Time frame: 2 weeks

07

Study locations

1 site
  • Universitat Internacional de Catalunya
    Sant Cugat del Vallès, Barcelona 08195, Spain
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04703946
Responsible party
Francisco Guinot-Jimeno (Jefe departamento de odontopedaitria, Universitat Internacional de Catalunya) — Principal investigator
First posted
Jan 11, 2021
Start date
Jan 1, 2018
Primary completion
Dec 30, 2020
Completion
Dec 30, 2020
Last update
May 11, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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