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

Completed

• Conditions: Ankyloglossia

• Registration Number: NCT04703946
• Lead Sponsor: Universitat Internacional de Catalunya

Brief 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.

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-11
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2167

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ankilloglosia	2 weeks	presence or absence of Ankilloglosia

Secondary Outcome Measures

Name	Time	Method
type of short frenulum	2 weeks	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

Trial Locations

Locations (1)

Universitat Internacional de Catalunya; 🇪🇸 Sant Cugat del Vallès, Barcelona, Spain