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

NCT ID: NCT04703946

Last Updated: 2021-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2167 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-12-30

Brief Summary

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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

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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.

Conditions

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Ankyloglossia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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observacional

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:

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

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.
Minimum Eligible Age

1 Minute

Maximum Eligible Age

2 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitat Internacional de Catalunya

OTHER

Sponsor Role lead

Responsible Party

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Francisco Guinot-Jimeno

Jefe departamento de odontopedaitria

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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UIC-ODP-ANDORRA

Identifier Type: -

Identifier Source: org_study_id

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