NCT04703946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,167

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

3 years

First QC Date

January 8, 2021

Last Update Submit

May 7, 2021

Conditions

Ankyloglossia

Outcome Measures

Primary Outcomes (1)

  • Ankilloglosia

    presence or absence of Ankilloglosia

    2 weeks

Secondary Outcomes (1)

  • type of short frenulum

    2 weeks

Other Outcomes (6)

  • height

    2 weeks

  • weight

    2 weeks

  • cranial perimeter

    2 weeks

  • +3 more other outcomes

Interventions

observacionalOTHER

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.

Eligibility Criteria

Age1 Minute - 2 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

MeSH Terms

Conditions

Ankyloglossia

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jefe departamento de odontopedaitria

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 11, 2021

Study Start

January 1, 2018

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

May 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)