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Completed

NCT Number: NCT03708406

Otologic and Rhinologic Outcomes in Children With Clef Palate

OBJECTIVE:

To compare otologic and rhinologic outcomes in patients with cleft palate according to surgical protocols and type of cleft.

DESIGN:

Monocentric retrospective and prospective analysis of medical reports.

PATIENTS, PARTICIPANTS:

All consecutively treated patients affected by a cleft palate, born between December 2006 and December 2009 and followed in the Montpellier University Hospital, at the age of 10 years.

INTERVENTIONS:

Results of audiometry, tympanometry, otoscopy, tubomanometry and rhinomanometry and orofacial tomodensitometry done at the age of 10 were evaluated.

MAIN OUTCOME MEASURE(S):

The history of ventilation tubes inserted, and the results at the EDTQ test were analyzed.

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Key information

Conditions

Cleft Lip and Palate Cleft Lip Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Lip Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

9 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 10 yo children with operated clefts followed in the universitary hospital of Montpellier
  • who went to the ENT check up

Exclusion criteria

  • Thoses who skip the check up

Treatment and study plan

Primary outcomes

  1. Audiometry

    Time frame: 1 day

    evaluation of the hearing threshold

Secondary outcomes

  1. nasal ventilation

    Time frame: 1 day

    Nasal ventilation will be assessed with passive anterior rhinomanometry

  2. Eustachian tube function

    Time frame: 1 day

    Eustachian tube function will be assessed with tubomanometry

  3. Facial 3D scan

    Time frame: 1 day

    Facial 3D scan will be used to measure 2 criteria :

    • Total volum of the mastoid
    • Total volum of the mastoid's cells (pneumatization)

    Facial 3D scan will be used to measure 2 criteria :

    • Total volum of the mastoid
    • Total volum of the mastoid's cells (pneumatization)

    Facial 3D scan will be used to measure 2 criteria :

    • Total volum of the mastoid
    • Total volum of the mastoid's cells (pneumatization)

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Otologic and Rhinologic Outcomes in Children With Cleft Palate at Age 10 Years

Acronym: Clef Palate

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 17, 2018
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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