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OpenTrials
Completed

NCT Number: NCT01820689

Tympanometric Analysis in Cleft Palate

Purpose: Characterize the profile of tympanometric patients with cleft lip and palate in the post surgery period and correlate it with the time of palatoplasty. Methods: The sample consisted of 16 patients with cleft lip or palate totaling 32 ears treated at a Public University Hospital in Cuiabá (MT)- Brazil, in the post surgery moment that varied from three months to 33 years. Were sampled patients of both sexes, pediatrics and adults.

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Key information

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • cleft incisive trans unilateral or bilateral
  • post-foramen complete or incomplete

Exclusion criteria

  • isolated cleft lip
  • associated syndromes
  • malformation of ear

Treatment and study plan

Tympanometry measurement

Other

The tympanometry measurement will be verify and compared with the time of palatoplasty.

Primary outcomes

  1. Tympanic membrane mobility

    Time frame: 3 months to 33 years

    Tympanic membrane mobility will be measured through the tympanometry and will be demonstrated through their complacency in ml.

Secondary outcomes

  1. Time of palatoplasty

    Time frame: 3 months to 33 years

Sponsors and collaborators

Lead sponsor

Centro de Diagnostico Auditivo de Cuiaba

Other

Collaborators

  • Federal University of Mato Grosso

Registry information

Official study title

Tympanometric Analysis in Post Surgical Individuals With Cleft Palate

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 29, 2013
Registry last updated
Mar 29, 2013

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

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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.