Tympanometric Analysis in Cleft Palate

Not Applicable

Completed

• Conditions: Bilateral Complete Cleft Lip and/or Alveolus
• Interventions: Other: Tympanometry measurement

• Registration Number: NCT01820689
• Lead Sponsor: Centro de Diagnostico Auditivo de Cuiaba

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-09
• Study Completion: 2012-11
• Status Verified: 2013-03
• Study First Submitted: 2013-03-18
• Study First Submitted QC: 2013-03-26
• Last Update Submitted: 2013-03-26
• Study First Posted: 2013-03-29
• Last Update Posted: 2013-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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

Exclusion Criteria

• isolated cleft lip
• associated syndromes
• malformation of ear

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tympanometry measurement	Tympanometry measurement	-

Primary Outcome Measures

Name	Time	Method
Tympanic membrane mobility	3 months to 33 years	Tympanic membrane mobility will be measured through the tympanometry and will be demonstrated through their complacency in ml.

Secondary Outcome Measures

Name	Time	Method
Time of palatoplasty	3 months to 33 years