Back to resultsTympanometric Analysis in Cleft Palate
Primary Purpose
Bilateral Complete Cleft Lip and/or Alveolus
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tympanometry measurement
Sponsored by
About this trial
This is an interventional diagnostic trial for Bilateral Complete Cleft Lip and/or Alveolus
Eligibility Criteria
Inclusion Criteria:
- cleft incisive trans unilateral or bilateral
- post-foramen complete or incomplete
Exclusion Criteria:
- isolated cleft lip
- associated syndromes
- malformation of ear
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tympanometry measurement
Arm Description
Outcomes
Primary Outcome Measures
Tympanic membrane mobility
Tympanic membrane mobility will be measured through the tympanometry and will be demonstrated through their complacency in ml.
Secondary Outcome Measures
Time of palatoplasty
Full Information
NCT ID
NCT01820689
First Posted
March 18, 2013
Last Updated
March 26, 2013
Sponsor
Centro de Diagnostico Auditivo de Cuiaba
Collaborators
Federal University of Mato Grosso
1. Study Identification
Unique Protocol Identification Number
NCT01820689
Brief Title
Tympanometric Analysis in Cleft Palate
Official Title
Tympanometric Analysis in Post Surgical Individuals With Cleft Palate
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro de Diagnostico Auditivo de Cuiaba
Collaborators
Federal University of Mato Grosso
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Complete Cleft Lip and/or Alveolus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tympanometry measurement
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Tympanometry measurement
Intervention Description
The tympanometry measurement will be verify and compared with the time of palatoplasty.
Primary Outcome Measure Information:
Title
Tympanic membrane mobility
Description
Tympanic membrane mobility will be measured through the tympanometry and will be demonstrated through their complacency in ml.
Time Frame
3 months to 33 years
Secondary Outcome Measure Information:
Title
Time of palatoplasty
Time Frame
3 months to 33 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
cleft incisive trans unilateral or bilateral
post-foramen complete or incomplete
Exclusion Criteria:
isolated cleft lip
associated syndromes
malformation of ear
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P A Rodrigues, Doctor
Organizational Affiliation
HUJM
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Tympanometric Analysis in Cleft Palate
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