Tympanometric Analysis in Cleft Palate

March 26, 2013 updated by: Priscila de Araujo Lucas Rodrigues, Centro de Diagnostico Auditivo de Cuiaba

Tympanometric Analysis in Post Surgical Individuals With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • isolated cleft lip
  • associated syndromes
  • malformation of ear

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tympanometry measurement
Other: Tympanometry measurement
The tympanometry measurement will be verify and compared with the time of palatoplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months to 33 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Time of palatoplasty
Time Frame: 3 months to 33 years
3 months to 33 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro de Diagnostico Auditivo de Cuiaba

Collaborators

Federal University of Mato Grosso

Investigators

  • Principal Investigator: P A Rodrigues, Doctor, HUJM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

March 18, 2013

First Submitted That Met QC Criteria

March 26, 2013

First Posted (Estimate)

March 29, 2013

Study Record Updates

Last Update Posted (Estimate)

March 29, 2013

Last Update Submitted That Met QC Criteria

March 26, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUJM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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