Bilateral Complete Cleft Lip and/or Alveolus Clinical Trial
Official title:
Tympanometric Analysis in Post Surgical Individuals With Cleft Palate
| Verified date | March 2013 |
| Source | Centro de Diagnostico Auditivo de Cuiaba |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Brazil: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | November 2012 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Year and older |
| Eligibility |
Inclusion Criteria: - cleft incisive trans unilateral or bilateral - post-foramen complete or incomplete Exclusion Criteria: - isolated cleft lip - associated syndromes - malformation of ear |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Centro de Diagnostico Auditivo de Cuiaba | Federal University of Mato Grosso do Sul |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Tympanic membrane mobility | Tympanic membrane mobility will be measured through the tympanometry and will be demonstrated through their complacency in ml. | 3 months to 33 years | Yes |
| Secondary | Time of palatoplasty | 3 months to 33 years | Yes |