| September 17, 1999 |
| July 17, 2008 |
| February 1996 |
| March 2006 (final data collection date for primary outcome measure) |
| Velopharyngeal function for speech was identified to be better for patients who received the Furlow double opposing z-palatoplasty procedure than patients who received the von Langenbeck procedure, as determined by the Cul-de-Sac Test of Hypernasality. [ Time Frame: 6 months ] [ Designated as safety issue: No ] |
| Velopharyngeal function for speech was identified to be better for patients who received the Furlow double opposing z-palatoplasty procedure than patients who received the von Langenbeck procedure, as determined by the Cul-de-Sac Test of Hypernasality. |
| Complete list of historical versions of study NCT00004639 on ClinicalTrials.gov Archive Site |
| |
| |
| |
| Cleft Palate Surgery and Speech Development |
| Velopharyngeal Function for Speech After Palatal Surgery |
Compare the outcome of two primary surgeries techniques (von Langenbeck and Furlow double z-plasty) performed on children with cleft lip/palate to determine if one results in significantly better velopharyngeal competency for speech. |
This study is conducted with patients with complete unilateral cleft lip and palate. The subjects will have their palatal clefts surgically repaired by either the von Langenbeck or the Furlow double z-plasty palatoplasty. Patients will be randomly assigned to four groups, to have with the von Langenbeck palatoplasty with intravelar veloplasty or the Furlow double opposing z-plasty palatoplasty between 9 and 12 months of age or between 15 and 18 months of age. Lip repair will be randomized to either the Spina or Millard method and will be accomplished by six months prior to palatoplasty. The major emphasis will focus on assessment of the near and long term outcomes of the palatal surgeries on velopharyngeal function for speech. |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
|
|
- Procedure: Furlow double z-plasty palatoplasty palate repair
- Procedure: Von Langenbeck palatoplasty palate repair
|
| |
| |
| |
| Completed |
| 475 |
| April 2007 |
| March 2006 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Unrepaired unilateral cleft lip and palate
- Lip repair surgery to be accomplished by 3-6 months of age
- Able to return to research site at least once a year for follow-up
Exclusion Criteria:
- Patients with concomitant conditions (ie. mental retardation, deafness)
- Patients with Simonart Band of the cleft
- Patients who could not return to research site on a yearly basis
|
| Both |
|
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Brazil |
| |
| NCT00004639 |
| Dr. William N. Williams, Ph.D., University of Florida |
| NIDCR-010, R01DE10437 |
| National Institute of Dental and Craniofacial Research (NIDCR) |
| University of Sao Paulo |
| Principal Investigator: |
William N Williams, Ph.D |
Univerisity of Florida |
|
|
| National Institute of Dental and Craniofacial Research (NIDCR) |
| July 2008 |
