Cleft LipPhase 2NCT00004639
Cleft Palate Surgery and Speech Development
A Phase 2 study testing Furlow double z-plasty palatoplasty palate repair and Von Langenbeck palatoplasty palate repair in people with Cleft Lip and Cleft Palate, run by University of Florida at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cleft Lip, Cleft Palate
- What is being tested?
- Furlow double z-plasty palatoplasty palate repair and Von Langenbeck palatoplasty palate repair
- Type of treatment
- Surgery or procedure
- How many people
- 475 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 1996to Apr 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Brazil1 site
Hospital for Rehabilitation of Craniofacial Anomalies (USP-HRAC)
Bauru, São Paulo, 17043-900
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Cleft Lip, Cleft Palate
- Being tested
- Furlow double z-plasty palatoplasty palate repair, Von Langenbeck palatoplasty palate repair
- Keywords
- cleft lip and palate, children, speech, velopharyngeal function, congenital facial malformation, von Langenbeck procedure, Furlow procedure, cleft lip and palate repair, Unilateral cleft lip and palate
- Medical subject headings
- Cleft Lip, Cleft Palate, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furlow double z-plasty palatoplasty palate repairProcedure or surgery
Von Langenbeck palatoplasty palate repairProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 1999 (estimated)
- Study startFeb 1996
- Primary completionMar 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft LipStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Sponsor
- Investigators
- William N Williams, Ph.D, Principal investigator, Univerisity of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004639
- Sponsor's protocol ID
- NIDCR-010
- Other IDs
- R01DE010437
- Status last verified
- Jun 2011
- First submitted
- 17 Sep 1999
- Last updated
- 20 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Velopharyngeal Function for Speech After Palatal Surgery
- ClinicalTrials.gov ID
- NCT00004639
- Acronym / sponsor ID
- NIDCR-010
- Conditions
- Cleft Lip, Cleft Palate
- Keywords
- cleft lip and palate, children, speech, velopharyngeal function, congenital facial malformation, von Langenbeck procedure, Furlow procedure, cleft lip and palate repair
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Feb 1996
- Primary completion
- Mar 2006 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 20 Sep 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Furlow double z-plasty palatoplasty palate repair | Procedure or surgery | – |
| Von Langenbeck palatoplasty palate repair | Procedure or surgery | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2011.
Related trials for Cleft Lip
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
RecruitingPhase 2
Cleft Lip Scarring After Botox
Cleft Lip, Cleft Lip Scar
Not yet recruiting
Study on the Supportive Effect of Personalized Nostril Retainer in Unilateral Cleft Lip Surgery
Unilateral Cleft Lip
Not yet recruiting
Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
Cleft Lip Palate
Enrolling by invitationPhase 2
Evaluation of a Novel Nasal Conformer in Pediatric Patients
Cleft Lip, Nasal Surgical Procedures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William N Williams, Ph.D principal investigator
Univerisity of Florida
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Furlow double z-plasty palatoplasty palate repair and Von Langenbeck palatoplasty palate repair in people with Cleft Lip and Cleft Palate, run by University of Florida at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2011.