Cleft Palate Surgery and Speech Development

Velopharyngeal Function for Speech After Palatal Surgery

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004639

Enrollment

475

Registered

1999-09-20

Start date

1996-02-29

Completion date

2007-04-30

Last updated

2011-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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, Unilateral cleft lip and palate

Brief 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.

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.

Interventions

PROCEDUREFurlow double z-plasty palatoplasty palate repair

PROCEDUREVon Langenbeck palatoplasty palate repair

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	6 months

Countries

Brazil, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026