The Scandcleft project

Not Applicable

• Conditions: Complete unilateral cleft lip and palate; Genetic Diseases

• Registration Number: ISRCTN29932826
• Lead Sponsor: niversity of Manchester

Brief Summary

2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28218555 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28218553 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28218556 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28218557 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28218552 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28218554 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28218558 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28218561 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28218559 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28218551 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27778528 results 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/33367600/ analysis of baseline morphology (added 29/12/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34476476/ comparison of dental arch relationships and dental indices at 5, 8, and 10 years (added 06/09/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-02
• Last Update Posted: 20 September 2021
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 429

Inclusion Criteria

Caucasian patients born with non-syndromic unilateral complete cleft lip and palate. Patients with a soft tissue bridge (Simonart`s band) could be included as long as the width of the soft tissue bridge was not more than 5mm. The prevailing language of the country where recruited had to be spoken at home.

Exclusion Criteria

1. Non-caucasian
2. Wide Simonart band
3. Prevailing local language not spoken at home

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Speech and language at age 5 years, via blinded panel assessments using standardised audio/video recordings with regard to consonant proficiency and ratings of velopharyngeal competency and hypernasality<br> 2. Dentofacial development at 5 years, via blinded panel ratings of dentofacial relationship represented by articulated plaster casts of the dentition using the Five Year Yardstick and Huddart-Bodenham Index<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Perioperative complications recorded by medical and nursing staff<br> 2. Operation and hospitalisation time<br> 3. Postoperative recovery and feeding recorded by medical and nursing staff<br> 4. Speech at 12 and 18 months and 3 years<br> 5. Symptomatic fistulae<br> 6. Hearing<br> 7. Burden of care<br> 8. Parent satisfaction at age 5 years<br>