Cleft Lip and Palate Clinical Trial
Official title:
Collaborative, Comparative Study on Three-dimensional Cleft Lip and Palate Morphology Prior to One-stage Cleft Repair (Warsaw/Basel)
Verified date | March 2024 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This is a prospective observational cohort study of consecutive patients with cleft lip and palate deformity undergoing cleft repair at the Institute of Mother and Child in Warsaw. Cleft morphology will be captured with photo and intraoral camera before routine surgery at around 8 months. Furthermore, wound healing at 3 months postoperative will be assessed.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 8, 2024 |
Est. primary completion date | May 17, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 15 Months |
Eligibility | Inclusion Criteria: - patients with orofacial cleft, who undergo routine cleft repair Exclusion Criteria: - missing datasets - no signed consent for research |
Country | Name | City | State |
---|---|---|---|
Poland | Institute of Mother and Child | Warsaw |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland | Institute of Mother and Child, Warsaw, Poland |
Poland,
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IPDTOC Working Group. Prevalence at birth of cleft lip with or without cleft palate: data from the International Perinatal Database of Typical Oral Clefts (IPDTOC). Cleft Palate Craniofac J. 2011 Jan;48(1):66-81. doi: 10.1597/09-217. Epub 2010 Apr 6. — View Citation
Kozelj V. Changes produced by presurgical orthopedic treatment before cheiloplasty in cleft lip and palate patients. Cleft Palate Craniofac J. 1999 Nov;36(6):515-21. doi: 10.1597/1545-1569_1999_036_0515_cpbpot_2.3.co_2. — View Citation
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Mueller AA, Zschokke I, Brand S, Hockenjos C, Zeilhofer HF, Schwenzer-Zimmerer K. One-stage cleft repair outcome at age 6- to 18-years -- a comparison to the Eurocleft study data. Br J Oral Maxillofac Surg. 2012 Dec;50(8):762-8. doi: 10.1016/j.bjoms.2012.02.002. Epub 2012 May 1. — View Citation
Nalabothu P, Benitez BK, Dalstra M, Verna C, Mueller AA. Three-Dimensional Morphological Changes of the True Cleft under Passive Presurgical Orthopaedics in Unilateral Cleft Lip and Palate: A Retrospective Cohort Study. J Clin Med. 2020 Mar 31;9(4):962. doi: 10.3390/jcm9040962. — View Citation
Shaw WC, Semb G, Nelson P, Brattstrom V, Molsted K, Prahl-Andersen B, Gundlach KK. The Eurocleft project 1996-2000: overview. J Craniomaxillofac Surg. 2001 Jun;29(3):131-40; discussion 141-2. doi: 10.1054/jcms.2001.0217. — View Citation
Urbanova W, Klimova I, Brudnicki A, Polackova P, Kroupova D, Dubovska I, Rachwalski M, Fudalej PS. The Slav-cleft: A three-center study of the outcome of treatment of cleft lip and palate. Part 1: Craniofacial morphology. J Craniomaxillofac Surg. 2016 Nov;44(11):1767-1776. doi: 10.1016/j.jcms.2016.06.010. Epub 2016 Jun 17. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | True Cleft Area in mm2 of Newborns With Cleft Lip and Palate at 8 Month of Age | True cleft area in mm2 will be measured at 8 month of age in newborns with cleft lip and palate. | Capture of the cleft morphology with photo and intraoral camera before routine surgery at around 8 months. | |
Secondary | Cleft Width and Height in mm of Newborns With Cleft Lip and Palate at 8 Month of Age | Measurement of the width and height in mm of the cleft measured at 8 months of age. | Capture of the cleft morphology with photo and intraoral camera before routine surgery at around 8 months. | |
Secondary | Wound Healing (fistula yes or no) 3 Months After One-Stage Cleft Repair | Assessment of wound healing by fistula formation at 3 months postoperative | At 3 months postoperative | |
Secondary | Correlation of Cleft Width in mm and Wound Healing after One-Stage Cleft Repair | Evaluation of the correlation between cleft width in mm and wound healing | At surgery and at 3 months postoperative |
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