Three-dimensional Cleft Lip and Palate Morphology Prior to One-stage Cleft Repair
NCT ID: NCT04616690
Last Updated: 2024-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2020-12-07
2024-03-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* no signed consent for research
6 Months
15 Months
ALL
No
Sponsors
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Institute of Mother and Child, Warsaw, Poland
OTHER
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Benito Benitez
Principal Investigator
Principal Investigators
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Benito K Benitez, MD DMD
Role: PRINCIPAL_INVESTIGATOR
University and University Hospital of Basel
Andrzej Brudnicki, MD DDS PhD
Role: PRINCIPAL_INVESTIGATOR
Maxillo-facial Surgery Unit, Pediatric Surgery Clinic, Institute of Mother and Child
Locations
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Institute of Mother and Child
Warsaw, , Poland
Countries
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References
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Doray B, Badila-Timbolschi D, Schaefer E, Fattori D, Monga B, Dott B, Favre R, Kohler M, Nisand I, Viville B, Kauffmann I, Bruant-Rodier C, Grollemund B, Rinkenbach R, Astruc D, Gasser B, Lindner V, Marcellin L, Flori E, Girard-Lemaire F, Dollfus H. [Epidemiology of orofacial clefts (1995-2006) in France (Congenital Malformations of Alsace Registry)]. Arch Pediatr. 2012 Oct;19(10):1021-9. doi: 10.1016/j.arcped.2012.07.002. Epub 2012 Aug 24. French.
Wang W, Jiang B, Sun H, Ru X, Sun D, Wang L, Wang L, Jiang Y, Li Y, Wang Y, Chen Z, Wu S, Zhang Y, Wang D, Wang Y, Feigin VL; NESS-China Investigators. Prevalence, Incidence, and Mortality of Stroke in China: Results from a Nationwide Population-Based Survey of 480 687 Adults. Circulation. 2017 Feb 21;135(8):759-771. doi: 10.1161/CIRCULATIONAHA.116.025250. Epub 2017 Jan 4.
Genisca AE, Frias JL, Broussard CS, Honein MA, Lammer EJ, Moore CA, Shaw GM, Murray JC, Yang W, Rasmussen SA; National Birth Defects Prevention Study. Orofacial clefts in the National Birth Defects Prevention Study, 1997-2004. Am J Med Genet A. 2009 Jun;149A(6):1149-58. doi: 10.1002/ajmg.a.32854.
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.
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.
Honigmann K. One-stage closure of uni- and bilateral cleft lip and palate. Br J Oral Maxillofac Surg. 1996 Jun;34(3):214-9. doi: 10.1016/s0266-4356(96)90272-7.
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.
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.
Brudnicki A, Piwowar W, Cudzilo D, Sawicka E. Complete unilateral cleft lip and palate operated on by means of the one-stage method - own experience. Dev Period Med. 2014;18(1):38-43.
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.
Kozelj V. The basis for presurgical orthopedic treatment of infants with unilateral complete cleft lip and palate. Cleft Palate Craniofac J. 2000 Jan;37(1):26-32. doi: 10.1597/1545-1569_2000_037_0026_tbfpot_2.3.co_2.
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.
Other Identifiers
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ch20Benitez
Identifier Type: OTHER
Identifier Source: secondary_id
Warsaw/Basel
Identifier Type: -
Identifier Source: org_study_id
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