Three-dimensional Cleft Lip and Palate Morphology Prior to One-stage Cleft Repair

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04616690
• Other study ID #: Warsaw/Basel
• Secondary ID: ch20Benitez
• Status: Completed
• Start date: December 7, 2020
• Est. completion date: March 8, 2024

Study information

• Verified date: March 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate
• Cleft Palate
• Craniofacial Deformity

Locations

Country	Name	City	State
Poland	Institute of Mother and Child	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Institute of Mother and Child, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

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