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

NCT04616690 | Completed

• 2 other identifiers: Warsaw/Baselch20Benitez
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cleft Lip and Palate; Cleft Palate; Craniofacial Deformity

Keywords

Cleft Lip and Palate; Presurgical Orthopedics; Cleft Morphology; Palatal Plate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Cleft Width and Height in mm of Newborns With Cleft Lip and Palate at 8 Month of Age

  Capture of the cleft morphology with photo and intraoral camera before routine surgery at around 8 months.

• Wound Healing (fistula yes or no) 3 Months After One-Stage Cleft Repair

  At 3 months postoperative

• Correlation of Cleft Width in mm and Wound Healing after One-Stage Cleft Repair

  At surgery and at 3 months postoperative

Eligibility Criteria

• Age: 6 Months - 15 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for this study must have an orofacial cleft which has to be treated around the age of 6-15 months.

You may qualify if:

• patients with orofacial cleft, who undergo routine cleft repair

You may not qualify if:

• missing datasets
• no signed consent for research

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Institute of Mother and Child, Warsaw, Poland: collaborator

Study Sites (1)

Institute of Mother and Child

Warsaw, 01-211, Poland

Location

Related Publications (12)

• 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.

  PMID: 22925539 BACKGROUND

• 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.

  PMID: 28052979 BACKGROUND

• 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.

  PMID: 19441124 BACKGROUND

• 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.

  PMID: 20507242 BACKGROUND

• 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.

  PMID: 11465251 BACKGROUND

• 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.

  PMID: 8818253 BACKGROUND

• 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.

  PMID: 22551772 BACKGROUND

• 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.

  PMID: 27663676 BACKGROUND

• 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.

  PMID: 25171619 BACKGROUND

• 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.

  PMID: 10574670 BACKGROUND

• 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.

  PMID: 10670886 BACKGROUND

• 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.

  PMID: 32244361 BACKGROUND

MeSH Terms

Conditions

Cleft Lip; Cleft Palate

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities

Study Officials

• Benito K Benitez, MD DMD

  University and University Hospital of Basel

  PRINCIPAL INVESTIGATOR

• Andrzej Brudnicki, MD DDS PhD

  Maxillo-facial Surgery Unit, Pediatric Surgery Clinic, Institute of Mother and Child

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2020
• First Posted: November 5, 2020
• Study Start: December 7, 2020
• Primary Completion: May 17, 2022
• Study Completion: March 8, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

PL (1)