AzTrials
AzTrials

Cleft Lip and PalateNCT04616690

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

An observational study of Cleft Lip and Palate and Cleft Palate, run by University Hospital, Basel, Switzerland at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 6 to 15 months
How many people
40 participants
Where
1 sitePoland
Study dates
7 Dec 2020to 8 Mar 2024
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 15 months
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • patients with orofacial cleft, who undergo routine cleft repair

Who cannot join

  • missing datasets
  • no signed consent for research

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Institute of Mother and Child

    Warsaw, 01-211

Other trials in Poland

About this study

Official title: Collaborative, Comparative Study on Three-dimensional Cleft Lip and Palate Morphology Prior to One-stage Cleft Repair (Warsaw/Basel)

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.

Keywords
Cleft Lip and Palate, Presurgical Orthopedics, Cleft Morphology, Palatal Plate
Medical subject headings
Cleft Lip, Cleft Palate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

  1. 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.

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

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

    Assessment of wound healing by fistula formation at 3 months postoperative

    Measured: At 3 months postoperative

  3. 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

    Measured: At surgery and at 3 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2020
  2. Study start7 Dec 2020
  3. Primary completion17 May 2022
  4. Study completion8 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04616690
Sponsor's protocol ID
Warsaw/Basel
Other IDs
ch20Benitez
Status last verified
Mar 2024
First submitted
25 Oct 2020
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 22925539

  • 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.

    PubMed 28052979

  • 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.

    PubMed 19441124

  • 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.

    PubMed 20507242

  • 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.

    PubMed 11465251

  • 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.

    PubMed 8818253

  • 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.

    PubMed 22551772

  • 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.

    PubMed 27663676

  • 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.

    PubMed 25171619

  • 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.

    PubMed 10574670

  • 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.

    PubMed 10670886

  • 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.

    PubMed 32244361

Questions about this trial

What is this clinical trial studying?

An observational study of Cleft Lip and Palate and Cleft Palate, run by University Hospital, Basel, Switzerland at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

True Cleft Area in mm2 of Newborns With Cleft Lip and Palate at 8 Month of Age (time frame: Capture of the cleft morphology with photo and intraoral camera before routine surgery at around 8 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04616690, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in