Efficacy of Maxillo-facial Treatment on Cleft Lip and Palate Patients Faces: Aesthetic Considerations

Cleft Lip and Palate Clinical Trial

Official title:

Efficacia Del Trattamento Chirurgico Maxillo-facciale Sul Volto Dei Bambini Con Labiopalatoschisi: Valutazioni Estetiche ed Ortodontiche

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03395015
• Other study ID #: 0027003/17
• Status: Completed
• Phase: N/A
• First received: January 3, 2018
• Last updated: January 3, 2018
• Start date: June 5, 2017
• Est. completion date: December 22, 2017

Study information

• Verified date: January 2018
• Source: Policlinico Universitario Agostino Gemelli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is to analyze the esthetic outcome of the first surgical repair of cleft lip and palate (CLP) patients.

The aim of the study is to identify differences in the aesthetic evaluation of full-face and nasolabial region 3-D images of CLP patients following primary lip repair by laypeople.

Description:

The management of cleft lip and palate patient's generally involves the soft palate reconstruction as well as the repair of lip and nasal soft tissue defects.

From an esthetic point of view, the primary repair, usually performed between 9 and 18 months of age, prepares the patients to grow into childhood and succeed in life without focusing on their deformity.

An increasing number of outcome measure rating systems has been raised, suggesting a lack of consensus to a reliable, validated and reproducible scoring system for facial aesthetics in cleft patients. Many templates and lay panel scoring systems have been described, yet never fully validated. Advanced 3D imaging technologies may produce validated outcome measures in the future, but presently there remains a need to develop a robust method of facial aesthetic evaluation based on standardised patient photographs.

The aim of the study is to to determine and compare the level of agreement among examiners' subjective aesthetic evaluation of full-face and nasolabial region 3-D images of CLP patients following primary lip repair by laypeople, developing some recommendations for a consistent scoring protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 22, 2017
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 25 Years

Eligibility

Inclusion Criteria:

• age, between 20 and 25 years

• sex, in order to have at least 25 male and female raters

• sociocultural status: the layperson panel includes undergraduate students without extensive professional knowledge on cleft lip and palate patients

Exclusion Criteria:

• previous participation in research studies

• familiarity or close friendship with cleft lip and palate patients

• lack of blindness about the study protocol (it could bias the reported results)

Related Conditions & MeSH terms

• Cicatrix
• Cleft Lip
• Cleft Lip and Palate
• Growth and Development
• Randomized Controlled Trial

Intervention

Other:
• VAS scale (from 1 to 10) esthetic assessment of facial 3-D images
The rating process is biphasic: firstly a 3-D model is showed to the raters, who can orientate the vultus, familiarize with the 3-D technology and have a first glance evaluation. Secondly, the judges are asked to rate each of the following patient views: right profile, left profile, frontal, neck hyperextension and hyperflexion views Two weeks after the first assessment, the same judges assessed the same number of pictures, once again in random order.

Locations

Country	Name	City	State
Italy	Catholic University of the Sacred Heart	Roma	Italia

Sponsors (11)

Lead Sponsor	Collaborator
Policlinico Universitario Agostino Gemelli	Dr. Bucci Daria, Dr. Candida Ettore, Dr. De Luca Marilisa, Dr. Oliva Giorgio, Dr. Rajabtork Zadeh Oriana, Dr. Rizzo Maria Ida, Dr. Romeo Patini, Dr. Zama Mario, Prof. Gallenzi Patrizia, Prof. Massimo Cordaro

Country where clinical trial is conducted

Italy, 

References & Publications (6)

de Ladeira PR, Alonso N. Protocols in cleft lip and palate treatment: systematic review. Plast Surg Int. 2012;2012:562892. doi: 10.1155/2012/562892. Epub 2012 Nov 1. — View Citation

Eichenberger M, Staudt CB, Pandis N, Gnoinski W, Eliades T. Facial attractiveness of patients with unilateral cleft lip and palate and of controls assessed by laypersons and professionals. Eur J Orthod. 2014 Jun;36(3):284-9. doi: 10.1093/ejo/cjt047. Epub — View Citation

Iliopoulos C, Mitsimponas K, Lazaridou D, Neukam FW, Stelzle F. A retrospective evaluation of the aesthetics of the nasolabial complex after unilateral cleft lip repair using the Tennison-Randall technique: a study of 44 cases treated in a single cleft ce — View Citation

Mosmuller DG, Bijnen CL, Kramer GJ, Disse MA, Prahl C, Kuik DJ, Niessen FB, Don Griot JP. The Asher-McDade Aesthetic Index in Comparison With Two Scoring Systems in Nonsyndromic Complete Unilateral Cleft Lip and Palate Patients. J Craniofac Surg. 2015 Jun — View Citation

Sharma VP, Bella H, Cadier MM, Pigott RW, Goodacre TE, Richard BM. Outcomes in facial aesthetics in cleft lip and palate surgery: a systematic review. J Plast Reconstr Aesthet Surg. 2012 Sep;65(9):1233-45. doi: 10.1016/j.bjps.2012.04.001. Epub 2012 May 15 — View Citation

Stebel A, Desmedt D, Bronkhorst E, Kuijpers MA, Fudalej PS. Rating nasolabial appearance on three-dimensional images in cleft lip and palate: a comparison with standard photographs. Eur J Orthod. 2016 Apr;38(2):197-201. doi: 10.1093/ejo/cjv024. Epub 2015 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrarater and interrater consistency	The primary outcome of this study is to compare intrarater and interrater reliability of the ratings in both groups.; The reliability of a panel of 3 and 6 judges for the different scoreswere estimated by using the Cronbach alfa formula.	3-D images are assessed twice, the timespan between the two evaluations is two weeks