Clinical trial NCT03395015: Efficacy of Maxillo-facial Treatment on Cleft Lip and Palate Patients Faces: Aesthetic Considerations
Official title: Efficacia Del Trattamento Chirurgico Maxillo-facciale Sul Volto Dei Bambini Con Labiopalatoschisi: Valutazioni Estetiche ed Ortodontiche
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cleft Lip and Palate
Growth and Development
Cicatrix
Randomized Controlled Trial
Keywords: Reconstructive surgical procedures
Therapy, soft tissue
Treatment outcome
Outcome Assessment (Health Care)
Photogrammetry
Physical Appearance, Body
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Prof. Massimo Cordaro
name: Dr. Romeo Patini
name: Dr. Oliva Giorgio
name: Dr. Candida Ettore
name: Dr. De Luca Marilisa
name: Dr. Rizzo Maria Ida
name: Dr. Zama Mario
name: Dr. Rajabtork Zadeh Oriana
name: Dr. Bucci Daria
name: Prof. Gallenzi Patrizia
First posted: 2018-01-09
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The lay panel consisted of 50 undergraduate students who had little or no training in cleft palate or cranio-facial treatment. All panelists were recruited from the Catholic University of Sacred Heart. The participation of the study is voluntary. A preliminary assessment of raters' knowledge has been performed through an oral examination.

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Intrarater and interrater consistency
timeFrame: 3-D images are assessed twice, the timespan between the two evaluations is two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Catholic University of the Sacred Heart
state: Italia
Study officials:
affiliation: Catholic University of the Sacred Hearth - Rome
name: Massimo Cordaro, Medicine
role: PRINCIPAL_INVESTIGATOR
References:
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 center. J Craniomaxillofac Surg. 2014 Dec;42(8):1679-83. doi: 10.1016/j.jcms.2014.05.013. Epub 2014 May 24.
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 2013 Jul 5.
citation: 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.
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.
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 Apr 21.
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;26(4):1242-5. doi: 10.1097/SCS.0000000000001784.