Skip to main content
OpenTrials
Completed

NCT Number: NCT03395015

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

VAS scale (from 1 to 10) esthetic assessment of facial 3-D images

Other

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.

Primary outcomes

  1. Intrarater and interrater consistency

    Time frame: 3-D images are assessed twice, the timespan between the two evaluations is two weeks

    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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 9, 2018
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.