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

Completed

• Conditions: Randomized Controlled Trial; Growth and Development; Cicatrix; Cleft Lip and Palate

• Registration Number: NCT03395015
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Timeline

• Study Start: 2017-06-05
• Primary Completion: 2017-07-20
• Study Completion: 2017-12-22
• Status Verified: 2018-01
• Study First Submitted: 2018-01-03
• Study First Submitted QC: 2018-01-03
• Last Update Submitted: 2018-01-03
• Study First Posted: 2018-01-09
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intrarater and interrater consistency	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.

Trial Locations

Locations (1)

Catholic University of the Sacred Heart; 🇮🇹 Roma, Italia, Italy