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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT03395015

0027003/17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 20 to 25 years old

Volunteers: No Healthy Volunteers

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)

Trial design

10 participants in 2 patient groups

Full-face 3-D images

Description:

3-D images acquisition of CLP patients' faces at rest is set at different timepoints: 1 week preoperative, 1- and 6-months postoperative. Therefore, laypeople's assessment of the facial appearance of CLP patients is based on full facial views.

Treatment:

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

Nasolabial 3-D images

Description:

The control group is composed of cropped 3-D images of CLP patients' faces at rest, which show isolated nasolabial regions of CLP patients. The judgement of these pictures warrants an assessment based solely on the nasolabial appearance.

Treatment:

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