NCT03395015

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

2 months

First QC Date

January 3, 2018

Last Update Submit

January 3, 2018

Conditions

Cleft Lip and PalateGrowth and DevelopmentCicatrixRandomized Controlled Trial

Keywords

Reconstructive surgical proceduresTherapy, soft tissueTreatment outcomeOutcome Assessment (Health Care)PhotogrammetryPhysical Appearance, Body

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Full-face 3-D images

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.

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

Nasolabial 3-D images

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.

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

Interventions

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

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.

Full-face 3-D imagesNasolabial 3-D images

Eligibility Criteria

Age20 Years - 25 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsThe raters selection is aiming to have an equal number of male and female judges.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of the Sacred Heart

Roma, Italia, 00168, Italy

Location

Related Publications (6)

  • 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.

    PMID: 24962045RESULT

  • 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.

    PMID: 23832974RESULT

  • 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.

    PMID: 23213503RESULT

  • 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.

    PMID: 22591614RESULT

  • 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.

    PMID: 25900054RESULT

  • 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.

    PMID: 26080166RESULT

MeSH Terms

Conditions

Cleft LipCicatrix

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Massimo Cordaro, Medicine

    Catholic University of the Sacred Hearth - Rome

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

January 3, 2018

First Posted

January 9, 2018

Study Start

June 5, 2017

Primary Completion

July 20, 2017

Study Completion

December 22, 2017

Last Updated

January 9, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share
Shared Documents
ICF
Time Frame
The data will be available as soon as the study will be registered. The informed consent form is written in italian

Locations

IT(1)