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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03395015
Recruitment Status : Completed
First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Sponsor:
Collaborators:
Prof. Massimo Cordaro
Dr. Romeo Patini
Dr. Oliva Giorgio
Dr. Candida Ettore
Dr. De Luca Marilisa
Dr. Rizzo Maria Ida
Dr. Zama Mario
Dr. Rajabtork Zadeh Oriana
Dr. Bucci Daria
Prof. Gallenzi Patrizia
Information provided by (Responsible Party):
Dr. Edoardo Staderini, 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.


Condition or disease Intervention/treatment
Cleft Lip and Palate Growth and Development Cicatrix Randomized Controlled Trial Other: VAS scale (from 1 to 10) esthetic assessment of facial 3-D images

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.

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Efficacia Del Trattamento Chirurgico Maxillo-facciale Sul Volto Dei Bambini Con Labiopalatoschisi: Valutazioni Estetiche ed Ortodontiche
Actual Study Start Date : June 5, 2017
Actual Primary Completion Date : July 20, 2017
Actual Study Completion Date : December 22, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.

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
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 Outcome Measures :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The raters selection is aiming to have an equal number of male and female judges.
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395015


Locations
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Italy
Catholic University of the Sacred Heart
Roma, Italia, Italy, 00168
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Prof. Massimo Cordaro
Dr. Romeo Patini
Dr. Oliva Giorgio
Dr. Candida Ettore
Dr. De Luca Marilisa
Dr. Rizzo Maria Ida
Dr. Zama Mario
Dr. Rajabtork Zadeh Oriana
Dr. Bucci Daria
Prof. Gallenzi Patrizia
Investigators
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Principal Investigator: Massimo Cordaro, Medicine Catholic University of the Sacred Hearth - Rome
Publications of Results:

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Responsible Party: Dr. Edoardo Staderini, PhD student, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT03395015    
Other Study ID Numbers: 0027003/17
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Informed Consent Form (ICF)
Time Frame: The data will be available as soon as the study will be registered. The informed consent form is written in italian

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Edoardo Staderini, Fondazione Policlinico Universitario Agostino Gemelli IRCCS:
Reconstructive surgical procedures
Therapy, soft tissue
Treatment outcome
Outcome Assessment (Health Care)
Photogrammetry
Physical Appearance, Body
Additional relevant MeSH terms:
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Cleft Lip
Cicatrix
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Fibrosis
Pathologic Processes