- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06539572
Perception of Appearance and Social Acceptance Between Cleft and Non-Cleft Children in Early Adolescence (Cleft social)
Perception of Appearance and Social Acceptance Between Cleft and Non-Cleft Children in Early Adolescence: Questionnaire Analysis Based on 3dMD Images
Background: Using three-dimensional (3D) surface imaging, this study aims to understand the differences in perception between schoolchildren with and without cleft lip and palate (CLP), as well as to explore peer awareness and acceptance of children with craniofacial abnormalities post-surgery.
Methods: This cross-sectional study utilized three-dimensional surface images of early adolescent patients with CLP post-repair and without CLP for examination by schoolchildren (with CLP and without). Both groups assessed the images and responded to a questionnaire eliciting perceptions of facial appearance and social acceptance of children with craniofacial abnormalities, rating each question on a Likert scale of one to five. The results were presented using bar graphs, and the Item Response Theory-Graded Response Model was employed to estimate the latent ability (θ) of each participant. The reliability of the questionnaire was assessed with Cronbach's alpha test.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Taoyuan, Taiwan
- Chang Gung Memorial Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
<Acquisition of 3D Image>
- Cleft: Images of subjects with and without craniofacial anomalies were extracted from the database at the Chang Gung Craniofacial Research Center; taken before and after alveolar bone graft surgery at a six-month interval, from 2017 to 2020; aged about 9.
- Noncleft: healthy pediatric individuals from six to 12 years of age. Randomly selected from the database, aged 9-12
<Participants for questionnaires>
- CLP patients and non-cleft children aged 10-12 were randomly recruited
- Patients with CLP were sourced from individuals who had undergone surgical treatment and received regular follow-ups in our Craniofacial Center; the non-cleft cases were recruited from various elementary schools in the Guishan district of Taoyuan City, Taiwan.
Description
Inclusion Criteria:
- Cleft patient received cleft surgical treatment including lip repair, palatoplasty, and alveolar bone grafting in our Craniofacial Center, based on our cleft surgical protocol
Exclusion Criteria:
- Unable to complete the questionnaire on their own for any reason were excluded to avoid bias in responses caused by the presence of a secondary observer
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cleft lip and palate
Cleft lip and palate patients, undergone surgical treatment and received regular follow-ups in the Chang Gung Craniofacial Center; aged 10-12; after alveolar bone grafting surgery
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cleft surgical treatment based on Chang Gung Craniofacial Center Protocol for cleft treatment
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Non-cleft
Non cleft cohort as control group; recruited from various elementary schools in the Guishan district of Taoyuan City, Taiwan; aged 10-12; without craniofacial anomalies.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Facial appearance
Time Frame: 6 months after alveolar bone grafting
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based on 3dMD image
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6 months after alveolar bone grafting
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202200698B0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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