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Completed

NCT Number: NCT06539572

Perception of Appearance and Social Acceptance Between Cleft and Non-Cleft Children in Early Adolescence

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.

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Key information

Conditions

Cleft Lip and Palate Behavior Cleft Lip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Lip Diseases Mouth Abnormalities Mouth Diseases Social Behavior Social Isolation Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital

Taoyuan, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cleft lip repair; palatoplasty; alveolar bone grafting

Procedure

cleft surgical treatment based on Chang Gung Craniofacial Center Protocol for cleft treatment

Primary outcomes

  1. Facial appearance

    Time frame: 6 months after alveolar bone grafting

    based on 3dMD image

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Perception of Appearance and Social Acceptance Between Cleft and Non-Cleft Children in Early Adolescence: Questionnaire Analysis Based on 3dMD Images

Acronym: Cleft social

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 6, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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