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

NCT06539572 | Completed DMC

• 1 other identifier: 202200698B0
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cleft Lip and Palate; Social Isolation

Keywords

Cleft lip and palate; three-dimensional image technique; adolescent peers; aesthetic evaluation; psychosocial impact

Outcome Measures

Primary Outcomes (1)

• Facial appearance

  based on 3dMD image

  6 months after alveolar bone grafting

Study Arms (2)

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

Procedure: Cleft lip repair; palatoplasty; alveolar bone grafting

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.

Interventions

Cleft lip repair; palatoplasty; alveolar bone grafting PROCEDURE

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

Cleft lip and palate

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Cleft patient received cleft surgical treatment including lip repair, palatoplasty, and alveolar bone grafting in our Craniofacial Center, based on our cleft surgical protocol

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Cleft Lip; Social Isolation

Interventions

Alveolar Bone Grafting

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Orthognathic Surgical Procedures; Oral Surgical Procedures; Surgical Procedures, Operative; Osteotomy; Orthopedic Procedures; Dentistry

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 6, 2024
• Study Start: June 14, 2022
• Primary Completion: December 20, 2022
• Study Completion: August 3, 2023
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)