Cleft Lip and PalateCleft socialNCT06539572
Perception of Appearance and Social Acceptance Between Cleft and Non-Cleft Children in Early Adolescence
An observational study of Cleft Lip and Palate and Social Isolation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate, Social Isolation
- What is being tested?
- Cleft lip repair; palatoplasty; alveolar bone grafting
- Type of treatment
- Surgery or procedure
- How many people
- 91 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Jun 2022to 3 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Cleft patient received cleft surgical treatment including lip repair, palatoplasty, and alveolar bone grafting in our Craniofacial Center, based on our cleft surgical protocol
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cleft Lip and Palate, Social Isolation
- Being tested
- Cleft lip repair; palatoplasty; alveolar bone grafting
- Keywords
- Cleft lip and palate, three-dimensional image technique, adolescent peers, aesthetic evaluation, psychosocial impact
- Medical subject headings
- Cleft Lip, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cleft lip repair; palatoplasty; alveolar bone graftingProcedure or surgery
cleft surgical treatment based on Chang Gung Craniofacial Center Protocol for cleft treatment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial appearance
based on 3dMD image
Measured: 6 months after alveolar bone grafting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start14 Jun 2022
- Primary completion20 Dec 2022
- Study completion3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pang-Yun Chou, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539572
- Sponsor's protocol ID
- 202200698B0
- Acronym
- Cleft social
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of Appearance and Social Acceptance Between Cleft and Non-Cleft Children in Early Adolescence: Questionnaire Analysis Based on 3dMD Images
- ClinicalTrials.gov ID
- NCT06539572
- Acronym / sponsor ID
- Cleft social / 202200698B0
- Conditions
- Cleft Lip and Palate, Social Isolation
- Keywords
- Cleft lip and palate, three-dimensional image technique, adolescent peers, aesthetic evaluation, psychosocial impact
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cleft lip and palate | – | Procedure: Cleft lip repair; palatoplasty; alveolar bone graftingCleft 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 |
| 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. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Cleft patient received cleft surgical treatment including lip repair, palatoplasty, and alveolar bone grafting in our Craniofacial Center, based on our cleft surgical protocol
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cleft lip repair; palatoplasty; alveolar bone graftingcleft surgical treatment based on Chang Gung Craniofacial Center Protocol for cleft treatment | Procedure or surgery | Cleft lip and palate |
Primary outcome
Facial appearance
Time frame: 6 months after alveolar bone grafting
based on 3dMD image
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Lip and Palate and Social Isolation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial appearance (time frame: 6 months after alveolar bone grafting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.