- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06518733
Orthodontic Treatment Impact on Life Experience of Adolescents With Fixed Orthodontic Appliances
July 22, 2024 updated by: Shimaa Mohamed Gaber, Cairo University
Orthodontic Treatment Impact on Day-to-Day Life Experience of Adolescents With Fixed Orthodontic Appliances: A Cross-Sectional Study
This cross-sectional study aimed to investigate the impact of different fixed orthodontic appliances on the day-to-day life experience of adolescent patients at any stage of their orthodontic treatment.
A validated questionnaire was translated and used in the assessment, 364 patients (242 female and 122 male) were recruited, impact on the social and emotional well-being status of the participants was assessed as well as oral health, pain, and discomfort.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This cross-sectional study aimed to evaluate the impact of orthodontic treatment on the daily life experience of adolescents wearing fixed orthodontic appliances.
We aimed to assess the impact of different fixed orthodontic appliances in a sample of 364 patients either having labial fixed orthodontic appliances only or combined with palatal anchorage appliances, combined with mini-screws, combined with both palatal anchorage appliances and mini-screws or having fixed retainers.
The outcomes were the impact on the patient's social and emotional well-being status and the impact on the patient's oral health, pain, and discomfort.
a questionnaire was distributed and the patient was asked to fill it in.
The questionnaire is composed of 22 questions with a 3-point scale.
Study Type
Observational
Enrollment (Actual)
364
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 1234
- Cairo university
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Egyptian adolescent patients with age 13-18 with fixed orthodontic appliances
Description
Inclusion Criteria:
- Male and female patients
- Patients wearing fixed orthodontic appliances at any stage of treatment (labial fixed appliance only - labial fixed appliance combined with any palatal or lingual appliance - labial fixed appliance combined with mini-screws) or fixed retainers either in the upper arch only, lower arch only, or in both arches.
- Age: 13-18 years old
Exclusion Criteria:
- Patients who refused to participate in the study.
- Patients with cleft lip or palate.
- Illiterate patients.
- Patients who had a complicated medical history.
- Patients with severe skeletal discrepancy undergoing combined orthodontic and orthognathic surgical treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group A
patients with fixed labial orthodontic appliance
|
different types of appliances: labial fixed appliances only, fixed retainers, palatal appliances and miniscrews
|
|
Group B
patients with fixed labial appliance with palatal appliances
|
different types of appliances: labial fixed appliances only, fixed retainers, palatal appliances and miniscrews
|
|
Group C
patients with fixed labial appliance with miniscrews
|
different types of appliances: labial fixed appliances only, fixed retainers, palatal appliances and miniscrews
|
|
Group D
patients with fixed labial appliance with both palatal appliances and miniscrews
|
different types of appliances: labial fixed appliances only, fixed retainers, palatal appliances and miniscrews
|
|
Group E
patients with fixed retainer
|
different types of appliances: labial fixed appliances only, fixed retainers, palatal appliances and miniscrews
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact on the social and emotional well-being status of the patient.
Time Frame: during the intervention
|
impact social and emotional well-being status of the patient is assessed using a questionnaire
|
during the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact on the oral health, pain, and discomfort of the respondent
Time Frame: during the intervention
|
Impact on the oral health, pain, and discomfort of the respondent is assessed using a questionnaire
|
during the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2023
Primary Completion (Actual)
December 30, 2023
Study Completion (Actual)
December 30, 2023
Study Registration Dates
First Submitted
July 17, 2024
First Submitted That Met QC Criteria
July 22, 2024
First Posted (Actual)
July 24, 2024
Study Record Updates
Last Update Posted (Actual)
July 24, 2024
Last Update Submitted That Met QC Criteria
July 22, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 11543267
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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