Orthodontic Treatment Impact on Life Experience of Adolescents With Fixed Orthodontic Appliances

Completed

• Conditions: Orthodontic Appliance Complication
• Interventions: Other: appliance type

• Registration Number: NCT06518733
• Lead Sponsor: Cairo University

Brief Summary

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2023-08-01
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-07
• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-22
• Last Update Submitted: 2024-07-22
• Study First Posted: 2024-07-24
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 364

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

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	appliance type	patients with fixed labial orthodontic appliance
Group C	appliance type	patients with fixed labial appliance with miniscrews
Group E	appliance type	patients with fixed retainer
Group B	appliance type	patients with fixed labial appliance with palatal appliances
Group D	appliance type	patients with fixed labial appliance with both palatal appliances and miniscrews

Primary Outcome Measures

Name	Time	Method
Impact on the social and emotional well-being status of the patient.	during the intervention	impact social and emotional well-being status of the patient is assessed using a questionnaire

Secondary Outcome Measures

Name	Time	Method
Impact on the oral health, pain, and discomfort of the respondent	during the intervention	Impact on the oral health, pain, and discomfort of the respondent is assessed using a questionnaire

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt