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

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

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.

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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