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Completed

NCT Number: NCT06518733

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

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.

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairo University

Cairo, 1234, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

appliance type

Other

different types of appliances: labial fixed appliances only, fixed retainers, palatal appliances and miniscrews

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Orthodontic Treatment Impact on Day-to-Day Life Experience of Adolescents With Fixed Orthodontic Appliances: A Cross-Sectional Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 24, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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