NCT06518733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
364

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

July 17, 2024

Last Update Submit

July 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Impact on the social and emotional well-being status of the patient.

    impact social and emotional well-being status of the patient is assessed using a questionnaire

    during the intervention

Secondary Outcomes (1)

  • Impact on the oral health, pain, and discomfort of the respondent

    during the intervention

Study Arms (5)

Group A

patients with fixed labial orthodontic appliance

Other: appliance type

Group B

patients with fixed labial appliance with palatal appliances

Other: appliance type

Group C

patients with fixed labial appliance with miniscrews

Other: appliance type

Group D

patients with fixed labial appliance with both palatal appliances and miniscrews

Other: appliance type

Group E

patients with fixed retainer

Other: appliance type

Interventions

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

Group AGroup BGroup CGroup DGroup E

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Egyptian adolescent patients with age 13-18 with fixed orthodontic appliances

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 1234, Egypt

Location

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master candidate

Study Record Dates

First Submitted

July 17, 2024

First Posted

July 24, 2024

Study Start

August 1, 2023

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

July 24, 2024

Record last verified: 2024-07

Locations