Orthodontic Appliance ComplicationNCT06518733
Orthodontic Treatment Impact on Life Experience of Adolescents With Fixed Orthodontic Appliances
An observational study of Orthodontic Appliance Complication, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- appliance type
- How many people
- 364 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Egyptian adolescent patients with age 13-18 with fixed orthodontic appliances
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- appliance type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
appliance typeOther
different types of appliances: labial fixed appliances only, fixed retainers, palatal appliances and miniscrews
| Study group | Role | What they receive |
|---|---|---|
| Group A | patients with fixed labial orthodontic appliance Receives: Other: appliance type | |
| Group B | patients with fixed labial appliance with palatal appliances Receives: Other: appliance type | |
| Group C | patients with fixed labial appliance with miniscrews Receives: Other: appliance type | |
| Group D | patients with fixed labial appliance with both palatal appliances and miniscrews Receives: Other: appliance type | |
| Group E | patients with fixed retainer Receives: Other: appliance type |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the intervention
Secondary outcomes (1)
Impact on the oral health, pain, and discomfort of the respondent
Impact on the oral health, pain, and discomfort of the respondent is assessed using a questionnaire
Measured: during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Aug 2023
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Mohamed Gaber, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518733
- Sponsor's protocol ID
- 11543267
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthodontic Treatment Impact on Day-to-Day Life Experience of Adolescents With Fixed Orthodontic Appliances: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06518733
- Acronym / sponsor ID
- 11543267
- Conditions
- Orthodontic Appliance Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: appliance typepatients with fixed labial orthodontic appliance |
| Group B | – | Other: appliance typepatients with fixed labial appliance with palatal appliances |
| Group C | – | Other: appliance typepatients with fixed labial appliance with miniscrews |
| Group D | – | Other: appliance typepatients with fixed labial appliance with both palatal appliances and miniscrews |
| Group E | – | Other: appliance typepatients with fixed retainer |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Egyptian adolescent patients with age 13-18 with fixed orthodontic appliances
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| appliance typedifferent types of appliances: labial fixed appliances only, fixed retainers, palatal appliances and miniscrews | Other | Group A, Group B, Group C, Group D, Group E |
Primary outcome
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
1 secondary outcome
Impact on the oral health, pain, and discomfort of the respondent
Time frame: during the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: Undecided
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The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain
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Comparison of a 3-step Bonding System (Transbond™ XT) and a 2-step System (GC Ortho Connect™) on Demineralization Around Maxillary Orthodontic Brackets
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthodontic Appliance Complication, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on the social and emotional well-being status of the patient. (time frame: during the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.