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Crowding of Anterior Mandibular TeethNCT06401382

Oral Health-Related Quality of Life Between Two Different Types of Orthodontic Appliances

A study testing A modified aligner appliance with NiTi springs and Conventional fixed appliances in people with Crowding of Anterior Mandibular Teeth, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients who have mild crowding from the Orthodontic Department at University of Damascus Dental School will be treated in this trial. The effects of modified aligner appliance with NiTi springs on oral health-related quality of life (OHRQoL) compared with conventional fixed appliances using the OHIP-14 questionnaire… Read more about this study

Who is it for?
Ages 18 to 25 years
Conditions the study is for
Crowding of Anterior Mandibular Teeth
What is being tested?
A modified aligner appliance with NiTi springs and Conventional fixed appliances
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteSyria
Study dates
2 Jun 2022to 3 Nov 2023
Phase
Interventional
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 18 to 25 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients aged between (18 - 25) years.
  • Mild crowding < 4 mm in the lower dental arch with class I malocclusion
  • No congenitally missing or extracted teeth (except for third molars)
  • Patients with good oral hygiene.

Who cannot join

  • Bimaxillary dentoalveolar protrusion.
  • Previous orthodontic treatment.
  • Severe skeletal discrepancy.

Trial locations and contacts

1 site in 1 country.

Syria1 site

  • Department of Orthodontics, University of Damascus Dental School

    Damascus

Other trials in Syria

About this study

Official title: The Impact of A Modified Aligner Appliance With NiTi Springs and Conventional Fixed Appliances on Oral Health-related Quality of Life in Patients With Mild Crowding

Patients who have mild crowding from the Orthodontic Department at University of Damascus Dental School will be treated in this trial. The effects of modified aligner appliance with NiTi springs on oral health-related quality of life (OHRQoL) compared with conventional fixed appliances using the OHIP-14 questionnaire during orthodontic treatment. So, this study aims to compare the changes in OHRQoL between patients receiving modified aligner appliances or conventional fixed appliances during orthodontic treatment.

There are two groups:

  1. Experimental group: the patients in this group will be treated using a modified aligner appliance.
  2. Control group: the patients in this group will be treated using conventional fixed appliances
Read the detailed description

Most adult patients do not choose traditional fixed appliances due to concerns about appearance, lengthy treatment time, and challenges with oral hygiene. This study aimed to assess the impact on psychological well-being, aesthetics, and functionality of a novel single aligner appliance.

Being tested
A modified aligner appliance with NiTi springs, Conventional fixed appliances

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A modified aligner appliance with NiTi springsDevice

    The modified aligner appliance will be used until the final position is achieved.

  • Conventional fixed appliancesDevice

    The traditional fixed appliances with a standard prescription will be used.

Study groups in NCT06401382
Study groupRoleWhat they receive
Modified aligner appliance with NiTi springsExperimentalThe patients in this group will be treated using a Modified aligner appliance with NiTi springs.
Receives: Device: A modified aligner appliance with NiTi springs
Conventional fixed appliancesActive comparatorThe patients in this group will be treated using conventional fixed appliances.
Receives: Device: Conventional fixed appliances

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in oral health related quality of life

    Patients in both groups will receive a survey called the Oral-Health-Impact-Profile with 14 items (OHIP-14) to complete at every adjustment visit. The OHIP-14 questionnaire assesses various aspects of the individual's oral health, functional well-being, emotional well-being, expectations, and satisfaction with care, and sense of self through subjective evaluation. The total score can range from 0 to 56, with higher scores indicating poorer OHRQoL. Each domain within the OHIP-14 score is also rated on a scale of 0 to 8, with individual items contributing a score of 0 to 4.

    Measured: T0: immediately before the start of orthodontic treatment; T1: after two weeks; T2: after one months; T3: after two months; T4: post-treatment

Secondary outcomes (3)

  1. Patient satisfaction with the progress of the treatment

    Patients in both groups will be asked one question about their satisfaction with the treatment's progress. This question records satisfaction using a 100 mm visual analog scale (VAS). The left end of the line refers to no satisfaction (VAS=0), whereas the right end refers to maximum satisfaction (VAS=100).

    Measured: At the end of treatment which is expected to occur within 4 to 6 months

  2. Patient satisfaction with the appearance of the orthodontic appliance

    Patients in both groups will be asked one question about satisfaction with the appearance of the orthodontic appliance. This question records satisfaction using a 100 mm visual analog scale (VAS). The left end of the line refers to no satisfaction (VAS=0), whereas the right end refers to maximum satisfaction (VAS=100).

    Measured: At the end of treatment which is expected to occur within 4 to 6 months

  3. Patient satisfaction with the results of the treatment

    Patients in both groups will be asked one question about their satisfaction with the treatment's results. This question records satisfaction using a 100 mm visual analog scale (VAS). The left end of the line refers to no satisfaction (VAS=0), whereas the right end refers to maximum satisfaction (VAS=100).

    Measured: At the end of treatment which is expected to occur within 4 to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2024
  2. Study start2 Jun 2022
  3. Primary completion13 Feb 2023
  4. Study completion3 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06401382
Sponsor's protocol ID
UDDS-Ortho-2-2024
Status last verified
May 2024
First submitted
2 May 2024
Last updated
6 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang M, McGrath C, Hagg U. The impact of malocclusion and its treatment on quality of life: a literature review. Int J Paediatr Dent. 2006 Nov;16(6):381-7. doi: 10.1111/j.1365-263X.2006.00768.x.

    PubMed 17014535

  • Masood Y, Masood M, Zainul NN, Araby NB, Hussain SF, Newton T. Impact of malocclusion on oral health related quality of life in young people. Health Qual Life Outcomes. 2013 Feb 26;11:25. doi: 10.1186/1477-7525-11-25.

    PubMed 23443041

  • Zhang B, Huang X, Huo S, Zhang C, Zhao S, Cen X, Zhao Z. Effect of clear aligners on oral health-related quality of life: A systematic review. Orthod Craniofac Res. 2020 Nov;23(4):363-370. doi: 10.1111/ocr.12382. Epub 2020 May 13.

    PubMed 32340082

  • Azaripour A, Weusmann J, Mahmoodi B, Peppas D, Gerhold-Ay A, Van Noorden CJ, Willershausen B. Braces versus Invisalign(R): gingival parameters and patients' satisfaction during treatment: a cross-sectional study. BMC Oral Health. 2015 Jun 24;15:69. doi: 10.1186/s12903-015-0060-4.

    PubMed 26104387

  • Kara-Boulad JM, Burhan AS, Hajeer MY, Khattab TZ, Nawaya FR. Evaluation of the Oral Health-Related Quality of Life (OHRQoL) in Patients Undergoing Lingual Versus Labial Fixed Orthodontic Appliances: A Randomized Controlled Clinical Trial. Cureus. 2022 Mar 22;14(3):e23379. doi: 10.7759/cureus.23379. eCollection 2022 Mar.

    PubMed 35371870

  • Feu D, Oliveira BH, Celeste RK, Miguel JA. Influence of orthodontic treatment on adolescents' self-perceptions of esthetics. Am J Orthod Dentofacial Orthop. 2012 Jun;141(6):743-50. doi: 10.1016/j.ajodo.2011.12.025.

    PubMed 22640676

  • Palomares NB, Celeste RK, Oliveira BH, Miguel JA. How does orthodontic treatment affect young adults' oral health-related quality of life? Am J Orthod Dentofacial Orthop. 2012 Jun;141(6):751-8. doi: 10.1016/j.ajodo.2012.01.015.

    PubMed 22640677

Questions about this trial

What is this clinical trial studying?

A study testing A modified aligner appliance with NiTi springs and Conventional fixed appliances in people with Crowding of Anterior Mandibular Teeth, run by Damascus University at 1 site in Syria.

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 4 inclusion and 3 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 6 May 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 Syria. 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?

Changes in oral health related quality of life (time frame: T0: immediately before the start of orthodontic treatment; T1: after two weeks; T2: after one months; T3: after two months; T4: post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06401382, which also lists 7 linked publications.

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 6 May 2024.

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