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Crowding, ToothNCT05500456

The Effectiveness of Clear Aligner and Traditional Fixed Appliances in Achieving Good Occlusion in Complex Orthodontic Cases

A study testing Clear aligners and Fixed appliances in people with Crowding, Tooth, 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 severe crowding that requires four premolars extraction will be treated in this study. The efficacy and effectiveness of in-house clear aligners therapy compared with vestibular fixed appliances in the treatment of severe crowding malocclusion cases requiring the extraction of first premolars will be… Read more about this study

Who is it for?
Ages 18 to 25 years
Conditions the study is for
Crowding, Tooth
What is being tested?
Clear aligners and 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
11 May 2019to 15 Dec 2021
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

  • Class I skeletal and dental malocclusion
  • severe crowding (more than 6 mm of tooth size-arch length discrepancy)
  • Good oral hygiene and periodontal health.
  • No congenitally missing or extracted teeth (except for the third molars).
  • No history of previous trauma to the maxillofacial region or surgical interventions.

Who cannot join

  • Subject with psychological abnormalities.
  • Subject with systemic diseases.
  • Previous orthodontic treatment.
  • Subject has known allergy to latex and plastic

Trial locations and contacts

1 site in 1 country.

Syria1 site

  • University of Damascus

    Damascus

Other trials in Syria

About this study

Official title: Evaluation of the Achieved Occlusal Relationships Using the PAR Index Between the In-house Constructed Clear Aligners and Fixed Appliances in Patients With Extraction-based Treatment Plans: A Randomized Control Clinical Trial

Patients who have severe crowding that requires four premolars extraction will be treated in this study. The efficacy and effectiveness of in-house clear aligners therapy compared with vestibular fixed appliances in the treatment of severe crowding malocclusion cases requiring the extraction of first premolars will be evaluated using Little's irregularity index (LII), Peer assessment rating index (PAR), and treatment duration.

There are two groups:

First group (Experimental): the patients in this group will be treated using clear aligners.

Second group (Control): the patients in this group will be treated using fixed appliances.

Read the detailed description

For years, orthodontists and dentists have used removable appliances for orthodontic treatment. With the CAD/CAM technology, clear aligners treat a broader range of cases with greater precision. They consist of a series of plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom-manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved.

Conditions
Crowding, Tooth
Being tested
Clear aligners, Fixed appliances
Keywords
Clear aligners, PAR index, Vestibular fixed appliances, Orthodontics, Crowding, Treatment duration
Medical subject headings
Malocclusion, Crowding

What participants receive

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

  • Clear alignersDevice

    Each aligner will be worn for about two weeks, and then replaced by the next in the series until the final position is achieved.

  • Fixed appliancesDevice

    Conventional wires and brackets will be used.

Study groups in NCT05500456
Study groupRoleWhat they receive
Clear alignersExperimentalThe patients in this group will be treated using clear aligners.
Receives: Device: Clear aligners
Fixed appliances.Active comparatorThe patients in this group will be treated using fixed appliances.
Receives: Device: Fixed appliances

What is being measured

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

  1. Change in PAR index

    The PAR index will be used to provide objective assessment of treatment success. Each set of dental models prepared before and after treatment for each case will be occluded in maximum intercuspation and a calibrated PAR ruler is used to assign a value to each of the PAR index components: contact displacement in the upper and lower labial segment (UAS), overjet (OJ), overbite (OB), medline deviation (MID) and right and left buccazzzl occlusion (RBO, LBO). The score of each component is summed up to a total PAR score. A reduction in the PAR score of at least 30% classifies the case as 'improved'. A reduction of 22 points or more in the weighted PAR score classifies the case as 'greatly improved'. Improvements smaller than 30% are declared as 'worse or no different'

    Measured: T0: one day before the commencement of treatment. T1: one day following the end of treatment

  2. Changes in Little's irregularity index

    The Little's index measures the linear displacements in the horizontal plane between the contact points of the anterior teeth from the mesial surface of one canine to the contralateral one. The LII score is the sum of these linear measurements, and a higher score value indicates more severe irregularities of the anterior teeth

    Measured: T0: one day before the commencement of treatment. T1: one day following the end of treatment

Secondary outcomes (1)

  1. Treatment time

    The treatment duration was calculated by months and will be compared between the groups

    Measured: T1: one day following the end of treatment

Timeline

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

  1. First posted15 Aug 2022
  2. Study start11 May 2019
  3. Primary completion1 Mar 2021
  4. Study completion15 Dec 2021

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
NCT05500456
Sponsor's protocol ID
UDDS-Ortho-13-2022
Status last verified
Aug 2022
First submitted
11 Aug 2022
Last updated
15 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jaber ST, Hajeer MY, Burhan AS, Latifeh Y. The Effect of Treatment With Clear Aligners Versus Fixed Appliances on Oral Health-Related Quality of Life in Patients With Severe Crowding: A One-Year Follow-Up Randomized Controlled Clinical Trial. Cureus. 2022 May 30;14(5):e25472. doi: 10.7759/cureus.25472. eCollection 2022 May.

    PubMed 35663697

  • Jaber ST, Hajeer MY, Khattab TZ, Mahaini L. Evaluation of the fused deposition modeling and the digital light processing techniques in terms of dimensional accuracy of printing dental models used for the fabrication of clear aligners. Clin Exp Dent Res. 2021 Aug;7(4):591-600. doi: 10.1002/cre2.366. Epub 2020 Nov 30.

    PubMed 33258297

  • Li W, Wang S, Zhang Y. The effectiveness of the Invisalign appliance in extraction cases using the the ABO model grading system: a multicenter randomized controlled trial. Int J Clin Exp Med. 2015 May 15;8(5):8276-82. eCollection 2015.

    PubMed 26221410

  • Liu S, Oh H, Chambers DW, Baumrind S, Xu T. Validity of the American Board of Orthodontics Discrepancy Index and the Peer Assessment Rating Index for comprehensive evaluation of malocclusion severity. Orthod Craniofac Res. 2017 Aug;20(3):140-145. doi: 10.1111/ocr.12195. Epub 2017 Jul 3.

    PubMed 28670875

  • KESLING HD. Coordinating the predetermined pattern and tooth positioner with conventional treatment. Am J Orthod Oral Surg. 1946 May;32:285-93. doi: 10.1016/0096-6347(46)90053-1. No abstract available.

    PubMed 21027613

Questions about this trial

What is this clinical trial studying?

A study testing Clear aligners and Fixed appliances in people with Crowding, Tooth, 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 5 inclusion and 4 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 15 Aug 2022. 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?

Change in PAR index (time frame: T0: one day before the commencement of treatment. T1: one day following the end of treatment). The study lists 2 primary outcomes in all. 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 NCT05500456, which also lists 5 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 15 Aug 2022.

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