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Malocclusion, Angle Class INCT03645356

Comparison Between Clear Aligners and Traditional Fixed Appliances in the Treatment of Four-premolar-extraction Cases

A study testing Fixed Appliances and Clear Aligners in people with Malocclusion, Angle Class I and Malocclusion; Displaced or Missing 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 severe crowding that require four premolars extraction will be treated in this study. The efficacy of the clear aligners and vestibular fixed appliances will be assessed. Read more about this study

Who is it for?
Ages 18 to 25 years
What is being tested?
Fixed Appliances and Clear Aligners
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSyria
Study dates
19 Aug 2018to 20 Jul 2022
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 malocclusion with severe crowding (more than 5 mm of tooth-size-arch-length-discrepancy).
  • Good oral hygiene and periodontal health.
  • No severe skeletal discrepancy.
  • Normal proclination for the upper and lower incisors.
  • 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

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

Trial locations and contacts

1 site in 1 country.

Syria1 site

  • Department of Orthodontics, University of Damascus Dental School

    Damascus, DM20AM18

Other trials in Syria

About this study

Official title: Evaluation of the Efficacy of Clear Aligners in the Correction of Severe Dental Crowding Cases Combined With Premolar Extraction Versus Vestibular Fixed Orthodontic Appliances: A Randomized Clinical Controlled Trial

Patients who have severe crowding that require four premolars extraction will be treated in this study. The efficacy of the clear aligners and vestibular fixed appliances will be assessed. The treatment result of these two different methods will be explored using the Peer Assessment Rating (PAR) in two different times (T0: Before treatment, T1: After treatment) and the American Board of Orthodontics Objective Grading System (ABO-OGS) after treatment (T1).

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. Today, 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.

Being tested
Fixed Appliances, Clear Aligners
Medical subject headings
Malocclusion, Angle Class I, Malocclusion, Anodontia, Crowding

What participants receive

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

  • Fixed AppliancesDevice

    Using an MBT-prescription of metallic brackets, patients will be treated in the conventional way

  • Clear AlignersDevice

    Using a sequence of clear aligners, patients will be give an aligner every two weeks until the completion of treatment

Study groups in NCT03645356
Study groupRoleWhat they receive
fixed appliancesActive comparatorpatients will be treated using fixed appliances in order to align their teeth after extraction of four premolars
Receives: Device: Fixed Appliances
clear alignersExperimentalpatients will be treated using clear aligners in order to align their teeth after extraction of four premolars
Receives: Device: Clear Aligners

What is being measured

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

  1. Change in the American Board of Orthodontics - Objective Grading System (ABO-OGS)

    Eight domains are evaluated:

    Alignment: No more than 2 points shall be subtracted for any tooth when it is poorly aligned; Marginal Ridges: The total number of deductions shall be subtracted from 32 to give the score for this domain; Buccolingual inclination: If the mandibular lingual cusps or maxillary buccal cusps are more than 1 mm from the straight edge surface, 1 point shall be subtracted for that tooth; Occlusal Contacts: If a cusp is out of contact with the opposing arch, 1 point is subtracted for that tooth; Occlusal relationships. The total number of deductions are subtracted from 24 to give the score for occlusal relationships; Overjet; Interproximal contacts. If no interproximal spaces exist, then no points are subtracted; and Root angulation: Any deviations in roots' angulations will cause a deduction form the general score. Finally, a case that loses more than 30 points will be considered a failure. A case that loses less than 20 points will be considered acceptable.

    Measured: T1: one day before the commencement of treatment. T2: one day following the end of treatment (that is expected to happen within 24 months)

Timeline

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

  1. First posted24 Aug 2018
  2. Study start19 Aug 2018
  3. Primary completion10 Dec 2021
  4. Study completion20 Jul 2022

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03645356
Sponsor's protocol ID
UDDS-Ortho-07-2018
Status last verified
Feb 2023
First submitted
22 Aug 2018
Last updated
22 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bollen AM, Huang G, King G, Hujoel P, Ma T. Activation time and material stiffness of sequential removable orthodontic appliances. Part 1: Ability to complete treatment. Am J Orthod Dentofacial Orthop. 2003 Nov;124(5):496-501. doi: 10.1016/s0889-5406(03)00576-6.

    PubMed 14614415

  • Drake CT, McGorray SP, Dolce C, Nair M, Wheeler TT. Orthodontic tooth movement with clear aligners. ISRN Dent. 2012;2012:657973. doi: 10.5402/2012/657973. Epub 2012 Aug 14.

    PubMed 22928114

  • Giancotti A, Di Girolamo R. Treatment of severe maxillary crowding using Invisalign and fixed appliances. J Clin Orthod. 2009 Sep;43(9):583-9; quiz 582. No abstract available.

    PubMed 19904051

  • Hennessy J, Al-Awadhi EA. Clear aligners generations and orthodontic tooth movement. J Orthod. 2016 Mar;43(1):68-76. doi: 10.1179/1465313315Y.0000000004.

    PubMed 25939782

  • Kravitz ND, Kusnoto B, BeGole E, Obrez A, Agran B. How well does Invisalign work? A prospective clinical study evaluating the efficacy of tooth movement with Invisalign. Am J Orthod Dentofacial Orthop. 2009 Jan;135(1):27-35. doi: 10.1016/j.ajodo.2007.05.018.

    PubMed 19121497

  • 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

  • Zhang XJ, He L, Guo HM, Tian J, Bai YX, Li S. Integrated three-dimensional digital assessment of accuracy of anterior tooth movement using clear aligners. Korean J Orthod. 2015 Nov;45(6):275-81. doi: 10.4041/kjod.2015.45.6.275. Epub 2015 Nov 20.

    PubMed 26629473

Questions about this trial

What is this clinical trial studying?

A study testing Fixed Appliances and Clear Aligners in people with Malocclusion, Angle Class I and Malocclusion; Displaced or Missing 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 6 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 22 Feb 2023. 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 the American Board of Orthodontics - Objective Grading System (ABO-OGS) (time frame: T1: one day before the commencement of treatment. T2: one day following the end of treatment (that is expected to happen within 24 months)). 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 NCT03645356, 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 22 Feb 2023.

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