An interventional study of Fixed Appliances and Clear Aligners in Malocclusion, Angle Class I, Malocclusion; Displaced or Missing Teeth and Crowding, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2023-02-22.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
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.
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.
35 studies on the registry are indexed under Malocclusion, Angle Class I; 10 are open to participants now.
This study's enrollment of 40 is above the median of 32 across 31 interventional studies indexed under Malocclusion, Angle Class I.
Browse Malocclusion, Angle Class I studies →Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
patients will be treated using fixed appliances in order to align their teeth after extraction of four premolars
Device: Fixed Appliances
patients will be treated using clear aligners in order to align their teeth after extraction of four premolars
Device: Clear Aligners
Using an MBT-prescription of metallic brackets, patients will be treated in the conventional way
Using a sequence of clear aligners, patients will be give an aligner every two weeks until the completion of treatment
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.
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)
Plan to share: No
Ran from Aug 2018 to primary completion in Dec 2021, 39 months.
Of 23 interventional studies with no phase under Malocclusion, Angle Class I, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 24. This study's 39 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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