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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03645356
Enrollment
40
Registered
2018-08-24
Start date
2018-08-19
Completion date
2022-07-20
Last updated
2023-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion, Angle Class I, Malocclusion; Displaced or Missing Teeth, Crowding

Brief 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. 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.

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.

Interventions

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

Sponsors

Damascus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the American Board of Orthodontics - Objective Grading System (ABO-OGS)T1: one day before the commencement of treatment. T2: one day following the end of treatment (that is expected to happen within 24 months)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.

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026