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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Damascus University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in the American Board of Orthodontics - Objective Grading System (ABO-OGS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 25 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
fixed appliances
patients will be treated using fixed appliances in order to align their teeth after extraction of four premolars
Intervention: Fixed Appliances (Device)
clear aligners
patients will be treated using clear aligners in order to align their teeth after extraction of four premolars
Intervention: Clear Aligners (Device)
Outcomes
Primary Outcomes
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)
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.
Secondary Outcomes
No secondary outcomes reported