Comparison Between Clear Aligners and Traditional Fixed Appliances in the Treatment of Four-premolar-extraction Cases
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: fixed appliances patients will be treated using fixed appliances in order to align their teeth after extraction of four premolars |
Device: Fixed Appliances
Using an MBT-prescription of metallic brackets, patients will be treated in the conventional way
|
| Experimental: clear aligners patients will be treated using clear aligners in order to align their teeth after extraction of four premolars |
Device: Clear Aligners
Using a sequence of clear aligners, patients will be give an aligner every two weeks until the completion of treatment
|
Outcome Measures
Primary Outcome Measures
- Change in PAR index [T1: one day before the commencement of treatment. T2: one day following the end of treatment (that is expected to happen within 24 months)]
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 buccal occlusion (RBO, LBO). Then the weighted PAR index score will be calculated according to the American wightining system as follows: UAS times 1, RBO and LBO times 2, OJ and OB times 3 and MID times 2. A perfect occlusion would receive a score of zero, a score from one to nine indicates that good dental relationships are present; a score above 40 indicates severe malocclusion.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Class I malocclusion with severe crowding (more than 5 mm of tooth-size-arch-length-discrepancy).
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Good oral hygiene and periodontal health.
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No severe skeletal discrepancy.
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Normal proclination for the upper and lower incisors.
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No congenitally missing or extracted teeth (except for the third molars).
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No history of previous trauma to the maxillofacial region or surgical interventions.
Exclusion Criteria:
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Bimaxillary dentoalveolar severe protrusion.
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Previous orthodontic treatment.
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Subject with psychological abnormalities.
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Subject with systemic diseases.
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Subject has known allergy to latex and plastic
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Orthodontics, University of Damascus Dental School | Damascus | Syrian Arab Republic | DM20AM18 |
Sponsors and Collaborators
- Damascus University
Investigators
- Principal Investigator: Samer T Jaber, DDS MSc, PhD Student in Orthodontics, University of Damascus Dental School, Damascus
- Study Chair: Mohammad Y Hajeer, DDS MSc PhD, Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
Study Documents (Full-Text)
None provided.More Information
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- UDDS-Ortho-07-2018