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

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.

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Key information

Conditions

Malocclusion, Angle Class I Anodontia Behavior Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crowding Malocclusion Malocclusion; Displaced or Missing Teeth Spatial Behavior Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fixed appliances

Device

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

Clear aligners

Device

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

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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study 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

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2022
First posted: Aug 24, 2018
Registry last updated: Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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