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Completed

NCT Number: NCT05500456

The Effectiveness of Clear Aligner and Traditional Fixed Appliances in Achieving Good Occlusion in Complex Orthodontic Cases

Patients who have severe crowding that requires four premolars extraction will be treated in this study. The efficacy and effectiveness of in-house clear aligners therapy compared with vestibular fixed appliances in the treatment of severe crowding malocclusion cases requiring the extraction of first premolars will be evaluated using Little's irregularity index (LII), Peer assessment rating index (PAR), and treatment duration.

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

Crowding, Tooth Behavior Crowding Malocclusion Spatial Behavior Stomatognathic Diseases Tooth Diseases

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Damascus

Damascus, Syria

About this study

For years, orthodontists and dentists have used removable appliances for orthodontic treatment. 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 skeletal and dental malocclusion
  • severe crowding (more than 6 mm of tooth size-arch length discrepancy)
  • Good oral hygiene and periodontal health.
  • 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

  • Subject with psychological abnormalities.
  • Subject with systemic diseases.
  • Previous orthodontic treatment.
  • Subject has known allergy to latex and plastic

Treatment and study plan

Clear aligners

Device

Each aligner will be worn for about two weeks, and then replaced by the next in the series until the final position is achieved.

Fixed appliances

Device

Conventional wires and brackets will be used.

Primary outcomes

  1. Change in PAR index

    Time frame: T0: one day before the commencement of treatment. T1: one day following the end of treatment

    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 buccazzzl occlusion (RBO, LBO). The score of each component is summed up to a total PAR score. A reduction in the PAR score of at least 30% classifies the case as 'improved'. A reduction of 22 points or more in the weighted PAR score classifies the case as 'greatly improved'. Improvements smaller than 30% are declared as 'worse or no different'

  2. Changes in Little's irregularity index

    Time frame: T0: one day before the commencement of treatment. T1: one day following the end of treatment

    The Little's index measures the linear displacements in the horizontal plane between the contact points of the anterior teeth from the mesial surface of one canine to the contralateral one. The LII score is the sum of these linear measurements, and a higher score value indicates more severe irregularities of the anterior teeth

Secondary outcomes

  1. Treatment time

    Time frame: T1: one day following the end of treatment

    The treatment duration was calculated by months and will be compared between the groups

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation of the Achieved Occlusal Relationships Using the PAR Index Between the In-house Constructed Clear Aligners and Fixed Appliances in Patients With Extraction-based Treatment Plans: A Randomized Control Clinical Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 15, 2022
Registry last updated
Aug 15, 2022

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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