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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-11

Study Completion Date

2021-12-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Crowding, Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Clear aligners

The patients in this group will be treated using clear aligners.

Group Type EXPERIMENTAL

Clear aligners

Intervention Type 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.

The patients in this group will be treated using fixed appliances.

Group Type ACTIVE_COMPARATOR

Fixed appliances

Intervention Type DEVICE

Conventional wires and brackets will be used.

Interventions

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Clear aligners

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

Intervention Type DEVICE

Fixed appliances

Conventional wires and brackets will be used.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No