0.018 or 0.022 Bracket Slot System More Effective in Orthodontic Treatment?

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

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2017-03-31

Brief Summary

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The purpose of this study is to compare the 0.018-inch and 0.022-inch bracket slot systems to determine which is more effective for orthodontic treatment .

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Detailed Description

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Background: Edgewise fixed orthodontic appliances are available in two different brackets slot sizes (0.018-inch and 0.022-inch). Both systems are used by clinicians worldwide with many orthodontists claiming clinical advantages and superiority of one system over the other. However, the scientific evidence supporting this area is scarce and weak. This leaves the clinician's choice of bracket slot system to be based mainly on empirical clinical preferences.

Aim: To compare the 0.018-inch and 0.022-inch conventional ligation pre-adjusted orthodontic bracket slot systems in terms of the effectiveness of treatment.

Methods/Design: Prospective, multi-centre randomised clinical trial, undertaken in the secondary care hospital environment in NHS (National Health Service) Tayside in the United Kingdom. Two hundred and sixteen orthodontic patients will be recruited in three secondary care centres in NHS Tayside, United Kingdom. The participants will be randomly allocated to treatment with either the 0.018-inch or 0.022-inch bracket slot systems (n= 108 for each group) using Victory conventional ligation pre-adjusted bracket systems (3M Unitek, Monrovia, California). Baseline records and outcome data will be collected both during and at the end of orthodontic treatment and will be assessed as follows:. Primary outcome measures: The duration of orthodontic treatment for the maxillary and mandibular arches. Secondary outcome measures: The number of scheduled appointments for the maxillary and mandibular arches, occlusal outcome (Peer Assessment Rating index), orthodontically induced inflammatory root resorption using periapical radiographs and the patient perception of wearing orthodontic appliances.

Conditions

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Malocclusion

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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0.018 bracket slot system

Participants treated using 0.018-inch orthodontic bracket slot system

Group Type EXPERIMENTAL

Orthodontic bracket slot system

Intervention Type DEVICE

Orthodontic treatment using different orthodontic bracket slot systems

0.022 bracket slot system

Participants treated using 0.022-inch orthodontic bracket slot system

Group Type ACTIVE_COMPARATOR

Orthodontic bracket slot system

Intervention Type DEVICE

Orthodontic treatment using different orthodontic bracket slot systems

Interventions

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Orthodontic bracket slot system

Orthodontic treatment using different orthodontic bracket slot systems

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled to undergo dual arch fixed appliance orthodontic treatment in any of the three trial centers will be invited to participate in this trial by the operator planning to conduct their orthodontic treatment.

Exclusion Criteria

* Patients who have undergone previous orthodontic treatment including fixed, removable and functional appliances.
* Patients less than 12 years old at the start of orthodontic treatment.
* Patients with orofacial clefting, severe hypodontia, and special needs patients.
* Patients undergoing orthognathic (jaw) surgery as part of their orthodontic treatment plan.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No