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Completed

NCT Number: NCT02080338

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

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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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Springfield Medical Center, Arbroath, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Orthodontic bracket slot system

Device

Orthodontic treatment using different orthodontic bracket slot systems

Primary outcomes

  1. Duration of fixed appliance orthodontic treatment

    Time frame: Completion of orthodontic treatment, an expected average of 24 months.

    Number of months in orthodontic treatment from the start of fitting the fixed orthodontic appliance until the removal of the fixed appliance.

Secondary outcomes

  1. Occlusal treatment outcome

    Time frame: The ooclusal outcome will be assessed at the end of orthodontic treatment, an average of 24 months.

    The quality of the treatment result will principally be measured by assessing the occlusal outcome using the Peer Assessment Rating Index (PAR Index) from study models recorded at the start and end of treatment (average 24 months).

Other outcomes

  1. Biological side effect of fixed appliance orthodontic treatment

    Time frame: At 9 months from the start of treatment

    The amount of orthodontically induced inflammatory root resorption (OIIRR) will be investigated from periapical radiographs recorded at 9 months into active treatment.

  2. Patient perception of wearing the fixed appliance

    Time frame: At six months from start of treatment

    Patient perception of wearing the fixed orthodontic appliance will be recorded using a questionnaire (Smiles Better) at 6 months from the start of treatment.

  3. Patient perception of the of fixed appliance treatment outcome

    Time frame: Following the end of orthodontic treatment , an average of 24 months.

    Patient perception of the of fixed appliance treatment outcome, by comparing patient questionnaire pre-treatment and after treatment (average of 24 months).

Sponsors and collaborators

Lead sponsor

David Bearn

Other

Collaborators

  • NHS Research and Development

Registry information

Official study title

Is the 0.018-inch or the 0.022-inch Bracket Slot System More Effective in Orthodontic Treatment? A Randomized Clinical Trial.

Acronym: 18v22

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Mar 6, 2014
Registry last updated
Jun 28, 2018

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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