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0.018 or 0.022 Bracket Slot System More Effective in Orthodontic Treatment? (18v22)

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ClinicalTrials.gov Identifier: NCT02080338
Recruitment Status : Completed
First Posted : March 6, 2014
Last Update Posted : June 28, 2018
Sponsor:
Collaborator:
NHS Research and Development
Information provided by (Responsible Party):
David Bearn, University of Dundee

Brief Summary:
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 .

Condition or disease Intervention/treatment Phase
Malocclusion Device: Orthodontic bracket slot system Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is the 0.018-inch or the 0.022-inch Bracket Slot System More Effective in Orthodontic Treatment? A Randomized Clinical Trial.
Actual Study Start Date : January 2010
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

Arm Intervention/treatment
Experimental: 0.018 bracket slot system
Participants treated using 0.018-inch orthodontic bracket slot system
Device: Orthodontic bracket slot system
Orthodontic treatment using different orthodontic bracket slot systems

Active Comparator: 0.022 bracket slot system
Participants treated using 0.022-inch orthodontic bracket slot system
Device: Orthodontic bracket slot system
Orthodontic treatment using different orthodontic bracket slot systems




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02080338


Locations
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United Kingdom
Springfield Medical Center
Arbroath, United Kingdom, DD11 1ES
Dundee Dental Hospital
Dundee, United Kingdom, DD1 4HN
Perth Royal Infirmary
Perth, United Kingdom, PH1 1NX
Sponsors and Collaborators
David Bearn
NHS Research and Development
Investigators
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Principal Investigator: Ahmed M El-Angbawi, PhD University of Dundee
Study Chair: David R Bearn, Prof University of Dundee

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Bearn, Professor of Orthodontics, University of Dundee
ClinicalTrials.gov Identifier: NCT02080338     History of Changes
Other Study ID Numbers: 20092E07
09/S1401/56 ( Registry Identifier: East of Scotland Research Ethics Service )
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018

Keywords provided by David Bearn, University of Dundee:
Orthodontic, Bracket slot, Effective, Randomized, Duration

Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases