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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 2, 2014
First Posted Date  ICMJE March 6, 2014
Last Update Posted Date June 28, 2018
Actual Study Start Date  ICMJE January 2010
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 4, 2014)
  • 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.
  • 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.
  • 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).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE 0.018 or 0.022 Bracket Slot System More Effective in Orthodontic Treatment?
Official Title  ICMJE Is the 0.018-inch or the 0.022-inch Bracket Slot System More Effective in Orthodontic Treatment? A Randomized Clinical Trial.
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 .
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Malocclusion
Intervention  ICMJE Device: Orthodontic bracket slot system
Orthodontic treatment using different orthodontic bracket slot systems
Study Arms  ICMJE
  • Experimental: 0.018 bracket slot system
    Participants treated using 0.018-inch orthodontic bracket slot system
    Intervention: Device: Orthodontic bracket slot system
  • Active Comparator: 0.022 bracket slot system
    Participants treated using 0.022-inch orthodontic bracket slot system
    Intervention: Device: Orthodontic bracket slot system
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2018)
187
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2014)
216
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02080338
Other Study ID Numbers  ICMJE 20092E07
09/S1401/56 ( Registry Identifier: East of Scotland Research Ethics Service )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Bearn, University of Dundee
Study Sponsor  ICMJE David Bearn
Collaborators  ICMJE NHS Research and Development
Investigators  ICMJE
Principal Investigator: Ahmed M El-Angbawi, PhD University of Dundee
Study Chair: David R Bearn, Prof University of Dundee
PRS Account University of Dundee
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP