0.018 or 0.022 Bracket Slot System More Effective in Orthodontic Treatment? (18v22)
Primary Purpose
Malocclusion
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Orthodontic bracket slot system
Sponsored by
About this trial
This is an interventional treatment trial for Malocclusion focused on measuring Orthodontic, Bracket slot, Effective, Randomized, Duration
Eligibility 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.
Sites / Locations
- Springfield Medical Center
- Dundee Dental Hospital
- Perth Royal Infirmary
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
0.018 bracket slot system
0.022 bracket slot system
Arm Description
Participants treated using 0.018-inch orthodontic bracket slot system
Participants treated using 0.022-inch orthodontic bracket slot system
Outcomes
Primary Outcome Measures
Duration of fixed appliance orthodontic treatment
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
Occlusal treatment outcome
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).
Full Information
NCT ID
NCT02080338
First Posted
March 2, 2014
Last Updated
June 26, 2018
Sponsor
David Bearn
Collaborators
NHS Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02080338
Brief Title
0.018 or 0.022 Bracket Slot System More Effective in Orthodontic Treatment?
Acronym
18v22
Official Title
Is the 0.018-inch or the 0.022-inch Bracket Slot System More Effective in Orthodontic Treatment? A Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 2010 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Bearn
Collaborators
NHS Research and Development
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
Orthodontic, Bracket slot, Effective, Randomized, Duration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.018 bracket slot system
Arm Type
Experimental
Arm Description
Participants treated using 0.018-inch orthodontic bracket slot system
Arm Title
0.022 bracket slot system
Arm Type
Active Comparator
Arm Description
Participants treated using 0.022-inch orthodontic bracket slot system
Intervention Type
Device
Intervention Name(s)
Orthodontic bracket slot system
Intervention Description
Orthodontic treatment using different orthodontic bracket slot systems
Primary Outcome Measure Information:
Title
Duration of fixed appliance orthodontic treatment
Description
Number of months in orthodontic treatment from the start of fitting the fixed orthodontic appliance until the removal of the fixed appliance.
Time Frame
Completion of orthodontic treatment, an expected average of 24 months.
Secondary Outcome Measure Information:
Title
Occlusal treatment outcome
Description
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).
Time Frame
The ooclusal outcome will be assessed at the end of orthodontic treatment, an average of 24 months.
Other Pre-specified Outcome Measures:
Title
Biological side effect of fixed appliance orthodontic treatment
Description
The amount of orthodontically induced inflammatory root resorption (OIIRR) will be investigated from periapical radiographs recorded at 9 months into active treatment.
Time Frame
At 9 months from the start of treatment
Title
Patient perception of wearing the fixed appliance
Description
Patient perception of wearing the fixed orthodontic appliance will be recorded using a questionnaire (Smiles Better) at 6 months from the start of treatment.
Time Frame
At six months from start of treatment
Title
Patient perception of the of fixed appliance treatment outcome
Description
Patient perception of the of fixed appliance treatment outcome, by comparing patient questionnaire pre-treatment and after treatment (average of 24 months).
Time Frame
Following the end of orthodontic treatment , an average of 24 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M El-Angbawi, PhD
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David R Bearn, Prof
Organizational Affiliation
University of Dundee
Official's Role
Study Chair
Facility Information:
Facility Name
Springfield Medical Center
City
Arbroath
ZIP/Postal Code
DD11 1ES
Country
United Kingdom
Facility Name
Dundee Dental Hospital
City
Dundee
ZIP/Postal Code
DD1 4HN
Country
United Kingdom
Facility Name
Perth Royal Infirmary
City
Perth
ZIP/Postal Code
PH1 1NX
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
30007333
Citation
Yassir YA, El-Angbawi AM, McIntyre GT, Revie GF, Bearn DR. A randomized clinical trial of the effectiveness of 0.018-inch and 0.022-inch slot orthodontic bracket systems: part 2-quality of treatment. Eur J Orthod. 2019 Mar 29;41(2):143-153. doi: 10.1093/ejo/cjy038.
Results Reference
derived
PubMed Identifier
30007330
Citation
El-Angbawi AM, Yassir YA, McIntyre GT, Revie GF, Bearn DR. A randomized clinical trial of the effectiveness of 0.018-inch and 0.022-inch slot orthodontic bracket systems: part 3-biological side-effects of treatment. Eur J Orthod. 2019 Mar 29;41(2):154-164. doi: 10.1093/ejo/cjy039.
Results Reference
derived
PubMed Identifier
30007300
Citation
Yassir YA, El-Angbawi AM, McIntyre GT, Revie GF, Bearn DR. A randomized clinical trial of the effectiveness of 0.018-inch and 0.022-inch slot orthodontic bracket systems: part 1-duration of treatment. Eur J Orthod. 2019 Mar 29;41(2):133-142. doi: 10.1093/ejo/cjy037.
Results Reference
derived
PubMed Identifier
25288125
Citation
El-Angbawi AM, Bearn DR, McIntyre GT. Comparing the effectiveness of the 0.018-inch versus the 0.022-inch bracket slot system in orthodontic treatment: study protocol for a randomized controlled trial. Trials. 2014 Oct 6;15:389. doi: 10.1186/1745-6215-15-389.
Results Reference
derived
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0.018 or 0.022 Bracket Slot System More Effective in Orthodontic Treatment?
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