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

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

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 .

Study Overview

• Status: Completed
• Conditions: Malocclusion
• Intervention / Treatment: Device: Orthodontic bracket slot system

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: Interventional
• Enrollment (Actual): 187
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Arbroath, United Kingdom, DD11 1ES
    • Springfield Medical Center
  • Dundee, United Kingdom, DD1 4HN
    • Dundee Dental Hospital
  • Perth, United Kingdom, PH1 1NX
    • Perth Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Completion of orthodontic treatment, an expected average of 24 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	The ooclusal outcome will be assessed at the end of orthodontic treatment, an average of 24 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological side effect of fixed appliance orthodontic treatment	The amount of orthodontically induced inflammatory root resorption (OIIRR) will be investigated from periapical radiographs recorded at 9 months into active treatment.	At 9 months from the start of treatment
Patient perception of wearing the fixed appliance	Patient perception of wearing the fixed orthodontic appliance will be recorded using a questionnaire (Smiles Better) at 6 months from the start of treatment.	At six months from start of treatment
Patient perception of the of fixed appliance treatment outcome	Patient perception of the of fixed appliance treatment outcome, by comparing patient questionnaire pre-treatment and after treatment (average of 24 months).	Following the end of orthodontic treatment , an average of 24 months.

Collaborators and Investigators

• Sponsor: David Bearn
• Collaborators: NHS Research and Development
• Investigators: Principal Investigator: Ahmed M El-Angbawi, PhD, University of Dundee; Study Chair: David R Bearn, Prof, University of Dundee

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: March 2, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (Estimate): March 6, 2014

Study Record Updates

• Last Update Posted (Actual): June 28, 2018
• Last Update Submitted That Met QC Criteria: June 26, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Orthodontic, Bracket slot, Effective, Randomized, Duration
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: 20092E07; 09/S1401/56 (Registry Identifier: East of Scotland Research Ethics Service)