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

Malocclusion Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080338
• Other study ID #: 20092E07
• Secondary ID: 09/S1401/56
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: March 2017

Study information

• Verified date: June 2018
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malocclusion

Intervention

Device:
• Orthodontic bracket slot system
Orthodontic treatment using different orthodontic bracket slot systems

Locations

Country	Name	City	State
United Kingdom	Springfield Medical Center	Arbroath
United Kingdom	Dundee Dental Hospital	Dundee
United Kingdom	Perth Royal Infirmary	Perth

Sponsors (2)

Lead Sponsor	Collaborator
David Bearn	NHS Research and Development

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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.
Primary	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	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.