Clinical Trials Directory

Trials / Completed

CompletedNCT02080338

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
187 (actual)
Sponsor
David Bearn · Academic / Other
Sex
All
Age
12 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEOrthodontic bracket slot systemOrthodontic treatment using different orthodontic bracket slot systems

Timeline

Start date
2010-01-01
Primary completion
2017-03-01
Completion
2017-03-01
First posted
2014-03-06
Last updated
2018-06-28

Locations

3 sites across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT02080338. Inclusion in this directory is not an endorsement.