Malocclusion
Conditions
Keywords
Orthodontic, Bracket slot, Effective, Randomized, Duration
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.
Interventions
DEVICEOrthodontic bracket slot system
Orthodontic treatment using different orthodontic bracket slot systems
Sponsors
NHS Research and Development
David Bearn
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of fixed appliance orthodontic treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occlusal treatment outcome | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biological side effect of fixed appliance orthodontic treatment | 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 | 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 | 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). |
Countries
United Kingdom
Outcome results
None listed