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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.

El-Angbawi AM, Bearn DR, McIntyre GT - Trials (2014)

Bottom Line: Both systems are used by clinicians worldwide with some orthodontists claiming the superiority and clinical advantages 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 clinical preference.

View Article: PubMed Central - PubMed

Affiliation: Dundee Dental Hospital & School, Park Place, University of Dundee, Dundee DD1 4HN, UK. a.elangbawi@dundee.ac.uk.

ABSTRACT

Background: Edgewise fixed orthodontic appliances are available in two different bracket slot sizes (0.018 and 0.022 inch). Both systems are used by clinicians worldwide with some orthodontists claiming the superiority and clinical advantages 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 clinical preference. We aim to compare the 0.018-inch and 0.022-inch pre-adjusted bracket slot systems in terms of the effectiveness of orthodontic treatment.

Methods/design: This is a prospective, multicenter, randomized clinical trial, undertaken in the secondary care hospital environment in the NHS Tayside region of Scotland (United Kingdom). A total of 216 orthodontic patients will be recruited in three centers in secondary care hospitals in NHS Tayside. 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 series™ conventional pre-adjusted bracket systems (3 M Unitek, Monrovia, United States). Baseline records and outcome data collected during and at the end of orthodontic treatment will be assessed. The primary outcome measures will be the duration of orthodontic treatment in the maxillary and mandibular arches. The secondary outcome measures will be the number of scheduled appointments for orthodontic treatment in the maxillary and mandibular arches, treatment outcome using Peer Assessment Rating index (PAR), orthodontically induced inflammatory root resorption (as measured using periapical radiographs) and the patient's perception of wearing orthodontic appliances.

Discussion: The results from the current study will serve as evidence to guide the clinician in deciding whether the difference in bracket slot size has a significant impact on the effectiveness of orthodontic treatment.

Trial registration: Registered with ClinicalTrials.gov on 5 March 2014, registration number: NCT02080338.

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Related in: MedlinePlus

Trial CONSORT flow chart with projected numbers of participants throughout the trial. Intervention 1: 0.018-inch bracket slot system and intervention 2: 0.022-inch bracket slot system.
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Fig1: Trial CONSORT flow chart with projected numbers of participants throughout the trial. Intervention 1: 0.018-inch bracket slot system and intervention 2: 0.022-inch bracket slot system.

Mentions: The current trial is a multicenter, two-arm, parallel group, randomized controlled trial (Figure 1) designed following the CONSORT guidelines [10]. Patients who give informed consent to participate in this study will be entered into the study database, which will be held on one of the computers within the Orthodontic Department at Dundee Dental Hospital and School. Each participating patient will be allocated the next available study number at the start of active treatment using a series of opaque envelopes containing the treatment group.Figure 1


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.

El-Angbawi AM, Bearn DR, McIntyre GT - Trials (2014)

Trial CONSORT flow chart with projected numbers of participants throughout the trial. Intervention 1: 0.018-inch bracket slot system and intervention 2: 0.022-inch bracket slot system.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4197276&req=5

Fig1: Trial CONSORT flow chart with projected numbers of participants throughout the trial. Intervention 1: 0.018-inch bracket slot system and intervention 2: 0.022-inch bracket slot system.
Mentions: The current trial is a multicenter, two-arm, parallel group, randomized controlled trial (Figure 1) designed following the CONSORT guidelines [10]. Patients who give informed consent to participate in this study will be entered into the study database, which will be held on one of the computers within the Orthodontic Department at Dundee Dental Hospital and School. Each participating patient will be allocated the next available study number at the start of active treatment using a series of opaque envelopes containing the treatment group.Figure 1

Bottom Line: Both systems are used by clinicians worldwide with some orthodontists claiming the superiority and clinical advantages 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 clinical preference.

View Article: PubMed Central - PubMed

Affiliation: Dundee Dental Hospital & School, Park Place, University of Dundee, Dundee DD1 4HN, UK. a.elangbawi@dundee.ac.uk.

ABSTRACT

Background: Edgewise fixed orthodontic appliances are available in two different bracket slot sizes (0.018 and 0.022 inch). Both systems are used by clinicians worldwide with some orthodontists claiming the superiority and clinical advantages 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 clinical preference. We aim to compare the 0.018-inch and 0.022-inch pre-adjusted bracket slot systems in terms of the effectiveness of orthodontic treatment.

Methods/design: This is a prospective, multicenter, randomized clinical trial, undertaken in the secondary care hospital environment in the NHS Tayside region of Scotland (United Kingdom). A total of 216 orthodontic patients will be recruited in three centers in secondary care hospitals in NHS Tayside. 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 series™ conventional pre-adjusted bracket systems (3 M Unitek, Monrovia, United States). Baseline records and outcome data collected during and at the end of orthodontic treatment will be assessed. The primary outcome measures will be the duration of orthodontic treatment in the maxillary and mandibular arches. The secondary outcome measures will be the number of scheduled appointments for orthodontic treatment in the maxillary and mandibular arches, treatment outcome using Peer Assessment Rating index (PAR), orthodontically induced inflammatory root resorption (as measured using periapical radiographs) and the patient's perception of wearing orthodontic appliances.

Discussion: The results from the current study will serve as evidence to guide the clinician in deciding whether the difference in bracket slot size has a significant impact on the effectiveness of orthodontic treatment.

Trial registration: Registered with ClinicalTrials.gov on 5 March 2014, registration number: NCT02080338.

Show MeSH
Related in: MedlinePlus