Clinical trial NCT02080338: 0.018 or 0.022 Bracket Slot System More Effective in Orthodontic Treatment?
Official title: Is the 0.018-inch or the 0.022-inch Bracket Slot System More Effective in Orthodontic Treatment? A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Keywords: Orthodontic, Bracket slot, Effective, Randomized, Duration
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: NHS Research and Development
First posted: 2014-03-06
Enrollment: 187
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of fixed appliance orthodontic treatment
timeFrame: Completion of orthodontic treatment, an expected average of 24 months.
Secondary outcomes:
measure: Occlusal treatment outcome
timeFrame: The ooclusal outcome will be assessed at the end of orthodontic treatment, an average of 24 months.
Other outcomes:
measure: Biological side effect of fixed appliance orthodontic treatment
timeFrame: At 9 months from the start of treatment
measure: Patient perception of wearing the fixed appliance
timeFrame: At six months from start of treatment
measure: Patient perception of the of fixed appliance treatment outcome
timeFrame: Following the end of orthodontic treatment , an average of 24 months.
Locations:
city: Arbroath
country: United Kingdom
facility: Springfield Medical Center
city: Dundee
country: United Kingdom
facility: Dundee Dental Hospital
city: Perth
country: United Kingdom
facility: Perth Royal Infirmary
Study officials:
affiliation: University of Dundee
name: Ahmed M El-Angbawi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dundee
name: David R Bearn, Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.