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| ID | Type | Description | Link |
|---|---|---|---|
| 09/S1401/56 | Registry Identifier | East of Scotland Research Ethics Service |
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| Name | Class |
|---|---|
| NHS Research and Development | OTHER_GOV |
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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 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.018 bracket slot system | Experimental | Participants treated using 0.018-inch orthodontic bracket slot system |
|
| 0.022 bracket slot system | Active Comparator | Participants treated using 0.022-inch orthodontic bracket slot system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthodontic bracket slot system | Device | Orthodontic treatment using different orthodontic bracket slot systems |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patient perception of wearing the fixed appliance |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed M El-Angbawi, PhD | University of Dundee | Principal Investigator |
| David R Bearn, Prof | University of Dundee | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Springfield Medical Center | Arbroath | DD11 1ES | United Kingdom | |||
| Dundee Dental Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30007333 | Derived | 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. | |
| 30007330 | Derived | 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. |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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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 |
| 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. |
| Dundee |
| DD1 4HN |
| United Kingdom |
| Perth Royal Infirmary | Perth | PH1 1NX | United Kingdom |
| 30007300 | Derived | 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. |
| 25288125 | Derived | 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. |