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| Name | Class |
|---|---|
| East Kent Hospitals University NHS Foundation Trust | OTHER_GOV |
| Southend NHS Foundation Trust | OTHER |
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This is a clinical study involving patients undergoing orthodontic treatment with fixed appliances ('train-track braces'). A new type of train-track has recently been marketed. Over 4 million patients worldwide are wearing on of these appliances; this system is considerably more expensive than a normal train-track. However, there is little evidence to support its use.
The effects of three different types of train-track will be assessed with respect to the quality of Orthodontic tooth movement produced. Furthermore, the impact of the different train-tracks on daily life of orthodontic patients will also be measured. Consequently, the investigators will be able to inform orthodontists' decisions relating to the choice of train-track they recommend for their patients. In addition, should the more expensive appliances demonstrate objective or subjective advantage, a significant efficiency saving may develop.
This is a clinical study involving patients undergoing orthodontic treatment with fixed appliances ('train-track braces'). A new type of train-track has recently been marketed. Over 4 million patients worldwide are wearing on of these appliances; this system is considerably more expensive than a normal train-track. However, there is little evidence to support its use.
The effects of three different types of train-track will be assessed in this clinical trial with respect to the quality of Orthodontic tooth movement produced. Furthermore, the impact of the different train-tracks on daily life of orthodontic patients will also be measured. Consequently, the investigators will be able to inform orthodontists' decisions relating to the choice of train-track they recommend for their patients. In addition, should the more expensive appliances demonstrate objective or subjective advantage, a significant efficiency saving may develop.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InOvation C | Active Comparator | Active Self-ligating Bracket |
|
| Ovation | Placebo Comparator | Conventional Bracket |
|
| Damon Q | Experimental | Self-ligating bracket |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket | Device | Subjects randomized to treatment with one of three fixed orthodontic appliances: Damon Q, InOvation C and Ovation brackets. A pre-determined archwire sequence will be used involving round nickel titanium, rectangular nickel titanium progressing to 0.019 X 0.025 inch stainless steel; specific archwire sequences and appointment intervals will be based on the manufacturer's guidelines. All erupted teeth will have attachments placed from the outset. Treated for a minimum of 8 months with the 0.019 X 0.025 inch stainless steel archwire in place for at least 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Transverse dimensional changes and bucco-lingual inclination changes | Width in mm | 3 years 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective pain experience | Pain score | 3 years 10 months |
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Inclusion Criteria:
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Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Robert t Lee, MDS | Royal London Dental Institute | Principal Investigator |
| Ama Johal, PhD | QMUL | Study Director |
| Valeria Marinho, PhD | QMUL | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Kent Hospitals NHS Foundation Trust | Canterbury | Kent | CT1 3NG | United Kingdom | ||
| Royal London Dental Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23910199 | Derived | Fleming PS, Lee RT, Marinho V, Johal A. Comparison of maxillary arch dimensional changes with passive and active self-ligation and conventional brackets in the permanent dentition: a multicenter, randomized controlled trial. Am J Orthod Dentofacial Orthop. 2013 Aug;144(2):185-93. doi: 10.1016/j.ajodo.2013.03.012. |
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|
| London |
| E1 1BB |
| United Kingdom |