Orthodontic Treatment
Conditions
Keywords
Self-ligating, orthodontic, appliance, expansion, dental inclination, Expansion and inclination changes
Brief summary
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.
Detailed description
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.
Interventions
DEVICEConventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket
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.
Sponsors
East Kent Hospitals University NHS Foundation Trust
Southend NHS Foundation Trust
Barts & The London NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Young adults aged 16 years and over; * Fit and well and on no medication; * In the permanent dentition; * Undergoing orthodontic treatment in preparation for combined orthodontic-surgical care or * Subjects considered suitable for non-extraction maxillary arch treatment if not undergoing combined orthodontic-surgical treatment; * Crowding less than 6mm
Exclusion criteria
* Cleft lip and palate and other craniofacial anomalies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transverse dimensional changes and bucco-lingual inclination changes | 3 years 10 months | Width in mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective pain experience | 3 years 10 months | Pain score |
Countries
United Kingdom
Outcome results
None listed