A Clinical Trial of Three Fixed Orthodontic Appliances
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Orthodontic Treatment |
Device: Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomised Clinical Trial of Orthodontic Treatment With 3 Fixed Appliance Systems Assessed Using Digital Models |
- Transverse dimensional changes and bucco-lingual inclination changes [ Time Frame: 3 years 10 months ] [ Designated as safety issue: No ]
- Subjective pain experience [ Time Frame: 3 years 10 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 96 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: InOvation C
Active Self-ligating Bracket
|
Device: Conventional 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. |
|
Placebo Comparator: Ovation
Conventional Bracket
|
Device: Conventional 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. |
|
Experimental: Damon Q
Self-ligating bracket
|
Device: Conventional 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. |
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations| United Kingdom | |
| East Kent Hospitals NHS Foundation Trust | |
| Canterbury, Kent, United Kingdom, CT1 3NG | |
| Royal London Dental Institute | |
| London, United Kingdom, E1 1BB | |
| Principal Investigator: | Robert t Lee, MDS | Royal London Dental Institute |
| Study Director: | Ama Johal, PhD | QMUL |
| Study Director: | Valeria Marinho, PhD | QMUL |
More Information
No publications provided
| Responsible Party: | Barts & The London NHS Trust |
| ClinicalTrials.gov Identifier: | NCT01320657 History of Changes |
| Other Study ID Numbers: | 2 |
| Study First Received: | March 21, 2011 |
| Last Updated: | April 12, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Barts & The London NHS Trust:
|
Self-ligating orthodontic appliance |
expansion dental inclination Expansion and inclination changes arising with orthodontic treatment |
ClinicalTrials.gov processed this record on May 19, 2013