A Clinical Trial of Three Fixed Orthodontic Appliances

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Barts & The London NHS Trust.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
East Kent Hospitals University NHS Foundation Trust
Southend NHS Foundation Trust
Information provided by (Responsible Party):
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT01320657
First received: March 21, 2011
Last updated: April 12, 2012
Last verified: April 2012

March 21, 2011
April 12, 2012
August 2009
August 2012   (final data collection date for primary outcome measure)
Transverse dimensional changes and bucco-lingual inclination changes [ Time Frame: 3 years 10 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01320657 on ClinicalTrials.gov Archive Site
Subjective pain experience [ Time Frame: 3 years 10 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Clinical Trial of Three Fixed Orthodontic Appliances
A Randomised Clinical Trial of Orthodontic Treatment With 3 Fixed Appliance Systems Assessed Using Digital Models

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Orthodontic Treatment
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.

  • Active Comparator: InOvation C
    Active Self-ligating Bracket
    Intervention: Device: Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket
  • Placebo Comparator: Ovation
    Conventional Bracket
    Intervention: Device: Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket
  • Experimental: Damon Q
    Self-ligating bracket
    Intervention: Device: Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
96
May 2013
August 2012   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01320657
2
Yes
Barts & The London NHS Trust
Barts & The London NHS Trust
  • East Kent Hospitals University NHS Foundation Trust
  • Southend NHS Foundation Trust
Principal Investigator: Robert t Lee, MDS Royal London Dental Institute
Study Director: Ama Johal, PhD QMUL
Study Director: Valeria Marinho, PhD QMUL
Barts & The London NHS Trust
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP