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
  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

Resource links provided by NLM:


Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • Transverse dimensional changes and bucco-lingual inclination changes [ Time Frame: 3 years 10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320657

Locations
United Kingdom
East Kent Hospitals NHS Foundation Trust
Canterbury, Kent, United Kingdom, CT1 3NG
Royal London Dental Institute
London, United Kingdom, E1 1BB
Sponsors and Collaborators
Barts & The London NHS Trust
East Kent Hospitals University NHS Foundation Trust
Southend NHS Foundation Trust
Investigators
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 by Barts & The London NHS Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 April 17, 2014