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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 30, 2014