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A Clinical Trial of Three Fixed Orthodontic Appliances

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ClinicalTrials.gov Identifier: NCT01320657
Recruitment Status : Unknown
Verified April 2012 by Barts & The London NHS Trust.
Recruitment status was:  Active, not recruiting
First Posted : March 22, 2011
Last Update Posted : April 13, 2012
Sponsor:
Collaborators:
East Kent Hospitals University NHS Foundation Trust
Southend NHS Foundation Trust
Information provided by (Responsible Party):
Barts & The London NHS Trust

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.


Condition or disease Intervention/treatment Phase
Orthodontic Treatment Device: Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Randomised Clinical Trial of Orthodontic Treatment With 3 Fixed Appliance Systems Assessed Using Digital Models
Study Start Date : August 2009
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. Transverse dimensional changes and bucco-lingual inclination changes [ Time Frame: 3 years 10 months ]

Secondary Outcome Measures :
  1. Subjective pain experience [ Time Frame: 3 years 10 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: April 13, 2012
Last Verified: April 2012

Keywords provided by Barts & The London NHS Trust:
Self-ligating
orthodontic
appliance
expansion
dental inclination
Expansion and inclination changes arising with orthodontic treatment