A Clinical Trial of Three Fixed Orthodontic Appliances

This study is ongoing, but not recruiting participants.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 21, 2011

Last Updated Date

April 12, 2012

Start Date ^ICMJE

August 2009

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01320657 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Subjective pain experience [ Time Frame: 3 years 10 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Clinical Trial of Three Fixed Orthodontic Appliances

Official Title ^ICMJE

A Randomised Clinical Trial of Orthodontic Treatment With 3 Fixed Appliance Systems Assessed Using Digital Models

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Orthodontic Treatment

Intervention ^ICMJE

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.

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2013

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

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.

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01320657

Other Study ID Numbers ^ICMJE

Has Data Monitoring Committee

Yes

Responsible Party

Barts & The London NHS Trust

Study Sponsor ^ICMJE

Barts & The London NHS Trust

Collaborators ^ICMJE

East Kent Hospitals University NHS Foundation Trust
Southend NHS Foundation Trust

Investigators ^ICMJE

Principal Investigator:	Robert t Lee, MDS	Royal London Dental Institute
Study Director:	Ama Johal, PhD	QMUL
Study Director:	Valeria Marinho, PhD	QMUL

Information Provided By

Barts & The London NHS Trust

Verification Date

April 2012

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

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