A Clinical Trial of Three Fixed Orthodontic Appliances

Orthodontic Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320657
• Other study ID #: 2
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Est. completion date: May 2013

Study information

• Verified date: April 2012
• Source: Barts & The London NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 in this clinical trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Orthodontic Treatment

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	East Kent Hospitals NHS Foundation Trust	Canterbury	Kent
United Kingdom	Royal London Dental Institute	London

Sponsors (3)

Lead Sponsor	Collaborator
Barts & The London NHS Trust	East Kent Hospitals University NHS Foundation Trust, Southend NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transverse dimensional changes and bucco-lingual inclination changes	Width in mm	3 years 10 months
Secondary	Subjective pain experience	Pain score	3 years 10 months