A Clinical Trial of Three Fixed Orthodontic Appliances

Not Applicable

Completed

• Conditions: Orthodontic Treatment
• Interventions: Device: Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket

• Registration Number: NCT01320657
• Lead Sponsor: 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.

Detailed 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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2011-03-21
• Study First Submitted QC: 2011-03-21
• Study First Posted: 2011-03-22
• Status Verified: 2012-04
• Primary Completion: 2012-08
• Study Completion: 2013-05
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ovation	Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket	Conventional Bracket
InOvation C	Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket	Active Self-ligating Bracket
Damon Q	Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket	Self-ligating bracket

Primary Outcome Measures

Name	Time	Method
Transverse dimensional changes and bucco-lingual inclination changes	3 years 10 months	Width in mm

Secondary Outcome Measures

Name	Time	Method
Subjective pain experience	3 years 10 months	Pain score

Trial Locations

Locations (2)

East Kent Hospitals NHS Foundation Trust; 🇬🇧 Canterbury, Kent, United Kingdom

Royal London Dental Institute; 🇬🇧 London, United Kingdom