A Clinical Trial of Three Fixed Orthodontic Appliances

Barts & The London NHS Trust

Status: Completed

Conditions: Orthodontic Treatment

Treatments: Device: Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket

Study type: Interventional

Funder types: Other

Identifiers

NCT01320657

2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 3 patient groups, including a placebo group

InOvation C

Active Comparator group

Description:

Active Self-ligating Bracket

Treatment:

Device: Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket

Ovation

Placebo Comparator group

Description:

Conventional Bracket

Treatment:

Device: Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket

Damon Q

Experimental group

Description:

Self-ligating bracket

Treatment:

Device: Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket