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Completed

NCT Number: NCT01320657

A Clinical Trial of Three Fixed Orthodontic Appliances

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.

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Key information

Conditions

Orthodontic Treatment

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Kent Hospitals NHS Foundation Trust, Canterbury, Kent, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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 outcomes

  1. Transverse dimensional changes and bucco-lingual inclination changes

    Time frame: 3 years 10 months

    Width in mm

Secondary outcomes

  1. Subjective pain experience

    Time frame: 3 years 10 months

    Pain score

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Collaborators

  • East Kent Hospitals University NHS Foundation Trust
  • Southend NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Mar 22, 2011
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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