Overview

This trial is active, not recruiting.

Condition orthodontic treatment
Treatment conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket
Sponsor Barts & The London NHS Trust
Collaborator East Kent Hospitals University NHS Foundation Trust
Start date August 2009
End date August 2012
Trial size 96 participants
Trial identifier NCT01320657, 2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Active Comparator)
Active Self-ligating Bracket
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.
(Placebo Comparator)
Conventional Bracket
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.
(Experimental)
Self-ligating bracket
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.

Primary Outcomes

Measure
Transverse dimensional changes and bucco-lingual inclination changes
time frame: 3 years 10 months

Secondary Outcomes

Measure
Subjective pain experience
time frame: 3 years 10 months

Eligibility Criteria

Male or female participants at least 16 years old.

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.

Additional Information

Official title A Randomised Clinical Trial of Orthodontic Treatment With 3 Fixed Appliance Systems Assessed Using Digital Models
Principal investigator Robert t Lee, MDS
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Barts & The London NHS Trust.