A Clinical Trial of Three Fixed Orthodontic Appliances

NCT01320657 | Completed DMC

• 1 other identifier: 2
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

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.

Conditions

Orthodontic Treatment

Keywords

Self-ligating; orthodontic; appliance; expansion; dental inclination; Expansion and inclination changes

Outcome Measures

Primary Outcomes (1)

• Transverse dimensional changes and bucco-lingual inclination changes

  Width in mm

  3 years 10 months

Secondary Outcomes (1)

• Subjective pain experience

  3 years 10 months

Study Arms (3)

InOvation C

ACTIVE COMPARATOR

Active Self-ligating Bracket

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

Ovation

PLACEBO COMPARATOR

Conventional Bracket

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

Damon Q

EXPERIMENTAL

Self-ligating bracket

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

Interventions

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.

Damon Q; InOvation C; Ovation

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Subjects considered suitable for non-extraction maxillary arch treatment if not undergoing combined orthodontic-surgical treatment;
• Crowding less than 6mm

You may not qualify if:

• Cleft lip and palate and other craniofacial anomalies.

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• East Kent Hospitals University NHS Foundation Trust: collaborator
• Southend NHS Foundation Trust: collaborator

Study Sites (2)

East Kent Hospitals NHS Foundation Trust

Canterbury, Kent, CT1 3NG, United Kingdom

Location

Royal London Dental Institute

London, E1 1BB, United Kingdom

Location

Related Publications (1)

• Fleming PS, Lee RT, Marinho V, Johal A. Comparison of maxillary arch dimensional changes with passive and active self-ligation and conventional brackets in the permanent dentition: a multicenter, randomized controlled trial. Am J Orthod Dentofacial Orthop. 2013 Aug;144(2):185-93. doi: 10.1016/j.ajodo.2013.03.012.

  PMID: 23910199 DERIVED

Study Officials

• Robert t Lee, MDS

  Royal London Dental Institute

  PRINCIPAL INVESTIGATOR

• Ama Johal, PhD

  QMUL

  STUDY DIRECTOR

• Valeria Marinho, PhD

  QMUL

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: March 22, 2011
• Study Start: August 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: May 1, 2013
• Last Updated: December 22, 2022

Record last verified: 2012-04

Locations

GB (2)