Clinical trial NCT01320657: A Clinical Trial of Three Fixed Orthodontic Appliances
Official title: A Randomised Clinical Trial of Orthodontic Treatment With 3 Fixed Appliance Systems Assessed Using Digital Models
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Treatment
Keywords: Self-ligating
orthodontic
appliance
expansion
dental inclination
Expansion and inclination changes
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: East Kent Hospitals University NHS Foundation Trust
name: Southend NHS Foundation Trust
First posted: 2011-03-22
Enrollment: 96
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Transverse dimensional changes and bucco-lingual inclination changes
timeFrame: 3 years 10 months
Secondary outcomes:
measure: Subjective pain experience
timeFrame: 3 years 10 months
Other outcomes:
Locations:
city: Canterbury
country: United Kingdom
facility: East Kent Hospitals NHS Foundation Trust
state: Kent
city: London
country: United Kingdom
facility: Royal London Dental Institute
Study officials:
affiliation: Royal London Dental Institute
name: Robert t Lee, MDS
role: PRINCIPAL_INVESTIGATOR
affiliation: QMUL
name: Ama Johal, PhD
role: STUDY_DIRECTOR
affiliation: QMUL
name: Valeria Marinho, PhD
role: STUDY_DIRECTOR
References:
citation: 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.