Contact information
Type
Scientific
Primary contact
Prof Robert T Lee
ORCID ID
Contact details
Orthodontics
Dental Institute
New Road
Whitechapel
London
E1 1BB
United Kingdom
+44 020 7377 7397
r.t.lee@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0205186777
Study information
Scientific title
Acronym
Study hypothesis
In the UK most orthodontic treatment is carried out using fixed appliances or 'braces'. The first phase of fixed appliance orthodontic treatment is concerned principally with tooth alignment. Conventional fixed orthodontic brackets are cemented onto the teeth and attached to an arch wire using elastic ligatures. The teeth are then aligned using forces generated by the arch wire itself. Recently a ligature-free bracket system has been introduced. It has been suggested that reduced friction associated with this system can provide considerable benefits to the patient, principally because the teeth align more rapidly. We propose to investigate the nature of alignment of two fixed orthodontic bracket systems: Smart-Clip self ligating and Ormco Synthesis conventional siamese.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Oral Health: Orthodontics
Intervention
Smart-Clip® ligature free brackets vs conventional pre-adjusted edgewise brackets (3M Unitek).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The ability of two fixed appliance orthodontic bracket systems to align crowded lower incisors. In particular lower incisor inclination and arch form changes will be compared.
Null hypothesis: there is no difference in lower incisor inclination, and angulation, and lower arch dimensions using self-ligating and conventional pre-adjusted edgewise brackets.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
22/09/2006
Overall trial end date
21/05/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients should be fit and well and not currently on any medication or suffering from any craniofacial syndrome. Medication could theoretically affect the connective tissues that remodel during orthodontic treatment
2. Children under 18 years
3. Lower incisor tooth crowding of up to 5mm as part of their malocclusion
4. A requirement for fixed orthodontic treatment on a non-extraction basis
5. More severely crowded dentitions often require the loss of premolar teeth to provide the necessary space for alignment of the dental arch
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
20
Participant exclusion criteria
1. A complete overbite. Complete overbite might be expected to reduce rates of tooth alignment due to bracket interferences.
2. No incisor teeth completely excluded from the dental arch
Recruitment start date
22/09/2006
Recruitment end date
21/05/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Orthodontics
London
E1 1BB
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Barts and The London NHS Trust (UK), NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19409342
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19732667
Publication citations
-
Results
Fleming PS, DiBiase AT, Sarri G, Lee RT, Efficiency of mandibular arch alignment with 2 preadjusted edgewise appliances., Am J Orthod Dentofacial Orthop, 2009, 135, 5, 597-602, doi: 10.1016/j.ajodo.2007.06.014.
-
Results
Fleming PS, DiBiase AT, Sarri G, Lee RT, Comparison of mandibular arch changes during alignment and leveling with 2 preadjusted edgewise appliances., Am J Orthod Dentofacial Orthop, 2009, 136, 3, 340-347, doi: 10.1016/j.ajodo.2007.08.030.