Contact information
Type
Scientific
Primary contact
Dr Martyn Cobourne
ORCID ID
Contact details
Department of Orthodontics
F22 Guy's Tower
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom
+44 (0)20 7188 4432
martyn.cobourne@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0013154732
Study information
Scientific title
Acronym
Study hypothesis
Recently a ligature free orthodontic 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 alignment rate of two fixed orthodontic vracked systems; Ormco Damon-2 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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Oral Health
Intervention
A Prospective Randomised Controlled Clinical Trial comparing Ormco Damon 2 ligature free bracket system and Ormco conventional pre-adjusted edgewise bracket system. The patients will be given a "pain diary " to complete and they will be reviewed six weekly. Patients will be randomly allocated to one of the two groups.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Speed of alignment of the lower labial segment
2. Self reported pain or discomfort and root resorption of lower central incisors
Secondary outcome measures
Not provided at time of registration
Overall trial start date
08/11/2004
Overall trial end date
30/11/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Children under the age of 16, fit and well and not taking any medication; who present with a crowded dentition that require extraction of first pre-molars and fixed appliance therapy. 30 patients at Guy's and 30 at Canterbury.
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
08/11/2004
Recruitment end date
30/11/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Orthodontics
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Guy's and St. Thomas' NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Own account
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
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
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18339656
Publication citations
-
Results
Scott P, Sherriff M, Dibiase AT, Cobourne MT, Perception of discomfort during initial orthodontic tooth alignment using a self-ligating or conventional bracket system: a randomized clinical trial., Eur J Orthod, 2008, 30, 3, 227-232, doi: 10.1093/ejo/cjm131.