A prospective randomized trial investigating the alignment efficiency of two pre-adjusted edgewise orthodontic bracket systems

ISRCTN	ISRCTN66185030
DOI	https://doi.org/10.1186/ISRCTN66185030
Protocol serial number	N0013154732
Sponsor	Department of Health
Funders	Guy's and St. Thomas' NHS Foundation Trust (UK), Own account, NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Martyn Cobourne
Scientific

Department of Orthodontics
F22 Guy's Tower
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom

Phone	+44 (0)20 7188 4432
Email	martyn.cobourne@kcl.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Speed of alignment of the lower labial segment 2. Self reported pain or discomfort and root resorption of lower central incisors
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/11/2006

Participant type(s)	Patient
Age group	Child
Upper age limit	16 Years
Sex	Not Specified
Target sample size at registration	60
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	08/11/2004
Date of final enrolment	30/11/2006

Department of Orthodontics

London
SE1 9RT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2008		Yes	No