Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0263139746
Study information
Scientific title
Acronym
Study hypothesis
To determine the failure rate and survival time of orthodontic bands cemented with a fluoride releasing, non-primer step required, no mix composite compared with a conventional no-mix composite and if there is a difference in demineralisation.
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
Treatment
Patient information sheet
Condition
Oral Health: Orthodontics
Intervention
1. Fluoride releasing, non-primer step required, no mix composite
2. Conventional no mix composite
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The site and time to bond failure to be recorded for each bracket that fails over a six month period (in the first instance) and then up to the completion of treatment.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
17/03/2004
Overall trial end date
01/07/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50 patients from Orthodontics
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
17/03/2004
Recruitment end date
01/07/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Orthodontics
London
WC1X 8LD
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University College London Hospitals NHS Trust (UK)
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