Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0263092953
Study information
Scientific title
Acronym
Study hypothesis
There may be an increase in the prevalence and intensity of bacteraemia following either debanding or gold chain adjustment, compared with baseline.
Ethics approval
Not provided at time of registration
Study design
Randomised single blind study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Oral Health: Orthodontics
Intervention
1. Debanding
2. Adjustment of a gold chain and bracket
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Prevalence of bacteraemia (number of positive blood cultures)
2. Intensity of bacteraemia (number of colony forming units of bacteria per ml blood)
3. Identity of bacteria isolated from blood cultures
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/2002
Overall trial end date
01/09/2003
Reason abandoned
Eligibility
Participant inclusion criteria
82 patients from Paediatric Dentistry.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
82
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/12/2002
Recruitment end date
01/09/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oral Surgery Department
London
WC1X 8LD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
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
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17317865
Publication citations
-
Results
Lucas VS, Kyriazidou A, Gelbier M, Roberts GJ, Bacteraemia following debanding and gold chain adjustment., Eur J Orthod, 2007, 29, 2, 161-165, doi: 10.1093/ejo/cjl085.