Condition category
Oral Health
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
06/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr VS Lucas

ORCID ID

Contact details

Oral Surgery Department
Eastman Dental Hospital
256 Gray's Inn Road
London
WC1X 8LD
United Kingdom
+44 (0)20 7915 1000

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes