Condition category
Oral Health
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
28/02/2014
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

Miss Samantha Hodge

ORCID ID

Contact details

Department of Orthodontics
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

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes