Condition category
Oral Health
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
26/02/2016
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 A Ireland

ORCID ID

Contact details

C/O Research & Effectiveness Department
Level 1
The Old Building
Bristol Royal Infirmary
Malborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 928 3473
r&eoffice@ubht.swest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0264149440

Study information

Scientific title

Application of molecular diagnostic methodologies to analyse plaque microbial population shifts associated with placement of fixed orthodontic appliances

Acronym

Study hypothesis

Are there shifts from non-pathological to pathological bacterial flora following the placement of fixed orthodontic appliances (braces)

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

Other

Trial type

Other

Patient information sheet

Condition

Oral Health: Orthodontics

Intervention

Placement of fixed appliances (braces) - randomised cross mouth allocation of bands

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Changes in the oral microflora, both sub and supra gingival, as a result of orthodontic fixed appliance treatment (braces).

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2005

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

25 patients aged 11-14 years about to start treatment with fixed orthodontic appliances

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

25

Participant exclusion criteria

1. Patients requiring dental arch expansion
2. Heavily restored dentition
3. Use of antibiotics in the last 3 months

Recruitment start date

01/01/2005

Recruitment end date

01/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

C/O Research & Effectiveness Department
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

United Bristol Healthcare NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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

26/02/2016: No publications found, verifying study status with principal investigator