Condition category
Oral Health
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/03/2016
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

Mr DO Morris

ORCID ID

Contact details

Oral and Maxillo-facial Surgery
Chancellor Wing
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 206 3697
david.morris@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436121385

Study information

Scientific title

A randomised prospective clinical trial to compare two different methods of applying a new resin-reinforced chemically-cured "moisture-friendly" glass ionomer cement for the bonding of orthodontic brackets

Acronym

Study hypothesis

The study will be used to investigate the clinical failure rate, using the survival rate analysis, of orthodontic brackets bonded using a new resin-reinforced, chemically cured "moisture-friendly" glass ionomer cement by two recommended methods.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Dental Materials

Intervention

Randomised controlled trial. Random allocation to:
A. Method 1
B. Method 2

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Bracket survival
2. Tooth type, e.g. incisor canine premolar versus debond incidence
3. Adhesive Remnant Index assessment score
4. Chairside cleanup time

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2001

Overall trial end date

01/10/2003

Reason abandoned

Eligibility

Participant inclusion criteria

60 Consecutive healthy subjects aged between 10-18 years from the orthodontic treatment waiting list at St James's Hospital requiring orthodontic treatment with upper and lower fixed appliances will be randomly allocated to the two study groups.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/2001

Recruitment end date

01/10/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oral and Maxillo-facial Surgery
Leeds
LS9 7TF
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

Hospital/treatment centre

Funder name

Leeds Teaching 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

16/03/2016: No publications found, verifying study status with principal investigator.