Condition category
Oral Health
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
18/01/2010
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 Nigel Carter

ORCID ID

Contact details

Dental School
Framlington Place
University of Newcastle
Newcastle upon Tyne
NE2 4BW
United Kingdom
+44 (0)191 222 8347

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

94060005

Study information

Scientific title

Acronym

Study hypothesis

To assess the clinical performance of a resin-modified glass ionomer cement as an orthodontic bonding agent, and to compare these findings with the results of laboratory tests of bond performance.

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

Treatment

Patient information sheet

Condition

Oral health/stomatognathic diseases

Intervention

Each patient will be allocated randomly to one of three test groups :
1. Glass-ionomer without sandblasting vs. composite resin
2. Glass-ionomer with sandblasting vs. composite resin
3. Glass-ionomer with sandblasting vs. glass-ionomer without sandblasting

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Clinical bracket failure rates. In vitro: bracket bond strengths and fatigue (assessed using a ball mill); fluoride release over time

Secondary outcome measures

Not provided at time of registration

Overall trial start date

04/01/1994

Overall trial end date

04/01/1996

Reason abandoned

Eligibility

Participant inclusion criteria

Patients attending for routine orthodontic treatment using fixed appliances.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

04/01/1994

Recruitment end date

04/01/1996

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dental School
Newcastle upon Tyne
NE2 4BW
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
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.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (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

1995 results http://www.ncbi.nlm.nih.gov/pubmed/7640255

Publication citations

  1. Results

    Millett DT, McCabe JF, Bennett TG, Carter NE, Gordon PH, The effect of sandblasting on the retention of first molar orthodontic bands cemented with glass ionomer cement., Br J Orthod, 1995, 22, 2, 161-169.

Additional files

Editorial Notes