Condition category
Oral Health
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
04/08/2008
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 N W T Harradine

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

N0264149441

Study information

Scientific title

Acronym

Study hypothesis

To investigate if a new glue system reduces the number of brackets (orthodontic brace attachments to teeth) which debond (glue fails) during treatment with fixed 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

Not specified

Trial type

Treatment

Patient information sheet

Condition

Oral Health

Intervention

A split mouth design will be used with right and left in the upper arch decided by random allocation with random number tables. Only incisors, canines and premolars will be included in the study.

The two types of primer to be used for bonding are the following:
1. OrthoSolo Bond enhancer
2. Transbond XT conventional adhesive

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Bond failure rate.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2004

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 16 or under
2. Both arches to be treated with fixed appliances
3. Written consent given to be included in the trial

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

33

Participant exclusion criteria

Patients not meeting inclusion criteria.

Recruitment start date

01/07/2004

Recruitment end date

30/06/2008

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 (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (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

Results in http://www.ncbi.nlm.nih.gov/pubmed/18287392

Publication citations

  1. Results

    Wenger NA, Deacon S, Harradine NW, A randomized control clinical trial investigating orthodontic bond failure rates when using Orthosolo universal bond enhancer compared to a conventional bonding primer., J Orthod, 2008, 35, 1, 27-32, doi: 10.1179/146531207225022392.

Additional files

Editorial Notes