A randomised controlled trial investigating the orthodontic bracket bond failure rates using Ortho Solo Universal bond enhancer compared to a conventional bonding primer

ISRCTN ISRCTN35457694
DOI https://doi.org/10.1186/ISRCTN35457694
Secondary identifying numbers N0264149441
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
04/08/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr N W T Harradine
Scientific

C/O Research & Effectiveness Department
Level 1, The Old Building
Bristol Royal Infirmary
Malborough Street
Bristol
BS2 8HW
United Kingdom

Phone +44 (0)117 928 3473
Email r&eoffice@ubht.swest.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedOral Health
InterventionA 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 typeOther
Primary outcome measureBond failure rate.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/07/2004
Completion date30/06/2008

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit16 Years
SexNot Specified
Target number of participants33
Key inclusion criteria1. Aged 16 or under
2. Both arches to be treated with fixed appliances
3. Written consent given to be included in the trial
Key exclusion criteriaPatients not meeting inclusion criteria.
Date of first enrolment01/07/2004
Date of final enrolment30/06/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

United Bristol Healthcare NHS Trust (UK)

No information available

NHS R&D Support Funding (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/03/2008 Yes No