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 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
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
-
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.