Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0233114350
Study information
Scientific title
Acronym
Study hypothesis
Null hypothesis: there is no difference in bond failure between direct and indirect bonding techniques.
Patient Volunteers, Healthy Volunteers, Children under 16, Multi centre, Single Blind, Grant Funding, Prospective, Observational, Longitudinal, Randomised, No Funding, Controlled, Case Control.
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
Not Specified
Patient information sheet
Condition
Oral Health: Orthodontics
Intervention
The interventions arms are to see whether there is any differnce between direct and indirect bonding of fixed braces on patients' teeth.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The aim of this study is to see if there is any difference between the two placement methods if failure of the brackets to stick to the teeth.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
24/05/2002
Overall trial end date
31/05/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Patients undertaking orthodontic treatment.
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
24/05/2002
Recruitment end date
31/05/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Birmingham Dental Hospital
Birmingham
B4 6NN
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
R&D Consortium of Birmingham Primary Care Trusts (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
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16926313
Publication citations
-
Results
Thiyagarajah S, Spary DJ, Rock WP, A clinical comparison of bracket bond failures in association with direct and indirect bonding., J Orthod, 2006, 33, 3, 198-204, doi: 10.1179/146531205225021615.