Contact information
Type
Scientific
Primary contact
Mr DO Morris
ORCID ID
Contact details
Oral and Maxillo-facial Surgery
Chancellor Wing
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 206 3697
david.morris@leedsth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436121385
Study information
Scientific title
A randomised prospective clinical trial to compare two different methods of applying a new resin-reinforced chemically-cured "moisture-friendly" glass ionomer cement for the bonding of orthodontic brackets
Acronym
Study hypothesis
The study will be used to investigate the clinical failure rate, using the survival rate analysis, of orthodontic brackets bonded using a new resin-reinforced, chemically cured "moisture-friendly" glass ionomer cement by two recommended methods.
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
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Dental Materials
Intervention
Randomised controlled trial. Random allocation to:
A. Method 1
B. Method 2
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Bracket survival
2. Tooth type, e.g. incisor canine premolar versus debond incidence
3. Adhesive Remnant Index assessment score
4. Chairside cleanup time
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2001
Overall trial end date
01/10/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
60 Consecutive healthy subjects aged between 10-18 years from the orthodontic treatment waiting list at St James's Hospital requiring orthodontic treatment with upper and lower fixed appliances will be randomly allocated to the two study groups.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
60
Total final enrolment
49
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2001
Recruitment end date
01/10/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oral and Maxillo-facial Surgery
Leeds
LS9 7TF
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
Hospital/treatment centre
Funder name
Leeds Teaching Hospitals NHS Trust (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
Basic results (scientific)
Publication list
2005 results presented at the British Orthodontic Society conference, with an abstract published in the Journal of Orthodontics 2005; 32(2): 140-141 and titled "Clinical evaluation of Fuji-Ortho glass ionomer cement for orthodontic bonding"; however, the abstract is not available without a subscription (added 17/12/2019)
2005 results presented at the European Orthodontic Conference, titled "A clinical trial of Fuji ORTHO glass ionomer for orthodontic bonding"; however, the abstract does not appear to be available online (added 17/12/2019)
2005 results presented at the International Orthodontic Congress, titled "A clinical trial of Fuji ORTHO glass ionomer for orthodontic bonding"; however, the abstract is not available without a subscription (added 17/12/2019)
2006 results presented at the British Orthodontic Society conference, titled "A Prospective, Randomised Clinical Bonding Trial – to the Finish"; however, the abstract is not available without a subscription (added 17/12/2019)