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

ISRCTN	ISRCTN61972161
DOI	https://doi.org/10.1186/ISRCTN61972161
Secondary identifying numbers	N0436121385

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 17/12/2019

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 DO Morris
Scientific

Oral and Maxillo-facial Surgery
Chancellor Wing
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom

Phone	+44 (0)113 206 3697
Email	david.morris@leedsth.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Dental Materials
Intervention	Randomised controlled trial. Random allocation to: A. Method 1 B. Method 2
Intervention type	Other
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 study start date	01/10/2001
Completion date	01/10/2003

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	10 Years
Upper age limit	18 Years
Sex	Both
Target number of participants	60
Total final enrolment	49
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/2001
Date of final enrolment	01/10/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Oral and Maxillo-facial Surgery

Leeds
LS9 7TF
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Leeds Teaching Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	A clinical trial of Fuji ORTHO glass ionomer for orthodontic bonding	01/06/2005	17/12/2019	No	No
Abstract results	abstract page 140-141	01/06/2005	17/12/2019	No	No

Editorial Notes

17/12/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added.
05/12/2019: No publications found, verifying study status with principal investigator.
16/03/2016: No publications found, verifying study status with principal investigator.