A clinical and laboratory study of the performance of a dual-cured glass-ionomer cement as a bonding agent for orthodontic brackets.

ISRCTN	ISRCTN70334837
DOI	https://doi.org/10.1186/ISRCTN70334837
Secondary identifying numbers	94060005

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Nigel Carter
Scientific

Dental School
Framlington Place
University of Newcastle
Newcastle upon Tyne
NE2 4BW
United Kingdom

Phone	+44 (0)191 222 8347

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title
Study objectives	To assess the clinical performance of a resin-modified glass ionomer cement as an orthodontic bonding agent, and to compare these findings with the results of laboratory tests of bond performance.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Oral health/stomatognathic diseases
Intervention	Each patient will be allocated randomly to one of three test groups : 1. Glass-ionomer without sandblasting vs. composite resin 2. Glass-ionomer with sandblasting vs. composite resin 3. Glass-ionomer with sandblasting vs. glass-ionomer without sandblasting
Intervention type	Other
Primary outcome measure	Clinical bracket failure rates. In vitro: bracket bond strengths and fatigue (assessed using a ball mill); fluoride release over time
Secondary outcome measures	Not provided at time of registration
Overall study start date	04/01/1994
Completion date	04/01/1996

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	Not provided at time of registration
Key inclusion criteria	Patients attending for routine orthodontic treatment using fixed appliances.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	04/01/1994
Date of final enrolment	04/01/1996

Dental School

Newcastle upon Tyne
NE2 4BW
United Kingdom

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

NHS Executive Northern and Yorkshire (UK)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/1995		Yes	No