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ISRCTN
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ISRCTN70334837
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ClinicalTrials.gov identifier
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Public title
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A clinical and laboratory study of the performance of a dual-cured glass-ionomer cement as a bonding agent for orthodontic brackets.
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Scientific title
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Acronym
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N/A
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Serial number at source
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94060005
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Oral health/stomatognathic diseases
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Participants - inclusion criteria
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Patients attending for routine orthodontic treatment using fixed appliances.
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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04/01/1994
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Anticipated end date
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04/01/1996
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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
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Primary outcome measure(s)
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Clinical bracket failure rates. In vitro: bracket bond strengths and fatigue (assessed using a ball mill); fluoride release over time
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NHS Executive Northern and Yorkshire (UK)
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Trial website
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Publications
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1995 results http://www.ncbi.nlm.nih.gov/pubmed/7640255
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Contact name
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Mr
Nigel
Carter
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Address
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Dental School
Framlington Place
University of Newcastle
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City/town
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Newcastle upon Tyne
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Zip/Postcode
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NE2 4BW
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Country
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United Kingdom
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Tel
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+44 (0)191 222 8347
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Email
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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18/01/2010
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Date ISRCTN assigned
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23/01/2004
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