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ISRCTN
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ISRCTN24433142
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ClinicalTrials.gov identifier
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Public title
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Palatal implants versus headgear for orthodontic anchorage - a randomised controlled trial
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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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N0059108300
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Study hypothesis
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To evaluate the clinical effectiveness of the mid-sagittal implant as a method of preventing unwanted tooth movement (anchorage) during orthodontic treatment. The anchorage offered by implants will be compared with that from conventional orthodontic anchorage reinforcement techniques.
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Ethics approval
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Added July 2008: Ethical approval for this study was obtained from North Derbyshire
Health and South Sheffield Local Research Ethics committees.
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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: Orthodontics
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Participants - inclusion criteria
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Added July 2008:
The patients in the study all needed absolute anchorage, and no forward movement of upper molars could be allowed for successful treatment.
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Participants - exclusion criteria
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Added July 2008:
Poor oral hygiene, unwilling to wear fixed appliances, unwilling to wear headgear or have the implant placed, and medical history precluding fixed appliance treatment.
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Anticipated start date
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01/01/2002
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Anticipated end date
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01/06/2005
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet.
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Target number of participants
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40 patients
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Interventions
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The anchorage offered by implants will be compared with that from conventional orthodontic anchorage reinforcement techniques.
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Primary outcome measure(s)
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Tooth movement. The difference in the mesial drift of the buccal teeth to be calculated:
a. Relative to the cranial base using the Pitchfork analysis (Luecke and Johnston, 1992; Johnston, 1996) on the start and finish lateral cephalometric radiograph
b. Relative to the palatal rugae, from the start and finish study models (Hoggan and Sadowsky, 2001)
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Secondary outcome measure(s)
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1. Implant stability, discomfort and any signs of inflammation of the peri-implant tissues will be recorded with percussion tests using a Resonance Frequency Analyser (Meredith, 1998) and standard periodontal indices
2. Patient acceptability, compliance and discomfort measured using a questionnaire
3. Treatment outcome measured with the Peer Assessment Rating (PAR) index on the pre- and post-treatment study models
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Sources of funding
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Sheffield Teaching Hospitals (Central Campus) - UK
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Trial website
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Publications
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1. 2007 results on main outcome in http://www.ncbi.nlm.nih.gov/pubmed/18005834
2. 2008 results on other outcomes in http://www.ncbi.nlm.nih.gov/pubmed/18174071
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Contact name
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Dr
Philip
Benson
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Address
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University of Sheffield
Child Dental Health
Charles Clifford Dental Hospital
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City/town
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Sheffield
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Zip/Postcode
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S10 2SZ
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Country
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United Kingdom
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Tel
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+44 (0)114 271 7895 / 7885
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Fax
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+44 (0)114 271 1901
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Email
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p.benson@sheffield.ac.uk
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Sponsor
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Record provided by the NHS Trusts Clinical Trials 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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12/09/2003
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Last edited
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02/07/2008
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Date ISRCTN assigned
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12/09/2003
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