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ISRCTN
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ISRCTN58467151
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ClinicalTrials.gov identifier
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Public title
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The effectiveness of an internet based computer database for data collection in a randomised controlled trial to evaluate immediate extirpation of necrotic pulp tissue and placement of Ledermix® in avulsed and replanted teeth in comparison to the current recommendations
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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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Version 2, 9-12-04
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Study hypothesis
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This is a multi-centre randomised controlled trial to compare the effectiveness of Ledermix® and Ultracal XS® on the type of healing (favourable or unfavourable) following tooth avulsion and replantation.
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Lay summary
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Not provided at time of registration
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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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Tooth avulsion and replantation
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Participants - inclusion criteria
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There are two ways to be accepted onto the trial; acute and delayed presentation to the specialist unit.
Inclusion criteria for acute presentation are:
1. Patients who have avulsed a tooth that has been replanted and are under the age of 16 years
2. The tooth has completed root development with or without an open apex (as these teeth have no chance of pulpal regeneration)
3. With no more than 20 minutes dry extra-alveolar time
4. A maximum total time of one hour has elapsed with the tooth being kept outside the mouth in milk or other storage media and a maximum of 20 minutes being kept in dry conditions
5. With no previous endodontic treatment carried out
6. The patient presents to the specialist unit within ten days following the injury (this ensures that the patient has a chance of randomly being entered into one or other treatment group)
Inclusion criteria for delayed presentation:
1. Where replantation has been carried out away from a specialist centre and is performed within the guidelines of the International Association of Dental Traumatology (2003)
2. Details can be obtained from the dentist who provided this treatment (e.g. extra alveolar time, extra alveolar medium, dry time, surface contamination, antibiotics, etc.)
3. Meets the same inclusion criteria as listed above for acute presentation
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Participants - exclusion criteria
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Not fulfilling the inclusion criteria
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Anticipated start date
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20/07/2005
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Anticipated end date
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30/09/2008
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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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200
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Interventions
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Pulp extirpation as early as possible (Day 0–10) following tooth avulsion and placement of Ledermix® versus pulp extirpation at Day 7–10 and placement of Ultracal XS® (non setting calcium hydroxide).
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Primary outcome measure(s)
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To compare the effect of these two root canal pastes on the periodontal healing and consequent tooth survival.
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Secondary outcome measure(s)
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To evaluate the effectiveness of a web based computer database for data collection in a multi-centred randomised controlled trial for two types of treatment for avulsion injuries.
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Sources of funding
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Blackwell Supplies (purchase of equipment and free materials)
Optident (free materials)
Medartis (free materials)
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Trial website
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Publications
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1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21763893
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Contact name
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Dr
Peter
Day
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Address
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Department of Paediatric Dentistry
Level 6
Leeds Dental Institute
Clarendon Way
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City/town
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Leeds
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Zip/Postcode
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LS2 9LU
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Country
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United Kingdom
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Tel
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+44 (0)113 343 6138/9
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Fax
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+44 (0)113 3436140
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Email
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p.f.day@leeds.ac.uk
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Sponsor
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University of Leeds (UK)
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Address
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Senior Research Manager
School of Medicine
24 Hyde Terrace
University of Leeds
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City/town
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Leeds
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Zip/Postcode
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LS2 9LN
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Country
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United Kingdom
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Tel
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+44 (0)113 343 3264
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Fax
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+44 (0)113 343 4217
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Email
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j.gower@leeds.ac.uk
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Date applied
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30/08/2005
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Last edited
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21/12/2011
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Date ISRCTN assigned
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12/10/2005
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