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ISRCTN
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ISRCTN22673915
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ClinicalTrials.gov identifier
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Public title
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Improving the success rate of apicectomies by using Mineral Trioxide Aggregate
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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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REC00096
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Study hypothesis
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The aim of the project is to improve the success rate of apicectomy with root-end filing, a procedure used to manage teeth for which root canal treatment has failed, resulting in continued alveolar infection. This is a widespread form of treatment. The success rate reported in a number of studies is little better than chance. Intensive research in the last 5 years has indicated the mechanisms of failure of this treatment, and potential ways to avoid it. Too often infection remains inside the tooth. Treatment techniques have been modified to clean the tooth better and to reduce communication between the inside of the tooth and the body tissues. There is a need to investigate the success rate of the modified procedure in patients to see if it fulfils the initial results of the laboratory research.
It is planned to recruit patients who require apicectomy according to specific criteria of indication. A total of 320 patients will be randomly allocated to two groups; the control group will have root-end resection with minimal bevelling followed by ultrasonic cavity preparation, and then filling with what is now the current material, IRM; the experimental group will have similar treatment except that the filling material will be the newly developed Mineral Trioxide Aggregate (MTA). The MTA has very good sealing properties and biocompatibility. The teeth will be reviewed at 1 and 2 years post-operatively for clinical and radiological signs of healing or failure, according to specific criteria. The proportions of teeth successful in the two groups will be compared using statistical methods.
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Lay summary
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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: Oral health/stomatognathic diseases
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Participants - inclusion criteria
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Adult patients who are referred to Guy's Hospital for apicectomy will be invited to participate. The entry criteria will be that the tooth has apical periodontitis, the tooth could not be adequately and better managed by root canal retreatment, the tooth has an adequate root canal filling, the crown of the tooth is adequately restored, and periodontal probing depths <4 mm except for a unilocular sinus tract.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/06/1997
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Anticipated end date
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01/06/2002
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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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320
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Interventions
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1. (Experimental group) root-end resection with minimal bevelling followed by ultrasonic cavity preparation, and the filling material will be the newly developed Mineral Trioxide Aggregate (MTA).
2. (Control group) root-end resection with minimal bevelling followed by ultrasonic cavity preparation, and then filling with what is now the current material, intermediate restorative material (IRM).
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Primary outcome measure(s)
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External assessment of degree of healing observed in post-operative radiographs.
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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 London (UK)
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Trial website
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Publications
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2003 results on http://www.ncbi.nlm.nih.gov/pubmed/12887380
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Contact name
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Prof
Thomas
Pitt-Ford
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Address
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UMDS
Dept of Conservative Dental Surgery
Guy's Hospital
London Bridge
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City/town
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London
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Zip/Postcode
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SE1 9RT
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Country
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United Kingdom
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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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03/12/2008
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Date ISRCTN assigned
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23/01/2004
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