Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
REC00096
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Oral health/stomatognathic diseases: Oral health/stomatognathic diseases
Intervention
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).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
External assessment of degree of healing observed in post-operative radiographs.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/1997
Overall trial end date
01/06/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
320
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/1997
Recruitment end date
01/06/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UMDS
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive London (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2003 results on http://www.ncbi.nlm.nih.gov/pubmed/12887380
Publication citations
-
Results
Chong BS, Pitt Ford TR, Hudson MB, A prospective clinical study of Mineral Trioxide Aggregate and IRM when used as root-end filling materials in endodontic surgery., Int Endod J, 2003, 36, 8, 520-526.