Improving the success rate of apicectomies by using Mineral Trioxide Aggregate

ISRCTN	ISRCTN22673915
DOI	https://doi.org/10.1186/ISRCTN22673915
Secondary identifying numbers	REC00096

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 03/12/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Thomas Pitt-Ford
Scientific

UMDS
Dept of Conservative Dental Surgery
Guy's Hospital
London Bridge
London
SE1 9RT
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	External assessment of degree of healing observed in post-operative radiographs.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/06/1997
Completion date	01/06/2002

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	320
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/06/1997
Date of final enrolment	01/06/2002

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

UMDS

London
SE1 9RT
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive London (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2003		Yes	No