Condition category
Oral Health
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
03/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thomas Pitt-Ford

ORCID ID

Contact details

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

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2003 results on http://www.ncbi.nlm.nih.gov/pubmed/12887380

Publication citations

  1. 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.

Additional files

Editorial Notes