Improving the success rate of apicectomies by using Mineral Trioxide Aggregate
| ISRCTN | ISRCTN22673915 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22673915 |
| Protocol serial number | REC00096 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive London (UK) |
- 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
Scientific
UMDS
Dept of Conservative Dental Surgery
Guy's Hospital
London Bridge
London
SE1 9RT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
External assessment of degree of healing observed in post-operative radiographs. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
UMDS
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
