Comparison of Two Dental Techniques Used to Treat Teeth Which Have Become Infected or Painful Following Trauma
NCT ID: NCT01817413
Last Updated: 2015-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2011-02-28
2015-08-31
Brief Summary
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To enable root canal treatment to be carried out, a 'barrier' must be placed at the end of the 'open' root. This can be done using materials called Calcium Hydroxide or Mineral Trioxide Aggregate (MTA). These materials are placed inside the root and sealed into the tooth. However, although they help to provide a barrier, they do not help to strengthen the walls of the root. Treatment with these materials requires multiple visits to the dentist, over a period of up to 18 months.
There is evidence to suggest that an alternative treatment involving 'revascularisation' (recovery of the blood supply to the tooth) and the use of a triple antibiotic paste allows 'natural' root growth to restart, and also strengthens the walls of the root. Treatment can often be carried out in just two visits.
The aim of this study is to discover whether there is a difference between one of two methods of treating non-vital teeth with open ends. It is thought that there will be no significant differences seen between the results of the two techniques.
Children with teeth that fall into this category and require root canal treatment will be given one of two treatments, both of which aim to treat infection, close the root end and to allow healing to take place.
Teeth will receive one of the following methods of root treatment:
1. Revascularisation (recovery of the natural blood supply to the tooth) following placement of an antibiotic paste into the tooth root. The aim of this treatment is to allow 'natural' root growth to restart. Root growth will allow the tooth to form at barrier at the end of the root. No root canal filling will then be necessary.
2. Closure of the open root end by placement of an artificial barrier at the end of the root so that a root canal filling can then be placed. This will be done with a dental material called Mineral Trioxide Aggregate (MTA). Non-vital teeth with an open end are routinely treated in this way at Liverpool Dental Hospital.
Detailed Description
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In both techniques, in order to learn about the bacteria involved in non-vital teeth, the investigators will take samples of the bacteria within the root canal.
The outcomes of the study will provide us with further information about root growth, the bacteria involved in infection of non-vital teeth and the success of the different treatment methods that are available. This information will enable us to increase our understanding of the treatment of non-vital teeth with an open end and help us to explain our treatments to future patients.
All children presenting to Liverpool University Dental Hospital aged between 7 and 25 years of age and who are medically well and cooperative to receive prolonged treatment in the dental chair are eligible to take part in the study if they have a damaged upper front adult tooth in which the nerve has died and the root is open ended. Unfortunately, if there is dental decay in the tooth or a fracture of the root then these teeth are not suitable for this study. In some cases following damage to a tooth, the root of the tooth starts to dissolve and unfortunately these teeth are also not suitable for this study.
Suitable patients attend with their parent or carer for a consultation to the Paediatric Dentistry Clinic at Liverpool University Dental Hospital. Following this visit, if a suitable patient wishes to join our study the investigators will arrange two further visits during which the dental treatment will take place. Following completion of treatment, patients will be asked to return for four check ups over the next year so that the investigators can check that they are happy and that treatment has been successful.
There are no risks or disadvantages to taking part in this study. However, if the tooth does not respond to treatment, or if symptoms of infection arise, then alternative treatment methods may be initiated as necessary.
The study is being funded by the Royal Liverpool and Broadgreen University Hospitals NHS Trust and by the University of Liverpool.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Apexification with MTA
The control group will receive:
Visit 1: root canal dressing with calcium hydroxide Visit 2: apexification with mineral trioxide aggregate (MTA), followed by obturation of the root canal with gutta percha.
Treatment will be carried out over two visits, two weeks apart.
Mineral trioxide aggregate
An apical barrier of mineral trioxide aggregate (MTA cement) will be placed in the tooth root at the open apex in order to achieve root end closure via an apexification technique
Pulp revascularisation
The experimental group will receive:
Visit 1: root canal dressing with triple antibiotic paste Visit 2: pulp revascularisation procedure Treatment will be carried out over two visits, two weeks apart.
Revascularisation
Pulp revascularisation will be induced by instrumentation through the open apex so that a blood clot forms within the root canal in order to achieve root end closure via apexogenesis
Interventions
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Mineral trioxide aggregate
An apical barrier of mineral trioxide aggregate (MTA cement) will be placed in the tooth root at the open apex in order to achieve root end closure via an apexification technique
Revascularisation
Pulp revascularisation will be induced by instrumentation through the open apex so that a blood clot forms within the root canal in order to achieve root end closure via apexogenesis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have no significant medical history
* Cooperative in the dental chair
* Able to commit to the recall schedules prescribed by the study
* Have one or more traumatised non-vital permanent maxillary central incisors with incomplete root development
Exclusion Criteria
* Have a medical history for which the study procedures may place the patient at increased risk
* Have a diagnosis of avulsion or severe intrusion following dental trauma
* Less than half formed
* Have anatomical complexity (such as dens invaginatus)
* Have horizontal or vertical root fractures present
* Have evidence of root resorption
7 Years
25 Years
ALL
No
Sponsors
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Liverpool University Hospitals NHS Foundation Trust
OTHER_GOV
University of Liverpool
OTHER
Responsible Party
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Laura Gartshore
Clinical Lecturer & Postgraduate Research Student
Principal Investigators
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C C Youngson
Role: STUDY_CHAIR
University of Liverpool
Locations
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University of Liverpool
Liverpool, , United Kingdom
Countries
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Related Links
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Current Controlled Trials Registration
Other Identifiers
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Controlled Trials
Identifier Type: REGISTRY
Identifier Source: secondary_id
RD&I 3968, UoL000590
Identifier Type: -
Identifier Source: org_study_id