Plain English Summary
Background and study aims
Dental radiographs (X rays) are usually taken immediately after completion of root canal treatment and on a periodic basis (review appointments), usually after 1 and 2 years after treatment has been completed, to assess how successful treatment has been. The amount of information gained from conventional dental radiographs is limited as the images produced are only 2 dimensional (like a photograph). A 3-dimensional scan called a Cone Beam Computed Tomography (CBCT) scan is the latest technology for imaging teeth. It allows the tooth to be assessed in 3-dimensions and therefore potentially provides more useful information including the degree of healing. This CBCT scan may provide a better understanding of the anatomy of the tooth before carrying out root canal treatment. The aim of this study is to compare 2D radiographs and 3D CBCT scans to find out whether this new 3D scanning technique is more accurate and helpful in assessing healing of root canal treatment.
Who can participate?
Healthy volunteers, over 18 years old
What does the study involve?
Immediately before root canal treatment is started, an additional 3D CBCT scan of the tooth is taken in addition to the conventional 2D radiograph. The additional scan takes 5-10 minutes to carry out. Review appointments are arranged 1 and 2 years after the end of the root canal treatment to assess the healing of the tooth. If the degree of healing is uncertain at this time, an additional review and scan may be required 4 years after the end of the treatment. However, this is not common. In some instances, only a deep filling may be required either on its own (i.e. no root canal treatment), or together with root canal treatment to manage the root canal problem. When indicated, there may be no active treatment apart from periodic review appointments as described. In addition to using the inbuilt CBCT software, additional third party software may also be used to assess the anatomy of the tooth in anticipation of gaining further information about the tooth which may in turn help to treat the tooth more efficiently and effectively.
What are the possible benefits and risks of participating?
CBCT may allow dentists to accurately assess whether treatment has been successful. The additional radiation dose from the second scan is minimal and is very similar to the conventional radiograph. The chance of any harm occurring as a result of exposure to dental X ray radiation is very small. The effective dose of each of these cone beam computed scans is equivalent to 3-4 days of annual background radiation, so for the whole study the extra scans are equivalent to less than 10 days of background radiation. To put this in perspective, the effective dose from cosmic radiation on board an aircraft flying a round trip from Paris to Tokyo is equivalent to 15 days of annual background radiation.
Where is the study run from?
1. Endodontic PG unit, Guy's & St Thomas' NHS Foundation Trust, London, UK
2. Dr Shanon Patel, 45 Wimpole Street, London, UK
When is the study starting and how long is it expected to run for?
September 2015 to August 2018
Who is funding the study?
Kings College London (UK)
Who is the main contact?
Dr Shanon Patel
Prospective clinical trials to determine the impact of various treatments on the outcome of endodontic disease assessed with cone beam computed tomography
Cone beam computed tomography (CBCT) is more sensitive than periapical radiographs in determining outcome of treatment. Radiographic signs of healing will be identified earlier with CBCT. Teeth with signs of complete healing on conventional radiographs may still have radiographic signs of endodontic disease when assessed with CBCT.
London Bridge Research Ethics Committee, 14/09/2015, ref: 08/H0804/79
Prospective multicentre clinical study
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Immediately before root canal treatment is commenced in addition to the conventional radiograph a CBCT scan is carried out. Review appointments will also be arranged 1 and 2 years after the completion of root canal treatment to assess the healing of the tooth. If the degree of healing is uncertain at this time, an additional review and scan may be required 4 years after completion of treatment. In addition to using the inbuilt CBCT software, an additional third party software may also be used to assess the anatomy of the tooth.
Primary outcome measures
Clinical and radiographic signs of healing, assessed using recognised outcome criteria (Patel et al., 2012) at 1 and 2 years post treatment
Secondary outcome measures
Operator stress levels during treatment, measured at the end of treatment
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Adults (over 18) who are able give verbal and written consent
2. Not pregnant
3. Not immunocompromised
Target number of participants
Participant exclusion criteria
1. Children (<18 years old)
2. Pregnant patients
4. Existing advanced gum disease
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Guy's & St Thomas' NHS Foundation Trust
Trial participating centre
45 Wimpole Street
Kings College London
Funding Body Type
private sector organisation
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in high impact dental journals.
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
Participant level data
To be made available at a later date
Results - basic reporting