Condition category
Oral Health
Date applied
28/01/2018
Date assigned
07/02/2018
Last edited
05/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Public

Primary contact

Dr Shanon Patel

ORCID ID

Contact details

Endodontic Postgraduate Unit
Floor 25 Guy’s Tower
Guy’s Hospital
London
SE1 9RT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

REC 08/h0804/79

Study information

Scientific title

Prospective clinical trials to determine the impact of various treatments on the outcome of endodontic disease assessed with cone beam computed tomography

Acronym

Study hypothesis

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.

Ethics approval

London Bridge Research Ethics Committee, 14/09/2015, ref: 08/H0804/79

Study design

Prospective multicentre clinical study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Endodontic disease

Intervention

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.

Intervention type

Other

Phase

Drug names

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

14/09/2015

Overall trial end date

31/08/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults (over 18) who are able give verbal and written consent
2. Not pregnant
3. Not immunocompromised

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. Children (<18 years old)
2. Pregnant patients
3. Immunocompromised
4. Existing advanced gum disease

Recruitment start date

01/01/2016

Recruitment end date

31/08/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Guy's & St Thomas' NHS Foundation Trust
London
SE1 9RT
United Kingdom

Trial participating centre

Shanon Patel
45 Wimpole Street
London
W1G 8SB
United Kingdom

Sponsor information

Organisation

NHS Health Research Authority, London Bridge Research Ethics Committee

Sponsor details

Skipton House
80 London Road
London
SE1 6LH
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

University/education

Funder name

Kings College London

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

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

01/09/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes