Tooth wear detection aid
| ISRCTN | ISRCTN16797270 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16797270 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 334050 |
| Protocol serial number | IRAS 334050 |
| Sponsor | 3Shape (Denmark) |
| Funder | 3Shape A/S |
- Submission date
- 04/06/2024
- Registration date
- 14/06/2024
- Last edited
- 12/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Tooth wear is a non-reversible loss of dental tissue and the prevalence has increased. Early diagnosis and prevention are important, however, clinical assessment of tooth wear sustains challenges. These challenges involve relying on a qualitative assessment of tooth wear, including heavily relying on visual assessment and difficulty in comparing tooth wear in a patient over time. Being able to assess tooth wear on scans directly, rather than only in the patient's mouth, may assist the dentist in making a reliable assessment of tooth wear. On a 3D scan, the dentist can have a better view of the teeth, zoom in, save measurements for later on, and show the patient the problem.
Who can participate?
Any adult with tooth wear ranging from none to severe on any tooth can participate.
What does the study involve?
The participant will get a 3D scan of their teeth and the clinician will perform the standard clinical examination for tooth wear (Basic Erosive Wear Examination).
What are the possible benefits and risks of participating?
The possible benefit of participating is that participants may discover conditions of their teeth they were otherwise unaware of – this can be related to the trial’s subject (tooth wear) or unrelated (for example, caries that need treatment). The risks of participating are that some participants may feel minimal discomfort from having their teeth scanned.
Where is the study run from?
3Shape (Denmark)
When is the study starting and how long is it expected to run for?
January 2024 to March 2025
Who is funding the study?
3Shape (Denmark)
Who is the main contact?
Dr Saoirse O'Toole, saoirse.otoole@kcl.ac.uk
Contact information
Public, Scientific, Principal investigator
16th Floor, Tower Wing
Guys Hospital
London
SE1 9RT
United Kingdom
 ORCID ID |
0000-0002-2144-1847 |
|---|---|
| Phone | +44 7913314234 |
| saoirse.otoole@kcl.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Non-randomized and non-interventional single-center cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Investigating the utility of 3D intraoral scan imaging to score tooth wear compared to visual clinical assessment |
| Study objectives | To assess the diagnostic accuracy of intraoral 3D scanner-derived detection by dichotomous outcome (yes/no) of tooth wear compared to the standard clinical visually-derived direct scoring of tooth wear. |
| Ethics approval(s) |
Approved 08/04/2024, Leicester South REC (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8079; leicestersouth.rec@hra.nhs.uk), ref: 24/EM/0064 |
| Health condition(s) or problem(s) studied | Tooth wear in a variety of severity from none to severe |
| Intervention | The patient will be screened according to the inclusion and exclusion criteria - they may have varying degrees of tooth wear. The clinician will then perform the 3D intraoral scan (using CE-marked equipment within its intended purpose), and the clinician will then perform the standard clinical examination for tooth wear (the Basic Erosive Wear Examination). This is a visual examination. Without involving the patient, the clinician will also perform the tooth wear examination directly on the scan. Two weeks later, the clinician will score the tooth wear directly on the scan once more. Another clinician, blinded to the clinical truth, will also perform the tooth wear assessment on the scan. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Trios 5 intraoral scanner |
| Primary outcome measure(s) |
Tooth wear measured using intraoral 3D scanner and standard clinical visually-derived direct scoring at baseline and 2 weeks |
| Key secondary outcome measure(s) |
1. To assess diagnostic accuracy of an algorithm on tooth wear detection on patient-level by dichotomous outcome (tooth wear: yes/no) compared to the clinical reference standard scoring of tooth wear (BEWE sum score cut-off 0-2 vs. 3-18) |
| Completion date | 03/03/2025 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 62 |
| Key inclusion criteria | 1. Participant is willing and able to give informed consent for participation in the study 2. Male or Female, adults aged 18 years or above 3. A minimum of 20 natural teeth present (10 teeth in each jaw) 4. Able (in the Investigators opinion) and willing to comply with all study requirements |
| Key exclusion criteria | 1. Patients with extensive restorative or prosthodontic treatment (greater than 4 crowned teeth) 2. Extensive active dental decay 3. Periodontally mobile teeth 4. Trismus (i.e., inability to open the mouth wide) 5. Presence of orthodontic brackets or clear aligner attachments |
| Date of first enrolment | 07/06/2024 |
| Date of final enrolment | 11/11/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
London
SE1 9RT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/11/2024: The following changes were made to the trial record:
1. The secondary outcome measures were added.
2. The recruitment end date was changed from 03/01/2025 to 11/11/2024.
04/06/2024: Trial's existence confirmed by NHS HRA.
