Investigating how assessing gingival recession on 3D scans of teeth compares to dentists’ standard clinical assessment
| ISRCTN | ISRCTN62574906 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62574906 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 339903 |
| Protocol serial number | IRAS 339903 |
| Sponsor | 3Shape (Denmark) |
| Funder | 3Shape |
- Submission date
- 12/03/2024
- Registration date
- 22/03/2024
- Last edited
- 12/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Gingival recession happens when the gingiva (gum) starts to shift, either close to the tooth or between the teeth. This can cause sensitivity and lesions where the tooth root is exposed. When you go to the dentist, the clinician assesses if you have recession or not and may monitor the progression of the recession. This is usually done by the dentist identifying landmarks of the teeth and gum that are typically visible in recession. However, these landmarks are not always visible, and the current detection procedure can be inaccurate and difficult to manage. The study will compare a visual assessment of your recession (if you have any), with the recession recorded from your scan. Having an algorithm that can aid in detecting gingival recession on scans would be useful for both clinicians and patients, as you might save time and effort from the current recession detection methods that are used in general dentist practice today. This project is about collecting data that will be used later to check if an algorithm detects gingival recession from intraoral scans comparably to an in-clinic assessment of recession. This research is to aid the Danish company, 3Shape, in developing an algorithm for gingival recession detection aid, which may assist dentists in the future and therefore improve gingival recession management.
Who can participate?
Healthy volunteers aged 18 years or above
What does the study involve?
The study involves getting a 3D scan taken by a dental professional and having the gingiva assessed by standard dental care for assessing gingival recession.
What are the possible benefits and risks of participating?
The possible benefits of participating is discovering the volunteer may have oral conditions they were unaware of. The risks relate to general discomfort many people feel when going to the dentist, such as minor discomfort from having devices in their mouth. The risks are minimal as all devices being used are marketed, and all procedures are standard care procedures.
Where is the study run from?
The Dental Clinical Trials Unit at Bristol Dental Hospital under the University of Bristol (UK)
When is the study starting and how long is it expected to run for?
January 2024 to January 2025
Who is funding the study?
3Shape TRIOS A/S (Denmark)
Who is the main contact?
Prof. Nicola West, N.X.West@bristol.ac.uk
Contact information
Public, Scientific, Principal investigator
Lower Maudlin Street
Bristol
BS1 2LY
United Kingdom
| Phone | +44 (0)117 342 9638 |
|---|---|
| N.X.West@bristol.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre non-randomized non-interventional cross-sectional study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Investigating the utility of 3D intra-oral scan imaging to detect gingival recession compared to clinical assessment |
| Study acronym | CIS002 |
| Study objectives | Gingival recession happens when the gingiva starts to shift, either close to the tooth or between the teeth. This can cause sensitivity and lesions where the tooth root is exposed. When you go to the dentist, the clinician assesses if you have recession or not and may monitor the progression of the recession. This is usually done by the dentist identifying landmarks of the teeth and gingiva that is typically visible in recession. However, these landmarks are not always visible, and the current detection procedure can be inaccurate and difficult to manage. Having an algorithm that can aid in detecting gingival recession on scans would be useful for both clinicians and patients, as you might save time and effort from the current recession detection methods that are used in general dentist practice today. This project is about collecting data that will be used later to check if an algorithm detects gingival recession from intraoral scans comparably to an in-clinic assessment of recession. In this study, teeth and mouth are examined in order to assess the level of recession, if any. This research is also to aid the Danish company, 3Shape, in developing an algorithm for gingival recession detection aid, which may assist dentists in the future and therefore improve gingival recession management. |
| Ethics approval(s) |
Approved 13/02/2024, London - Riverside Research Ethics Committee (2 Redman Place, Stratford, E20 1JQ, United Kingdom; +44 (0)207 104 8171; riverside.rec@hra.nhs.uk), ref: 24/PR/0088 |
| Health condition(s) or problem(s) studied | Healthy volunteers with varying degrees of gingival recession ranging from no recession to severe recession |
| Intervention | This study is a single-arm, cross-sectional, open single-site study that uses CE-marked medical devices within its intended purpose and involves standard dentist procedures. After enrolment, the participant's mouth (teeth, gingiva, palate, tongue) will be examined. Then, the participant will be scanned with an intraoral 3D scanner (3Shape TRIOS A/S, Copenhagen, Denmark). An examiner (dentist or dental research nurse) will clinically assess gingival recession using a periodontal probe as per standard procedure. This is the end of participant involvement. Another examiner (dentist or dental research nurse) who is blinded to the clinical assessment will assess gingival recession directly on the scan. After a wash-out period of 2 weeks, the first examiner who did the clinical assessment will assess gingival recession directly on the scan. After a second wash-out period of 1-2 weeks, the examiner will again assess gingival recession on the scan. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | TRIOS 5 intraoral 3D scanner system |
| Primary outcome measure(s) |
Diagnostic accuracy measures of sensitivity and specificity for comparison of the manual on-scan assessment to the clinical assessment of gingival recession using a periodontal probe. The minimally acceptable performance goal is 75% for both sensitivity and specificity. Measured at one timepoint for the patient; the on-scan assessments are performed by the dentists twice at later timepoints (after a wash-out period of 2 weeks and after a second wash-out period of 1-2 weeks) but this does not include the patient. |
| Key secondary outcome measure(s) |
1. Measurement agreement measures as used in Bland-Altman analysis, i.e., mean difference and 95% limits of agreement, for comparison between the on-scan assessment and the clinical assessment of gingival recession at the site level – a predefined accepted limit of agreement is 2 mm. |
| Completion date | 23/01/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 109 |
| Key inclusion criteria | 1. Willing and able to give informed consent for participation in the study 2. Male or female, aged 18 years or above 3. Good general health (i.e., absence of any condition that the Principal Investigator evaluates as a risk either to the subject or to the data quality) 4. Able (in the Investigators opinion) and willing to comply with all study requirements 5. Minimum of 20 natural teeth from upper right 7 to upper left 7 and lower right 7 to lower left 7 |
| Key exclusion criteria | Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study. |
| Date of first enrolment | 18/03/2024 |
| Date of final enrolment | 11/07/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Bristol
BS1 2lX
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
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
12/11/2025: The following changes were made to the trial record:
1. The date of first enrolment was changed from 06/03/2024 to 18/03/2024
2. The date of final enrolment was changed from 18/06/2024 to 11/07/2024
3. The completion date was changed from 18/10/2024 to 23/01/2025
12/03/2024: Study's existence confirmed by London - Riverside Research Ethics Committee.
