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 |
| IRAS number | 339903 |
| Secondary identifying numbers | IRAS 339903 |
- Submission date
- 12/03/2024
- Registration date
- 22/03/2024
- Last edited
- 21/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
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 October 2024
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
| Study design | Single-centre non-randomized non-interventional cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Dental clinic |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use contact details to request a 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 hypothesis | 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 |
| Condition | 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 |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | TRIOS 5 intraoral 3D scanner system |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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. 2. Diagnostic precision measures to assess variability between (i.e., reproducibility - inter-examiner variability) and within examiners (i.e., repeatability - intra-examiner variability) for the on-scan assessment of gingival recession - the proportion of agreement and Cohen’s kappa will be used for qualitative binary outcome data and the graphical and point estimate representations of the concordance correlation coefficient and the Bland and Altman limits-of-agreement will be used for quantitative continuous outcome data 3. Diagnostic accuracy measures of sensitivity and specificity for comparison of an algorithm on-scan assessment to the clinical and manual on-scan assessment of gingival recession at the site level by using binary outcome data indicating the presence or absence of gingival recession constructed by defining a cut-off, i.e., 1 mm or greater 4. Measurement agreement measures as used in Bland-Altman analysis for comparison of an algorithm on-scan assessment to the clinical and manual on-scan assessment of gingival recession at the site level 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. |
| Overall study start date | 15/01/2024 |
| Overall study end date | 18/10/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 109 |
| Participant 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 |
| Participant 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. |
| Recruitment start date | 06/03/2024 |
| Recruitment end date | 18/06/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bristol
BS1 2lX
United Kingdom
Sponsor information
Industry
Holmens Kanal 7
Copenhagen
1060
Denmark
| Phone | +45 (0)30952141 |
|---|---|
| josefine.jensen@3shape.com | |
| Website | https://www.3shape.com/ |
"ROR" |
https://ror.org/042cmjn68 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 18/10/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study are not expected to be made available due to intellectual property rights and commercial protection of 3Shape A/S. |
Editorial Notes
12/03/2024: Study's existence confirmed by London - Riverside Research Ethics Committee.
