Healthy volunteers with varying degrees of gingival recession ranging from no recession to severe recession Oral Health
Conditions
Interventions
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 par
Sponsors
3Shape (Denmark)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
England, United Kingdom
Contacts
Public ContactNicola West
Outcome results
None listed