Gum health Oral Health
Conditions
Interventions
The aim of this study is to investigate the accuracy of 3D intra-oral scanner images (3Shape Trios Scanner) to monitor gingival health compared to traditional assessments made with standard clinical a
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be aged 18 years and over, of either gender and in good health 2. Be willing and physically able to undergo all study procedures 3. Be willing and competent (verbally and cognitively) to give written informed consent 4. Have at least 20 natural teeth
Exclusion criteria
Exclusion criteria: 1. Current participation in any other cosmetic trials, any dental clinical trials or clinical trials 2. Obvious signs of untreated caries or significant periodontal disease, which in the opinion of the Study Dentist, will affect either the scientific validity of the study 3. A periodontal pocket depth ?4 mm in the anterior upper or lower sextants 4. Any participant who, in the judgement of the investigator, should not participate in the study 5. Current orthodontic treatment 6. An immediate employee of the sponsor or the research team conducting the study. Employees of the Sponsor or research site not associated with the research team are eligible to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The accuracy of intra-oral 3D scanner derived assessment of gingival inflammation compared to standard clinically derived direct scoring of clinical inflammation, both using the modified gingival index (MGI). Gingival health will be measured using a 5-point MGI scale recorded clinically by examiner 1. MGI scores recorded by examiner 1 for clinical scoring will be compared with MGI scores recorded by examiner 1 and examiner 2 from the scans for the same 210 gingival sites. The MGI (0, 1, 2, 3 or 4) will be recorded and compared for scorable teeth in the upper and lower anterior sextants at 2 sites, the gingival unit buccally and lingual/palatally), per tooth. Measured at a single visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at a single visit: 1. The sensitivity of the intra-oral 3D scanner derived assessment of gingival inflammation to differentiate between healthy gingivae, mild gingivitis, moderate and severe gingivitis (MGI 0, 1, 2, 3, 4) 2. Inter-examiner variability of scoring clinical gingival health from intra-oral 3D scanner images using MGI scores 3. Colour and textual changes in scanned images compared with clinically derived MGI scores of gingival healthy and diseased sites | — |
Countries
England, United Kingdom
Outcome results
None listed