Plaque and gingivitis Oral Health
Conditions
Interventions
The study utilises a randomised, parallel, two-group design.
Advertisements, in the form of posters, will be placed at the dental practice one month before the start of the study. If
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 18 to 65 years inclusive 2. Available for the 6-week study duration 3. Have a smartphone and are familiar with using smartphone applications 4. Access to Wi-Fi where they are performing oral hygiene 5. Minimum of 20 natural teeth, including 1 molar in each quadrant, with no extensive restorations present i.e. no crowns, no fillings covering multiple surfaces (excluding 3rd molars) 6. Initial gingival assessment with at least 4 bleeding sites 7. Able to read, understand and agree to the informed consent procedure 8. Able to tolerate an oral examination by a dental professional 9. Good general health
Exclusion criteria
Exclusion criteria: 1. Fixed orthodontic appliances, including orthodontic bands that interfere with any clinical assessment (plaque scoring) 2. Presence of partial removable dentures 3. Five or more decayed, untreated dental sites (cavities) 4. Advanced periodontal disease, with oral lesions or periodontal pockets >5.5 mm (gum disease) 5. Medical condition which requires pre-medication prior to dental visits/procedures 6. Use of drugs that can affect salivary flow 7. Use of antibiotics 1 month prior to or during this study 8. Allergy to common dentifrice ingredients 9. Pregnant or breastfeeding 10. Unable to attend all 3 visits 11. Have a cognitive impairment that prevents participation in the informed consent procedure 12. Have participated in any other oral care study or consumer/panel test within the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Plaque levels assessed using Rustogi Modified Plaque Index at baseline and 6 weeks 2. Gingivitis level assessed visually using Modified Gingival Index (MGI) at baseline and 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Brushing duration assessed using the app at baseline visit, 3 weeks and 6 weeks 2. Surface coverage assessed using the app at baseline visit, 3 weeks and 6 weeks 3. Brushing frequency assessed using the app at 3 weeks and 6 weeks 4. Perceived value at the individual level through collection of patient-reported experience measures (PREMS) using a previously validated 15-point oral health and brushing questionnaire at baseline, 3 weeks and 6 weeks 5. Diagnostic utility of the 3D intraoral scans for the measurement of plaque and gingivitis levels intraorally assessed using a TRIOS intraoral scanner at baseline and 6 weeks | — |
Countries
United Kingdom
Outcome results
None listed