Tooth discolouration Oral Health
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years inclusive 2. In good general health, as determined by site investigator 3. Willing to give informed consent, medical history and to comply with the full study protocol 4. Present at screening with a tooth shade score =15 as measured by the Vita Extended BleachedGuide 3D Master on at least one anterior tooth 5. All maxillary and mandibular anterior teeth present without crowns or large restorations
Exclusion criteria
Exclusion criteria: 1. Unable to attend all 5 visits 2. Experiencing acute dental pain and/or infection 3. Soft tissue abnormalities 4. Advanced periodontal disease (purulent exudate, tooth mobility and/or extensive alveolar bone loss) 5. Five or more carious lesions requiring immediate restorative treatment 6. Fixed orthodontic bands 7. Cavitated carious lesions on the anterior teeth requiring immediate restorative treatment 8. Pregnant women or women who are actively breastfeeding 9. Employees of the University of Manchester, Windsor Dental Practice or manufacturing company of the employed study equipment (VITA Zahnfabrik or 3Shape A/S) 10. Known or suspected intolerance or hypersensitivity to any study materials or any of their stated ingredients 11. Have participated in any other oral care study or panel test within the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tooth shade according to the Vita Extended Bleached Guide assessed by visual comparison with the tooth shade guide, digital spectrophotometer (VITA EasyShade) and scanner (TRIOS 3 Scanner) at baseline, day 7, day 10, day 14 and day 21. Inter-method agreement will be assessed via weighted kappa calculations of absolute values and deltas in tooth shade over the study visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Whiteness on the WIO whiteness index assessed by visual comparison with the tooth shade guide, digital spectrophotometer (VITA EasyShade) and scanner (TRIOS 3 Scanner) at baseline, day 7, day 10, day 14 and day 21. | — |
Countries
United Kingdom