ISRCTN80200202Unknown未知
A clinical study to evaluate the performance of visual assessment and novel imaging methods to monitor and assess changes in tooth colour.
niversity of Manchester0 sites50 target enrollmentStarted: April 12, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
- •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
Investigators
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