Comparing two devices with visual examination to assess tooth colour

Not Applicable

• Conditions: Tooth discolouration; Oral Health

• Registration Number: ISRCTN80200202
• Lead Sponsor: niversity of Manchester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-12
• Study Completion: 2019-07-12
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified