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Comparing two devices with visual examination to assess tooth colour

A clinical study to evaluate the performance of visual assessment and novel imaging methods to monitor and assess changes in tooth colour.

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN80200202
Enrollment
50
Registered
2019-04-12
Start date
2019-04-15
Completion date
Unknown
Last updated
2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth discolouration Oral Health

Interventions

Advertisements, in the form of posters, will be placed at the dental practice before the start of the study. If patients would like to participate in the study they can speak to a member of the resear
this examination involves the use of an overhead operating light and a dental mirror. The examiner will also ask about their general medical history. Participants who are successfully

Sponsors

University of Manchester
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Contacts

Public ContactNicola Boothman
nicola.boothman@manchester.ac.uk+44 (0)161 226 1211

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026