NCT02676219

Pilot Study Utilising an Impression Technique to Capture in Vivo Images of Teeth

Pilot Study to Investigate the Reparative Effect of a Two Phase Oral Care Product Containing SMFP and NaF on Enamel Against a Dietary Acid Exposure Utilising an Impression Technique to Capture in Vivo Images of Teeth

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Unilever R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study design is a randomised, split mouth, blind with respect to study analysts (microscopist, image grader) two treatment clinical study in 10 healthy participants with sound tooth enamel. The study will comprise of a screening visit, pre-baseline visit and 5 subsequent clinic visits. At the screening visit, participants will give consent to participate in the study. Medical history and concomitant medications will be recorded. Eligibility will be determined following an oral soft tissue (OST) examination and an evaluation of dentition exclusions. Two suitable anterior teeth will be identified for study assessments, these teeth must be at least one tooth apart in the mouth. Saliva samples will be collected from the participants at set points during the study to look at any changes in salivary pH.

Conditions

• Tooth Erosion

Interventions

Type	Name	Description
OTHER	RS01	Oral Care product containing sodium monofluorophosphate and sodium fluoride
OTHER	Water

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-09-18
• Completion: 2015-09-18
• First posted: 2016-02-08
• Last updated: 2018-06-08

Locations

1 site across 1 country: United Kingdom