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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tooth Erosion
- Sponsor
- Unilever R&D
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- changes in enamel surface topography using an impression methodology with scanning electron microscopy
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- •Age: Aged at least 18 years.
- •Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
- •General Health: Good general health with (in the opinion of the investigator or medically qualified designee) no clinically significant and relevant abnormalities of medical history or physical examination.
- •Study teeth must show no signs of exposed dentine at the cervical margin.
- •In the opinion of the investigator the study teeth must have a healthy gingiva as determined during the OST examination.
Exclusion Criteria
- •Pregnancy Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- •Breast-feeding Women who are breast-feeding.
- •Current or recurrent disease/dental pathology that could affect the assessments.
- •In the judgement of the investigator or medically qualified designee, any condition or medication which is causing cause Xerostomia.
- •Diabetes Mellitus.
- •Susceptibility to acid regurgitation.
- •Be susceptible to high dental erosion after drinking acidic soft drinks or juices
- •General Dental Exclusions
- •Any orthodontic appliances, restorations, bridgework or dentures that would interfere with the study evaluations or scheduled for such treatment within the timescale of the study.
- •Recurrent or regular aphthous ulcers.
Outcomes
Primary Outcomes
changes in enamel surface topography using an impression methodology with scanning electron microscopy
Time Frame: 6 hours
Secondary Outcomes
- changes in enamel surface topography using an impression methodology with scanning electron microscopy(2 hours)