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| Name | Class |
|---|---|
| University of Bristol Dental Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RS01 | Experimental | oral care product containing containing sodium monofluorophosphate and sodium fluoride |
|
| Water | Placebo Comparator | Water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RS01 | Other | Oral Care product containing sodium monofluorophosphate and sodium fluoride |
| |
| Measure | Description | Time Frame |
|---|---|---|
| changes in enamel surface topography using an impression methodology with scanning electron microscopy | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| changes in enamel surface topography using an impression methodology with scanning electron microscopy | 2 hours |
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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.
Diagnosis:
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.
Disease
General Dental Exclusions
Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Clinical Study/Experimental Medication
Substance abuse Recent history (within the last year) of alcohol or other substance abuse.
Personnel An employee of the sponsor, member of the study site or a staff family relative. The site for this protocol is the Clinical Trials Unit in the Bristol Dental School and Hospital. Employees of the Bristol Dental School and Hospital not associated with the Clinical Trials Unit are eligible to participate.
Any participant who, in the judgement of the investigator, should not participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Nicola X West, BDS | University of Bristol Dental Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Oral and Dental Science | Bristol | BS1 2LY | United Kingdom |
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| ID | Term |
|---|---|
| D014077 | Tooth Erosion |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D057085 | Tooth Wear |
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| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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| Water |
| Other |
|
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |