Intra Oral Kinetics of Fluoride Containing Dentifrices

Study Overview
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Brief Summary
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The aim of this study is to assess the impact of formulation differences on fluoride retention clearance with US levels of fluoride (1150 ppm of fluoride) by evaluating and comparing between treatments the concentrations of fluoride and calcium ions in saliva over 60 minutes after a single brushing with US marketed fluoridated dentifrices and following a dietary acid challenge post 60 minutes of brushing with study treatment.

Official Title
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Intra-oral Kinetics of Fluoride Containing Dentifrices in a Modified Saliva Clearance Study

Conditions
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Tooth Erosion

Intervention / Treatment
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* Other: Test Dentifrice
* Other: Reference Dentifrice
* Other: Comparator Dentifrice
* Other: Orange Juice
* Other: De-ionised water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form Aged 18-65 years Understands and is willing, able and likely to comply with all study procedures and restrictions Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities of medical history or oral examination Absence of any condition that would impact on the participant's safety or well being or affect the individual's ability to understand and follow study procedures and requirements A minimum of 20 permanent natural teeth A gum-base stimulated whole saliva flow rate ≥ 0.8 mL/min and an unstimulated whole saliva flow rate ≥ 0.5 mL/min. Exclusion Criteria: Pregnant or breast feeding women Presence of chronic debilitating disease. Any condition that causes xerostomia as determined by the Investigator. Evidence of untreated caries. Gross periodontal disease. Tongue or lip piercing or presence of dental implants. Professional tooth cleaning or dental treatment during study. Oral surgery or extraction within 6 weeks of the screening visit. Self reported oral symptoms including lesions, sores or inflammation Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients Currently taking antibiotics or have taken antibiotics within 2 weeks of the screening visit Any medication that could affect salivary flow or cause xerostomia as determined by the Investigator Use of multivitamins, calcium supplements and or fluoride supplements within 7 days of treatment phase Participant unwilling to abstain from smoking for at least 4 hours on the day of each test visit Recent history (within the last year) of alcohol or other substance abuse.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Test dentifrice<br>1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse | Other: Test Dentifrice<br>* Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3<br>Other: Orange Juice<br>* Teeth will be rinsed with orange juice followed by rinsing with de-ionised water in test dentifrice and comparator dentifrice arms.<br>Other: De-ionised water<br>* Teeth will be rinsed with de-ionised water followed by reference dentifrice and followed by rinsing with orange juice in test dentifrice and comparator dentifrice arms.<br>|
| Other: Reference dentifrice<br>1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse | Other: Reference Dentifrice<br>* Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3<br>Other: De-ionised water<br>* Teeth will be rinsed with de-ionised water followed by reference dentifrice and followed by rinsing with orange juice in test dentifrice and comparator dentifrice arms.<br>|
| Other: Comparator dentifrice<br>1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse | Other: Comparator Dentifrice<br>* Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3<br>Other: Orange Juice<br>* Teeth will be rinsed with orange juice followed by rinsing with de-ionised water in test dentifrice and comparator dentifrice arms.<br>Other: De-ionised water<br>* Teeth will be rinsed with de-ionised water followed by reference dentifrice and followed by rinsing with orange juice in test dentifrice and comparator dentifrice arms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse | Concentration of fluoride ions in saliva at 60 minutes after a single brushing with a fluoride dentifrice prior to rinsing with either de-ionised (DI) water or orange juice (OJ). Descriptive data is presented as least square (LS) mean and standard error (SE). SE for Fluoride is the SE of the raw mean. | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Concentration of fluoride and calcium ions in saliva at baseline, 1, 5, 10, 15, 30 and 60 minutes (for calcium only) after a single brushing with a fluoride dentifrice | up to 60 minutes | 
| Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse | Concentration of fluoride and calcium ions in saliva following a rinse with either de ionised water or OJ 60 minutes after a single brushing with a fluoride dentifrice | 60 minutes | 
| Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse | Concentration of fluoride and calcium ions in the initial expectorate, de-ionized water rinse post brushing expectorate, and 60 minutes post brushing following administration of orange juice or de-ionised water rinse | up to 60 minutes |