Intra Oral Kinetics of Fluoride Containing Dentifrices

Not Applicable

Completed

Interventions: Other: Comparator Dentifrice
Other: Test Dentifrice
Other: Reference Dentifrice
Other: Orange Juice
Other: De-ionised water

Brief Summary: 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.

Recruitment & Eligibility

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:
1. No clinically significant and relevant abnormalities of medical history or oral examination
2. 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.

Arm && Interventions

Group	Intervention	Description
Test dentifrice	Orange Juice	1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
Comparator dentifrice	Comparator Dentifrice	1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
Test dentifrice	De-ionised water	1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
Test dentifrice	Test Dentifrice	1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
Reference dentifrice	Reference Dentifrice	1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
Reference dentifrice	De-ionised water	1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
Comparator dentifrice	Orange Juice	1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
Comparator dentifrice	De-ionised water	1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse

Primary Outcome Measures

Name	Time	Method
Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse	60 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse	up to 60 minutes	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
Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse	60 minutes	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
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	up to 60 minutes	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

Locations (1): GSK Investigational Site
🇬🇧
Ellesmere Port, Cheshire, United Kingdom