Intra Oral Kinetics of Fluoride Containing Dentifrices

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Tooth Erosion	Other: Test Dentifrice; Other: Reference Dentifrice; Other: Comparator Dentifrice; Other: Orange Juice; Other: De-ionised water	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	29 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Basic Science
Official Title:	Intra-oral Kinetics of Fluoride Containing Dentifrices in a Modified Saliva Clearance Study
Study Start Date :	September 2015
Actual Primary Completion Date :	October 2015
Actual Study Completion Date :	October 2015

Arms and Interventions

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

Outcome Measures

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Primary Outcome Measures :

1. Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse [ Time Frame: 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 :

1. Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse [ Time Frame: 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
2. Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse [ Time Frame: 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
3. 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 [ Time Frame: 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

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Locations

United Kingdom
GSK Investigational Site
Ellesmere Port, Cheshire, United Kingdom, CH65 4BW

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT02548156 History of Changes
Other Study ID Numbers:	204777
First Posted:	September 14, 2015
Results First Posted:	July 27, 2016
Last Update Posted:	January 18, 2017
Last Verified:	January 2017

Additional relevant MeSH terms:

Tooth Erosion; Tooth Wear; Tooth Diseases; Stomatognathic Diseases	Fluorides; Cariostatic Agents; Protective Agents; Physiological Effects of Drugs