Intra Oral Kinetics of Fluoride Containing Dentifrices

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Tooth Erosion

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02548156

204777

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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29 participants in 3 patient groups

Test dentifrice

Other group

Description:

1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse

Treatment:

Other: Test Dentifrice

Other: De-ionised water

Other: Orange Juice

Reference dentifrice

Other group

Description:

1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse

Treatment:

Other: De-ionised water

Other: Reference Dentifrice

Comparator dentifrice

Other group

Description:

1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse

Treatment:

Other: De-ionised water

Other: Orange Juice

Other: Comparator Dentifrice