Intra Oral Kinetics of Fluoride Containing Dentifrices

NCT ID: NCT02548156

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2015-10-31

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.

Conditions

Tooth Erosion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Test dentifrice

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

Group Type: OTHER

Test Dentifrice

Intervention Type: OTHER

Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3

Orange Juice

Intervention Type: OTHER

Teeth will be rinsed with orange juice followed by rinsing with de-ionised water in test dentifrice and comparator dentifrice arms.

De-ionised water

Intervention Type: OTHER

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

Group Type: OTHER

Reference Dentifrice

Intervention Type: OTHER

Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3

De-ionised water

Intervention Type: OTHER

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

Group Type: OTHER

Comparator Dentifrice

Intervention Type: OTHER

Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3

Orange Juice

Intervention Type: OTHER

Teeth will be rinsed with orange juice followed by rinsing with de-ionised water in test dentifrice and comparator dentifrice arms.

De-ionised water

Intervention Type: OTHER

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.

Interventions

Test Dentifrice

Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3

Intervention Type: OTHER

Reference Dentifrice

Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3

Intervention Type: OTHER

Comparator Dentifrice

Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3

Intervention Type: OTHER

Orange Juice

Teeth will be rinsed with orange juice followed by rinsing with de-ionised water in test dentifrice and comparator dentifrice arms.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Ellesmere Port, Cheshire, United Kingdom

Countries

United Kingdom

Other Identifiers

204777

Identifier Type: -

Identifier Source: org_study_id