Intra Oral Kinetics of Fluoride Containing Dentifrices

NCT02548156 | Completed Results

• 1 other identifier: 204777
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse

  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

  up to 60 minutes

Study Arms (3)

Test dentifrice

OTHER

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

Other: Test Dentifrice; Other: Orange Juice; Other: De-ionised water

Reference dentifrice

OTHER

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

Other: Reference Dentifrice; Other: De-ionised water

Comparator dentifrice

OTHER

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

Other: Comparator Dentifrice; Other: Orange Juice; Other: De-ionised water

Interventions

Test Dentifrice OTHER

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

Test dentifrice

Reference Dentifrice OTHER

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

Reference dentifrice

Comparator Dentifrice OTHER

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

Comparator dentifrice

Orange Juice OTHER

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

Comparator dentifrice; Test dentifrice

De-ionised water 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; Reference dentifrice; Test dentifrice

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Ellesmere Port, Cheshire, CH65 4BW, United Kingdom

Location

MeSH Terms

Conditions

Tooth Erosion

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: September 14, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 18, 2017
• Results First Posted: July 27, 2016

Record last verified: 2017-01

Locations

GB (1)