Clinical trial NCT02548156: Intra Oral Kinetics of Fluoride Containing Dentifrices
Official title: Intra-oral Kinetics of Fluoride Containing Dentifrices in a Modified Saliva Clearance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Erosion
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-09-14
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse
timeFrame: 60 minutes
Secondary outcomes:
measure: Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse
timeFrame: up to 60 minutes
measure: Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse
timeFrame: 60 minutes
measure: 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
timeFrame: up to 60 minutes
Other outcomes:
Locations:
city: Ellesmere Port
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: