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Completed

NCT Number: NCT02548156

Intra Oral Kinetics of Fluoride Containing Dentifrices

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.

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Key information

Conditions

Tooth Erosion Stomatognathic Diseases Tooth Demineralization Tooth Diseases Tooth Wear

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GSK Investigational Site

Ellesmere Port, Cheshire, CH65 4BW, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

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.

Treatment and study plan

Test Dentifrice

Other

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

Reference Dentifrice

Other

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

Comparator Dentifrice

Other

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

Orange juice

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

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.

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

    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 outcomes

  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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Intra-oral Kinetics of Fluoride Containing Dentifrices in a Modified Saliva Clearance Study

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 14, 2015
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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