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Intra Oral Kinetics of Fluoride Containing Dentifrices

Primary Purpose

Tooth Erosion

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Test Dentifrice

Reference Dentifrice

Comparator Dentifrice

Orange Juice

De-ionised water

About this trial

This is an interventional basic science trial for Tooth Erosion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Test dentifrice

Reference dentifrice

Comparator dentifrice

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse

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

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

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

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

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

Full Information

NCT ID

NCT02548156

First Posted

September 10, 2015

Last Updated

January 16, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT02548156

Brief Title

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

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

September 2015 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tooth Erosion

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test dentifrice

Arm Type

Other

Arm Description

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

Arm Title

Reference dentifrice

Arm Type

Other

Arm Description

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

Arm Title

Comparator dentifrice

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Test Dentifrice

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Reference Dentifrice

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Comparator Dentifrice

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Orange Juice

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

De-ionised water

Intervention Description

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 Outcome Measure Information:

Title

Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse

Description

Time Frame

60 minutes

Secondary Outcome Measure Information:

Title

Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse

Description

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

Time Frame

up to 60 minutes

Title

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

Description

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

Time Frame

60 minutes

Title

Description

Time Frame

up to 60 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Ellesmere Port

State/Province

Cheshire

ZIP/Postal Code

CH65 4BW

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Intra Oral Kinetics of Fluoride Containing Dentifrices

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