Back to resultsClinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model
Primary Purpose
Dental Caries
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Toothpaste containing 1150ppm F
Toothpaste containing 0ppm F
Toothpaste containing 250ppm F
Toothpaste containing 1150ppm F
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries
Eligibility Criteria
Inclusion Criteria:
- Demonstrates understanding of the study.
- Aged 18 to 85 years.
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- Has good general health (in the opinion of the investigator or medically qualified designee).
- Currently living in the Indianapolis, Indiana area.
- Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens.
- Have no current active caries or periodontal disease and all restorations in a good state of repair.
- Have a salivary flow rate in the range of normal values.
Exclusion Criteria:
- Pregnant or breast feeding women.
- Known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients.
- Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit.
- Unable to measure product weights accurately using the assigned study scale as determined by the study staff as demonstrated.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Have received a professional fluoride treatment within 14 days of randomization to the first treatment.
- Recent history (within the last year) of alcohol or other substance abuse.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Test fluoride toothpaste
Fluoride free (0ppm F) reference control toothpaste
Low dose fluoride (250ppm F) reference control toothpaste
Fluoride (1150ppm F) reference control toothpaste
Arm Description
Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods
Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods.
Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods.
Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods.
Outcomes
Primary Outcome Measures
Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with a fluoride free reference control toothpaste
The change in mineral content (ΔM) of the lesions as measured by Transverse Microradiography (TMR) will be calculated by the following formula: ΔM= (Post-treatment ΔZ - baseline ΔZ)
Secondary Outcome Measures
Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with all other treatments
The change in mineral content (ΔM) of the lesions as measured by TMR will be calculated by the following formula: ΔM= (Post-treatment ΔZ - baseline ΔZ)
Changes in enamel lesion depth (ΔL) following use of the test toothpaste with all other treatments
The change in lesion depth (ΔL) as measured by TMR will be calculated by: ΔL= (Post-treatment lesion depth - baseline lesion depth)
Net change in surface zone mineral content (ΔSZmax) following use of the toothpaste with all other treatments
The change in SZmax (ΔSZmax) as measured by TMR will be calculated by: ΔSZmax= (Post-treatment SZmax - baseline SZmax)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02436473
Brief Title
Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model
Official Title
Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
This study was cancelled. No subjects were enrolled and no data has been collected
Study Start Date
December 2015 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of the test toothpaste containing 1150 parts per million (ppm) of fluoride (F) on the mineral content of demineralized enamel specimens, in an in situ caries model system, by comparing the differences in net remineralization change (ΔM) following use of the test toothpaste with a fluoride free (0 ppm F) reference control toothpaste.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test fluoride toothpaste
Arm Type
Experimental
Arm Description
Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods
Arm Title
Fluoride free (0ppm F) reference control toothpaste
Arm Type
Placebo Comparator
Arm Description
Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods.
Arm Title
Low dose fluoride (250ppm F) reference control toothpaste
Arm Type
Active Comparator
Arm Description
Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods.
Arm Title
Fluoride (1150ppm F) reference control toothpaste
Arm Type
Active Comparator
Arm Description
Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods.
Intervention Type
Drug
Intervention Name(s)
Toothpaste containing 1150ppm F
Intervention Description
US marketed toothpaste containing 1150ppm of F
Intervention Type
Other
Intervention Name(s)
Toothpaste containing 0ppm F
Intervention Description
Experimental toothpaste containing 0ppm F
Intervention Type
Drug
Intervention Name(s)
Toothpaste containing 250ppm F
Intervention Description
Experimental toothpaste containing 250ppm F
Intervention Type
Drug
Intervention Name(s)
Toothpaste containing 1150ppm F
Intervention Description
Experimental toothpaste containing 1150ppm F
Primary Outcome Measure Information:
Title
Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with a fluoride free reference control toothpaste
Description
The change in mineral content (ΔM) of the lesions as measured by Transverse Microradiography (TMR) will be calculated by the following formula: ΔM= (Post-treatment ΔZ - baseline ΔZ)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with all other treatments
Description
The change in mineral content (ΔM) of the lesions as measured by TMR will be calculated by the following formula: ΔM= (Post-treatment ΔZ - baseline ΔZ)
Time Frame
4 weeks
Title
Changes in enamel lesion depth (ΔL) following use of the test toothpaste with all other treatments
Description
The change in lesion depth (ΔL) as measured by TMR will be calculated by: ΔL= (Post-treatment lesion depth - baseline lesion depth)
Time Frame
4 weeks
Title
Net change in surface zone mineral content (ΔSZmax) following use of the toothpaste with all other treatments
Description
The change in SZmax (ΔSZmax) as measured by TMR will be calculated by: ΔSZmax= (Post-treatment SZmax - baseline SZmax)
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Demonstrates understanding of the study.
Aged 18 to 85 years.
Understands and is willing, able and likely to comply with all study procedures and restrictions.
Has good general health (in the opinion of the investigator or medically qualified designee).
Currently living in the Indianapolis, Indiana area.
Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens.
Have no current active caries or periodontal disease and all restorations in a good state of repair.
Have a salivary flow rate in the range of normal values.
Exclusion Criteria:
Pregnant or breast feeding women.
Known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients.
Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit.
Unable to measure product weights accurately using the assigned study scale as determined by the study staff as demonstrated.
Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
Have received a professional fluoride treatment within 14 days of randomization to the first treatment.
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
12. IPD Sharing Statement
Learn more about this trial
Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model
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