Evaluation of the Fluoride Dose Response of a Modified In... | NCT03383783 | Trialant
NCT03383783
Sponsor
Domenick Zero
Status
Completed
Last Update Posted
May 20, 2019Actual
Enrollment
28Actual
Phase
Phase 3
Conditions
Caries
Interventions
0 ppm F (placebo, negative control)
250 ppm F as NaF (dose-response control)
500 ppm F as NaF (dose-response control)
1100 ppm F as NaF (positive control)
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03383783
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
17-I-112
Secondary IDs
ID
Type
Description
Link
208705
Other Identifier
GlaxoSmithKline
Brief Title
Evaluation of the Fluoride Dose Response of a Modified In Situ Caries Model
Official Title
Evaluation of the Fluoride Dose Response of a Modified In Situ Caries Model
Acronym
Not provided
Organization
Indiana UniversityOTHER
Status Module
Record Verification Date
May 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 19, 2017Actual
Primary Completion Date
May 2, 2018Actual
Completion Date
May 2, 2018Actual
First Submitted Date
Dec 19, 2017
First Submission Date that Met QC Criteria
Dec 22, 2017
First Posted Date
Dec 26, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Apr 25, 2019
Results First Submitted that Met QC Criteria
May 16, 2019
Results First Posted Date
May 20, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 16, 2019
Last Update Posted Date
May 20, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Domenick Zero, Director, Oral Health Research Institute, Indiana UniversitySponsor-Investigator
Lead Sponsor
Domenick ZeroOTHER
Collaborators
Name
Class
GlaxoSmithKline
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the fluoride dose response of different dentifrice fluoride concentrations - 0, 250, 500 and 1100 ppm fluoride of our existing in situ model involving the use of human enamel specimens placed in the buccal flange area of the subjects partial denture with the modified model involving placement of bovine enamel specimens in a denture tooth location.
Detailed Description
This will be a double blind, single center, 4-way crossover design study involving 34 adult subjects, between the ages of 18 and 85 years. Two to three days before the start of each treatment period the subjects will have their teeth cleaned to remove all accessible plaque and calculus and will be provided with a non-fluoride dentifrice to use until their next visit. At the beginning of each testing period, two gauze-covered 4 × 4 mm partially demineralized human enamel specimens will be placed in the buccal flange area of the subject's mandibular partial denture. In addition, two gauze-covered 4 mm round partially demineralized bovine enamel specimens will be placed in the buccal surface of two posterior denture teeth of the same side of the partial denture. Once specimens are placed, subjects will wear their partial dentures twenty-four hours a day and use their assigned toothpaste twice daily, as instructed, until their next visit. Specimens will be removed after two weeks and the subjects will undergo a four to five day washout period followed by another cleaning and two to three day lead in period. This process will be repeated until all subjects have used all four test products. Changes in the mineral content of the enamel specimens will be assessed using the SMH and TMR. Enamel fluoride uptake (EFU) will be determined using the microdrill enamel biopsy technique. In addition the net acid resistance (NAR) and the comparative acid resistance (CAR) of the remineralized enamel specimens will be determined.
Conditions Module
Conditions
Caries
Keywords
Caries
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
28Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Treatment Period 1
Other
0 ppm F (placebo, negative control), 250 ppm F as NaF (dose-response control), 500 ppm F as NaF (dose-response control), 1100 ppm F as NaF (positive control)
Drug: 0 ppm F (placebo, negative control)
Drug: 250 ppm F as NaF (dose-response control)
Drug: 500 ppm F as NaF (dose-response control)
Drug: 1100 ppm F as NaF (positive control)
Treatment Period 2
Other
0 ppm F (placebo, negative control), 250 ppm F as NaF (dose-response control), 500 ppm F as NaF (dose-response control), 1100 ppm F as NaF (positive control)
Drug: 0 ppm F (placebo, negative control)
Drug: 250 ppm F as NaF (dose-response control)
Drug: 500 ppm F as NaF (dose-response control)
Drug: 1100 ppm F as NaF (positive control)
Treatment Period 3
Other
0 ppm F (placebo, negative control), 250 ppm F as NaF (dose-response control), 500 ppm F as NaF (dose-response control), 1100 ppm F as NaF (positive control)
Drug: 0 ppm F (placebo, negative control)
Drug: 250 ppm F as NaF (dose-response control)
Drug: 500 ppm F as NaF (dose-response control)
Drug: 1100 ppm F as NaF (positive control)
Treatment Period 4
Other
0 ppm F (placebo, negative control), 250 ppm F as NaF (dose-response control), 500 ppm F as NaF (dose-response control), 1100 ppm F as NaF (positive control)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
0 ppm F (placebo, negative control)
Drug
Each subject will use this product during one of the four treatment periods in the crossover study design.
Treatment Period 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage Surface Microhardness Recovery (%SMH)
The extent of remineralization will be calculated based on the method of [Gelhard et al., 1979].
SMH recovery = (D1-R)/(D1-B) ×100 B = indentation length (µm) of sound enamel specimen at baseline D1 = indentation length (µm) after in vitro demineralization R = indentation length (µm) after intra-oral exposure.
Enamel specimens will be evaluated after 14 days of intra-oral exposure
Secondary Outcomes
Measure
Description
Time Frame
Net Acid Resistance (NAR)
The %NAR will be calculated by the method of Corpron [Corpron et al., 1986]:
Net Acid Resistance = [(D1-D2) / (D1-B)] * 100 B= Indentation length (µm) of sound enamel at baseline D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization
Enamel specimens will be evaluated after 14 days of intra-oral exposure
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
provide voluntary, written informed consent;
be between 18 and 85 years old;
understand and be willing, able and likely to comply with all study procedures and restrictions;
be wearing a removable mandibular partial denture with sufficient room in one posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 × 7 mm) and room on the same side to accommodate two 4 mm round specimens in the buccal surface of two posterior denture teeth;
be willing and capable of wearing their removable partial denture 24 hours a day for four (4), two-week treatment periods;
be willing to allow study personnel to drill specimen sites (as described #4) in their mandibular partial denture;
be in good medical and dental health with no active caries or periodontal disease; NOTE; subjects presenting at screening with caries may continue in the study if their carious lesions are restored prior to beginning treatment 1.
have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min).
Exclusion Criteria:
currently be pregnant, intending to become pregnant during the study period or breast feeding;
currently have any medical condition that could be expected to interfere with the subject's safety during the study period;
currently be taking antibiotics or have taken antibiotics in the two weeks prior to the beginning treatment 1;
have participated in another clinical study or receipt of an investigational drug within 30 days of beginning treatment 1; or
be taking fluoride supplements, required to use a fluoride mouthrinse or have received a professional fluoride treatment in the two weeks preceding specimen placement;
be taking or have ever taken bisphosphonate drugs (e.g., Fosamax, Actonel and Boniva) for the treatment of osteoporosis;
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
85 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Domenick T Zero, DDS, MS
Indiana University
Principal Investigator
Anderson Hara, DDS, PhD
Indiana University
Principal Investigator
Frank Lippert, PhD
Indiana University
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Indiana University School of Dentistry, Oral Health Research Institute
Indianapolis
Indiana
46202
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
1 participant signed the informed consent and attended up to visit 2, but were dropped from the study as they no longer met inclusion criteria, and this occurred before randomization to interventions.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
All Study Participants
This was a 4-way crossover design study. All participants were randomized to receive the following interventions:
Dentifrice fluoride concentrations - 0, 250, 500 and 1100 ppm fluoride of our existing in situ model involving the use of human enamel specimens placed in the buccal flange area of the subjects partial denture with the modified model involving placement of bovine enamel specimens in a denture tooth location.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00027 subjects
COMPLETED
FG00025 subjects
NOT COMPLETED
FG0002 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
All Study Participants
This was a 4-way crossover design study. All participants were randomized to receive the following interventions:
Dentifrice fluoride concentrations - 0, 250, 500 and 1100 ppm fluoride of our existing in situ model involving the use of human enamel specimens placed in the buccal flange area of the subjects partial denture with the modified model involving placement of bovine enamel specimens in a denture tooth location.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage Surface Microhardness Recovery (%SMH)
The extent of remineralization will be calculated based on the method of [Gelhard et al., 1979].
SMH recovery = (D1-R)/(D1-B) ×100 B = indentation length (µm) of sound enamel specimen at baseline D1 = indentation length (µm) after in vitro demineralization R = indentation length (µm) after intra-oral exposure.
Posted
Mean
95% Confidence Interval
Percent Surface Microhardness Recovery
Enamel specimens will be evaluated after 14 days of intra-oral exposure
ID
Title
Description
OG000
Bovine Specimens 0 Ppm F
This arm group consisted of the two bovine specimens and 0 parts per million fluoride dentifrice.
OG001
Bovine Specimens 250 Ppm F
Adverse Events Module
Frequency Threshold
0
Time Frame
Each participant was monitored for a 3 month period.
Description
The collection/monitoring of adverse events started at visit 2 (prior to randomization), at which time there were 28 eligible subjects. Human and bovine specimens were both placed on the same side of the lower partial dentures in 27 subjects at visit 3 (randomization), and from that point forward adverse events were monitored based on the assigned treatment.
Sensodyne sodium fluoride/silica toothpaste base formulation
250 ppm F as NaF (dose-response control)
Drug
Each subject will use this product during one of the four treatment periods in the crossover study design.
Treatment Period 1
Treatment Period 2
Treatment Period 3
Treatment Period 4
Sensodyne sodium fluoride/silica toothpaste base formulation
500 ppm F as NaF (dose-response control)
Drug
Each subject will use this product during one of the four treatment periods in the crossover study design.
Treatment Period 1
Treatment Period 2
Treatment Period 3
Treatment Period 4
Sensodyne sodium fluoride/silica toothpaste base formulation
1100 ppm F as NaF (positive control)
Drug
Each subject will use this product during one of the four treatment periods in the crossover study design.
Treatment Period 1
Treatment Period 2
Treatment Period 3
Treatment Period 4
Sensodyne sodium fluoride/silica toothpaste base formulation
Comparative Acid Resistance (CAR)
Using the data from the four centrally located enamel specimens, the equation used will compare explicitly the reduction in SMH brought by the first and second acid challenges:
Comparative Acid Resistance = [(D2-R) / (D1-B)] * 100 B= Indentation length (µm) of sound enamel at baseline R= Indentation length (µm) of enamel after in situ remineralization D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization
Enamel specimens will be evaluated after 14 days of intra-oral exposure
Enamel Fluoride Uptake (EFU)
The amount of fluoride-uptake by enamel will be calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as µg F/cm2.
Enamel specimens will be evaluated after 14 days of intra-oral exposure
Transverse Microradiography (TMR) - Integrated Mineral Loss - ∆Z
Lesions will be analyzed after in situ demineralization and the following three parameters calculated:
Integrated Mineral Loss - ∆Z= [(lesion depth x 87) - area under the curve*]
Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel)
Maximum mineral density at the surface-zone - SZmax
Enamel specimens will be evaluated after 14 days of intra-oral exposure
Transverse Microradiography (TMR) - Lesion Depth - L
Lesions will be analyzed after in situ demineralization and the following three parameters calculated:
Integrated Mineral Loss - ∆Z= [(lesion depth x 87) - area under the curve*]
Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel)
Maximum mineral density at the surface-zone - SZmax
Enamel specimens will be evaluated after 14 days of intra-oral exposure
Transverse Microradiography (TMR) - Maximum Mineral Density at the Surface-zone
Lesions will be analyzed after in situ demineralization and the following three parameters calculated:
Integrated Mineral Loss - ∆Z= [(lesion depth x 87) - area under the curve*]
Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel)
Maximum mineral density at the surface-zone - SZmax (arbitrary unit from TMR software)
Enamel specimens will be evaluated after 14 days of intra-oral exposure
27
Full Range
Years
Title
Denominators
Categories
Title
Measurements
BG00067(37 to 85)
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00018
Male
BG0009
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG00012
White/African-American
BG0001
African-American
BG00014
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG00027
This arm group consisted of the two bovine specimens and 250 parts per million fluoride dentifrice.
OG002
Bovine Specimens 500 Ppm F
This arm group consisted of the two bovine specimens and 500 parts per million fluoride dentifrice.
OG003
Bovine Specimens 1100 Ppm F
This arm group consisted of the two bovine specimens and 1100 parts per million fluoride dentifrice.
OG004
Human Specimens 0 Ppm F
This arm group consisted of the two human specimens and 0 parts per million fluoride dentifrice.
OG005
Human Specimens 250 Ppm F
This arm group consisted of the two human specimens and 250 parts per million fluoride dentifrice.
OG006
Human Specimens 500 Ppm F
This arm group consisted of the two human specimens and 500 parts per million fluoride dentifrice.
OG007
Human Specimens 1100 Ppm F
This arm group consisted of the two human specimens and 1100 parts per million fluoride dentifrice.
Units
Counts
Participants
OG00027
OG00127
OG00227
OG00327
OG00427
OG00527
OG00627
OG00727
Title
Denominators
Categories
Title
Measurements
OG00013.96(8 to 20.29)
OG00130.59(22.26 to 38.71)
OG00240.74(31.68 to 50.34)
OG00348.28(37.15 to 57.86)
OG0047.42(2.55 to 12.45)
OG00516.27(10.33 to 22.51)
OG00621.59(13.67 to 29.64)
OG00726.75(18.19 to 35.29)
Secondary
Net Acid Resistance (NAR)
The %NAR will be calculated by the method of Corpron [Corpron et al., 1986]:
Net Acid Resistance = [(D1-D2) / (D1-B)] * 100 B= Indentation length (µm) of sound enamel at baseline D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization
Posted
Mean
95% Confidence Interval
% Net Acid Resistance
Enamel specimens will be evaluated after 14 days of intra-oral exposure
ID
Title
Description
OG000
Bovine Specimens 0 Ppm F
This arm group consisted of the two bovine specimens and 0 parts per million fluoride dentifrice.
OG001
Bovine Specimens 250 Ppm F
This arm group consisted of the two bovine specimens and 250 parts per million fluoride dentifrice.
OG002
Bovine Specimens 500 Ppm F
This arm group consisted of the two bovine specimens and 500 parts per million fluoride dentifrice.
OG003
Bovine Specimens 1100 Ppm F
This arm group consisted of the two bovine specimens and 1100 parts per million fluoride dentifrice.
OG004
Human Specimens 0 Ppm F
This arm group consisted of the two human specimens and 0 parts per million fluoride dentifrice.
OG005
Human Specimens 250 Ppm F
This arm group consisted of the two human specimens and 250 parts per million fluoride dentifrice.
OG006
Human Specimens 500 Ppm F
This arm group consisted of the two human specimens and 500 parts per million fluoride dentifrice.
OG007
Human Specimens 1100 Ppm F
This arm group consisted of the two human specimens and 1100 parts per million fluoride dentifrice.
Units
Counts
Participants
OG00027
OG00127
OG00227
OG003
Title
Denominators
Categories
Title
Measurements
OG000-22.68(-36.71 to -11.7)
OG00111.43(1.92 to 20.42)
OG00218.66(8.17 to 27.63)
OG003
Secondary
Comparative Acid Resistance (CAR)
Using the data from the four centrally located enamel specimens, the equation used will compare explicitly the reduction in SMH brought by the first and second acid challenges:
Comparative Acid Resistance = [(D2-R) / (D1-B)] * 100 B= Indentation length (µm) of sound enamel at baseline R= Indentation length (µm) of enamel after in situ remineralization D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization
Posted
Mean
95% Confidence Interval
% Comparative Acid Resistance
Enamel specimens will be evaluated after 14 days of intra-oral exposure
ID
Title
Description
OG000
Bovine Specimens 0 Ppm F
This arm group consisted of the two bovine specimens and 0 parts per million fluoride dentifrice.
OG001
Bovine Specimens 250 Ppm F
This arm group consisted of the two bovine specimens and 250 parts per million fluoride dentifrice.
OG002
Bovine Specimens 500 Ppm F
This arm group consisted of the two bovine specimens and 500 parts per million fluoride dentifrice.
OG003
Bovine Specimens 1100 Ppm F
This arm group consisted of the two bovine specimens and 1100 parts per million fluoride dentifrice.
OG004
Human Specimens 0 Ppm F
This arm group consisted of the two human specimens and 0 parts per million fluoride dentifrice.
OG005
Human Specimens 250 Ppm F
This arm group consisted of the two human specimens and 250 parts per million fluoride dentifrice.
OG006
Human Specimens 500 Ppm F
This arm group consisted of the two human specimens and 500 parts per million fluoride dentifrice.
OG007
Human Specimens 1100 Ppm F
This arm group consisted of the two human specimens and 1100 parts per million fluoride dentifrice.
Units
Counts
Participants
OG00027
OG00127
OG00227
OG003
Title
Denominators
Categories
Title
Measurements
OG00036.42(23.87 to 51.03)
OG00119.20(11.28 to 27.99)
OG00222.16(13 to 32.82)
OG003
Secondary
Enamel Fluoride Uptake (EFU)
The amount of fluoride-uptake by enamel will be calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as µg F/cm2.
Posted
Mean
95% Confidence Interval
µg F/cm^2
Enamel specimens will be evaluated after 14 days of intra-oral exposure
ID
Title
Description
OG000
Bovine Specimens 0 Ppm F
This arm group consisted of the two bovine specimens and 0 parts per million fluoride dentifrice.
OG001
Bovine Specimens 250 Ppm F
This arm group consisted of the two bovine specimens and 250 parts per million fluoride dentifrice.
OG002
Bovine Specimens 500 Ppm F
This arm group consisted of the two bovine specimens and 500 parts per million fluoride dentifrice.
OG003
Bovine Specimens 1100 Ppm F
This arm group consisted of the two bovine specimens and 1100 parts per million fluoride dentifrice.
OG004
Human Specimens 0 Ppm F
This arm group consisted of the two human specimens and 0 parts per million fluoride dentifrice.
OG005
Human Specimens 250 Ppm F
This arm group consisted of the two human specimens and 250 parts per million fluoride dentifrice.
OG006
Human Specimens 500 Ppm F
This arm group consisted of the two human specimens and 500 parts per million fluoride dentifrice.
OG007
Human Specimens 1100 Ppm F
This arm group consisted of the two human specimens and 1100 parts per million fluoride dentifrice.
Units
Counts
Participants
OG00027
OG00127
OG00227
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.96(0.73 to 1.16)
OG0012.25(1.94 to 2.56)
OG0022.69(2.35 to 2.97)
OG003
Secondary
Transverse Microradiography (TMR) - Integrated Mineral Loss - ∆Z
Lesions will be analyzed after in situ demineralization and the following three parameters calculated:
Integrated Mineral Loss - ∆Z= [(lesion depth x 87) - area under the curve*]
Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel)
Maximum mineral density at the surface-zone - SZmax
Posted
Mean
95% Confidence Interval
Integrated Mineral Loss - ∆Z
Enamel specimens will be evaluated after 14 days of intra-oral exposure
ID
Title
Description
OG000
Bovine Specimens 0 Ppm F
This arm group consisted of the two bovine specimens and 0 parts per million fluoride dentifrice.
OG001
Bovine Specimens 250 Ppm F
This arm group consisted of the two bovine specimens and 250 parts per million fluoride dentifrice.
OG002
Bovine Specimens 500 Ppm F
This arm group consisted of the two bovine specimens and 500 parts per million fluoride dentifrice.
OG003
Bovine Specimens 1100 Ppm F
This arm group consisted of the two bovine specimens and 1100 parts per million fluoride dentifrice.
OG004
Human Specimens 0 Ppm F
This arm group consisted of the two human specimens and 0 parts per million fluoride dentifrice.
OG005
Human Specimens 250 Ppm F
This arm group consisted of the two human specimens and 250 parts per million fluoride dentifrice.
OG006
Human Specimens 500 Ppm F
This arm group consisted of the two human specimens and 500 parts per million fluoride dentifrice.
OG007
Human Specimens 1100 Ppm F
This arm group consisted of the two human specimens and 1100 parts per million fluoride dentifrice.
Units
Counts
Participants
OG00027
OG00127
OG00227
OG003
Title
Denominators
Categories
Title
Measurements
OG0001240(948 to 1621)
OG001902(710 to 1136)
OG002664(546 to 803)
OG003
Secondary
Transverse Microradiography (TMR) - Lesion Depth - L
Lesions will be analyzed after in situ demineralization and the following three parameters calculated:
Integrated Mineral Loss - ∆Z= [(lesion depth x 87) - area under the curve*]
Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel)
Maximum mineral density at the surface-zone - SZmax
Posted
Mean
95% Confidence Interval
Micrometers
Enamel specimens will be evaluated after 14 days of intra-oral exposure
ID
Title
Description
OG000
Bovine Specimens 0 Ppm F
This arm group consisted of the two bovine specimens and 0 parts per million fluoride dentifrice.
OG001
Bovine Specimens 250 Ppm F
This arm group consisted of the two bovine specimens and 250 parts per million fluoride dentifrice.
OG002
Bovine Specimens 500 Ppm F
This arm group consisted of the two bovine specimens and 500 parts per million fluoride dentifrice.
OG003
Bovine Specimens 1100 Ppm F
This arm group consisted of the two bovine specimens and 1100 parts per million fluoride dentifrice.
OG004
Human Specimens 0 Ppm F
This arm group consisted of the two human specimens and 0 parts per million fluoride dentifrice.
OG005
Human Specimens 250 Ppm F
This arm group consisted of the two human specimens and 250 parts per million fluoride dentifrice.
OG006
Human Specimens 500 Ppm F
This arm group consisted of the two human specimens and 500 parts per million fluoride dentifrice.
OG007
Human Specimens 1100 Ppm F
This arm group consisted of the two human specimens and 1100 parts per million fluoride dentifrice.
Units
Counts
Participants
OG00027
OG00127
OG00227
OG003
Title
Denominators
Categories
Title
Measurements
OG00052.01(40.62 to 65.49)
OG00141.74(32.58 to 53.38)
OG00234.85(27.39 to 43.65)
OG003
Secondary
Transverse Microradiography (TMR) - Maximum Mineral Density at the Surface-zone
Lesions will be analyzed after in situ demineralization and the following three parameters calculated:
Integrated Mineral Loss - ∆Z= [(lesion depth x 87) - area under the curve*]
Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel)
Maximum mineral density at the surface-zone - SZmax (arbitrary unit from TMR software)
Posted
Mean
95% Confidence Interval
SZmax
Enamel specimens will be evaluated after 14 days of intra-oral exposure
ID
Title
Description
OG000
Bovine Specimens 0 Ppm F
This arm group consisted of the two bovine specimens and 0 parts per million fluoride dentifrice.
OG001
Bovine Specimens 250 Ppm F
This arm group consisted of the two bovine specimens and 250 parts per million fluoride dentifrice.
OG002
Bovine Specimens 500 Ppm F
This arm group consisted of the two bovine specimens and 500 parts per million fluoride dentifrice.
OG003
Bovine Specimens 1100 Ppm F
This arm group consisted of the two bovine specimens and 1100 parts per million fluoride dentifrice.
OG004
Human Specimens 0 Ppm F
This arm group consisted of the two human specimens and 0 parts per million fluoride dentifrice.
OG005
Human Specimens 250 Ppm F
This arm group consisted of the two human specimens and 250 parts per million fluoride dentifrice.
OG006
Human Specimens 500 Ppm F
This arm group consisted of the two human specimens and 500 parts per million fluoride dentifrice.
OG007
Human Specimens 1100 Ppm F
This arm group consisted of the two human specimens and 1100 parts per million fluoride dentifrice.
Units
Counts
Participants
OG00027
OG00127
OG00227
OG003
Title
Denominators
Categories
Title
Measurements
OG00062.17(59.59 to 64.44)
OG00162.54(60.14 to 65.14)
OG00267.13(63.53 to 70.61)
OG003
27
0
27
10
27
EG001
250 Ppm F
250 parts per million fluoride
0
27
0
27
5
27
EG002
500 Ppm F
500 parts per million fluoride
0
27
0
27
6
27
EG003
1100 Ppm F
1100 parts per million fluoride
0
27
0
27
5
27
EG004
Between Treatment Periods
Adverse Events that occurred between treatment periods.
0
27
0
27
7
27
EG005
Prior to Randomization
Adverse Events that occurred prior to a subject being randomized into the study.