Evaluation of the Fluoride Dose Response Using In Situ Caries Model
Sponsor
Procter and Gamble (Industry)
Overall Status
Completed
CT.gov ID
NCT04763044
Collaborator
(none)
15
1
5
4.7
3.2
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the fluoride dose response of different dentifrice fluoride concentrations - 0, 250, 1100 and 2800 ppm fluoride as sodium monofluorophosphate (MFP) and a fifth leg of 1100 ppm Stannous Fluoride (SnF2) using an in situ caries model.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
15 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Fifth leg of the study will not be randomized, participants will remain blinded but all will use the same product.
Primary Purpose:
Other
Official Title:
Evaluation of the Fluoride Dose Response of MFP Dentifrice Using In Situ Caries Model
Actual Study Start Date
:
Mar 1, 2021
Actual Primary Completion Date
:
Jul 21, 2021
Actual Study Completion Date
:
Jul 21, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Period 1 0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control) |
Drug: 0 ppm F
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 250 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 1100 ppm as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 2800 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
|
| Other: Period 2 0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control) |
Drug: 0 ppm F
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 250 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 1100 ppm as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 2800 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
|
| Other: Period 3 0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control) |
Drug: 0 ppm F
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 250 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 1100 ppm as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 2800 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
|
| Other: Period 4 0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control) |
Drug: 0 ppm F
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 250 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 1100 ppm as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 2800 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
|
| Other: Period 5 1100 ppm SnF2 toothpaste only |
Drug: 1100 ppm SnF2
Each subject will be assigned to this treatment during the fifth period for this crossover study.
|
Outcome Measures
Primary Outcome Measures
- Enamel Fluoride Uptake (EFU) [Evaluations will occur after 21 days of product use]
The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by [Sakkab et al., 1984]. The calculated scores will be measured in μg F/cm2.
Secondary Outcome Measures
- Enamel Fluoride Uptake (EFU) [Evaluations will occur after 7 days of product use]
The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by [Sakkab et al., 1984]. The calculated scores will be measured in μg F/cm2.
- Percent Surface Microhardness (SMH) [Evaluations will occur after 7 days of product use]
The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent.
- Enamel Fluoride Uptake (EFU) [Evaluations will occur after 14 days of product use]
The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by [Sakkab et al., 1984]. The calculated scores will be measured in μg F/cm2.
- Percent Surface Microhardness (SMH) [Evaluations will occur after 14 days of product use]
The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent.
- Percent Surface Microhardness (SMH) [Evaluations will occur after 21 days of product use]
The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Be between 18 and 85 years of age;
-
Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
-
Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
-
Be wearing a removable mandibular partial denture with sufficient room in one posterior buccal flange area to accommodate two 4 mm round enamel specimens 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), three-week treatment periods;
-
Be willing to allow study personnel to drill specimen sites (as described in #iv) 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 being pregnant, intending to become pregnant during the study period, or breast feeding;
-
Currently having any medical condition that could be expected to interfere with the subject's safety during the study period;
-
Currently taking antibiotics or having taken antibiotics in the two weeks prior to beginning treatment 1;
-
Having participated in another clinical study or receipt of an investigational drug within 30 days of beginning treatment 1; or
-
Taking fluoride supplements, required to use a fluoride mouth rinse, or have received a professional fluoride treatment in the two weeks preceding specimen placement;
-
Currently taking or have ever taken bisphosphonate drugs (e.g., Fosamax, Actonel and Boniva) for the treatment of osteoporosis.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oral Health Research Institute | Indianapolis | Indiana | United States | 46202 |
Sponsors and Collaborators
- Procter and Gamble
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT04763044
Other Study ID Numbers:
- 2020154
First Posted:
Feb 21, 2021
Last Update Posted:
Jul 19, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 0 Ppm MFP, 250 Ppm MFP, 1100 Ppm MFP, 2800 Ppm MFP, 1100 Ppm SnF2 | 250 Ppm MFP, 2800 Ppm MFP, 0 Ppm MFP, 1100 Ppm MFP, 1100 Ppm SnF2 | 1100 Ppm MFP, 0 Ppm MFP, 2800 Ppm MFP, 250 Ppm MFP, 1100 Ppm SnF2 | 2800 Ppm MFP, 1100 Ppm MFP, 250 Ppm MFP, 0 Ppm MFP, 1100 Ppm SnF2 |
|---|---|---|---|---|
| Arm/Group Description | This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 0, 250, 1100 and 2800 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2. | This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 250, 2800, 0, and 1100 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2. | This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 1100, 0, 2800 and 250 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2. | This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 2800, 1100, 250 and 0 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2. |
| Period Title: Period 1 | ||||
| STARTED | 3 | 4 | 4 | 4 |
| COMPLETED | 3 | 4 | 4 | 3 |
| NOT COMPLETED | 0 | 0 | 0 | 1 |
| Period Title: Period 1 | ||||
| STARTED | 3 | 4 | 4 | 3 |
| COMPLETED | 3 | 4 | 4 | 3 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
| Period Title: Period 1 | ||||
| STARTED | 3 | 4 | 4 | 3 |
| COMPLETED | 3 | 4 | 4 | 3 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
| Period Title: Period 1 | ||||
| STARTED | 3 | 3 | 4 | 3 |
| COMPLETED | 3 | 3 | 4 | 3 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
| Period Title: Period 1 | ||||
| STARTED | 3 | 3 | 4 | 3 |
| COMPLETED | 2 | 3 | 4 | 3 |
| NOT COMPLETED | 1 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | 0 Ppm MFP, 250 Ppm MFP, 1100 Ppm MFP, 2800 Ppm MFP, 1100 Ppm SnF2 | 250 Ppm MFP, 2800 Ppm MFP, 0 Ppm MFP, 1100 Ppm MFP, 1100 Ppm SnF2 | 1100 Ppm MFP, 0 Ppm MFP, 2800 Ppm MFP, 250 Ppm MFP, 1100 Ppm SnF2 | 2800 Ppm MFP, 1100 Ppm MFP, 250 Ppm MFP, 0 Ppm MFP, 1100 Ppm SnF2 | Total |
|---|---|---|---|---|---|
| Arm/Group Description | This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 0, 250, 1100 and 2800 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2. | This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 250, 2800, 0 and 1100 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2. | This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 1100, 0, 2800 and 250 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2. | This was a 4-way crossover design study. All participants were randomized to receive the following interventions in this order: 2800, 1100, 250 and 0 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model. Participants were additionally invited to participate in a fifth leg which contained 1100 ppm SnF2. | Total of all reporting groups |
| Overall Participants | 3 | 4 | 4 | 4 | 15 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
69.7
(8.33)
|
72.5
(4.51)
|
69.7
(9.50)
|
76.3
(9.32)
|
72.2
(7.75)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
1
33.3%
|
2
50%
|
4
100%
|
2
50%
|
9
60%
|
| Male |
2
66.7%
|
2
50%
|
0
0%
|
2
50%
|
6
40%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
2
50%
|
3
75%
|
4
100%
|
9
60%
|
| White |
2
66.7%
|
2
50%
|
1
25%
|
0
0%
|
5
33.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
33.3%
|
0
0%
|
0
0%
|
0
0%
|
1
6.7%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||||
| Count of Participants [Participants] |
0
0%
|
||||
| Region of Enrollment (participants) [Number] | |||||
| United States |
3
100%
|
4
100%
|
4
100%
|
4
100%
|
15
100%
|
Outcome Measures
| Title | Enamel Fluoride Uptake (EFU) |
|---|---|
| Description | The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by [Sakkab et al., 1984]. The calculated scores will be measured in μg F/cm2. |
| Time Frame | Evaluations will occur after 21 days of product use |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 0 Ppm F (Placebo, Negative Control) | 250 Ppm F as MFP (Dose-response Control) | 1100 Ppm F as MFP (Reference) | 2800 Ppm F as MFP (Dose-response Control) | 1100 Ppm SnF2 |
|---|---|---|---|---|---|
| Arm/Group Description | Each subject was randomly assigned to 0 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 250 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 1100 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 2800 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was assigned to 1100 ppm SnF2 dentifrice during the fifth period for this study. |
| Measure Participants | 14 | 14 | 13 | 14 | 12 |
| Mean (Standard Error) [μg F/cm^2] |
2.28
(0.709)
|
4.51
(0.709)
|
8.78
(0.736)
|
14.05
(0.709)
|
7.43
(0.423)
|
| Title | Enamel Fluoride Uptake (EFU) |
|---|---|
| Description | The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by [Sakkab et al., 1984]. The calculated scores will be measured in μg F/cm2. |
| Time Frame | Evaluations will occur after 7 days of product use |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 0 Ppm F (Placebo, Negative Control) | 250 Ppm F as MFP (Dose-response Control) | 1100 Ppm F as MFP (Reference) | 2800 Ppm F as MFP (Dose-response Control) | 1100 Ppm SnF2 |
|---|---|---|---|---|---|
| Arm/Group Description | Each subject was randomly assigned to 0 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 250 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 1100 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 2800 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was assigned to 1100 ppm SnF2 dentifrice during the fifth period for this study. |
| Measure Participants | 14 | 14 | 13 | 14 | 13 |
| Mean (Standard Error) [μg F/cm^2] |
3.13
(0.881)
|
5.20
(0.882)
|
8.20
(0.916)
|
13.52
(0.850)
|
9.11
(0.670)
|
| Title | Percent Surface Microhardness (SMH) |
|---|---|
| Description | The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent. |
| Time Frame | Evaluations will occur after 7 days of product use |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 0 Ppm F (Placebo, Negative Control) | 250 Ppm F as MFP (Dose-response Control) | 1100 Ppm F as MFP (Reference) | 2800 Ppm F as MFP (Dose-response Control) | 1100 Ppm SnF2 |
|---|---|---|---|---|---|
| Arm/Group Description | Each subject was randomly assigned to 0 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 250 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 1100 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 2800 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was assigned to 1100 ppm SnF2 dentifrice during the fifth period for this study. |
| Measure Participants | 14 | 14 | 13 | 14 | 13 |
| Mean (Standard Error) [Percent SMH Recovery] |
15.92
(3.259)
|
22.50
(3.264)
|
22.42
(3.360)
|
35.61
(3.160)
|
26.32
(4.605)
|
| Title | Enamel Fluoride Uptake (EFU) |
|---|---|
| Description | The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by [Sakkab et al., 1984]. The calculated scores will be measured in μg F/cm2. |
| Time Frame | Evaluations will occur after 14 days of product use |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 0 Ppm F (Placebo, Negative Control) | 250 Ppm F as MFP (Dose-response Control) | 1100 Ppm F as MFP (Reference) | 2800 Ppm F as MFP (Dose-response Control) | 1100 Ppm SnF2 |
|---|---|---|---|---|---|
| Arm/Group Description | Each subject was randomly assigned to 0 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 250 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 1100 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 2800 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was assigned to 1100 ppm SnF2 dentifrice during the fifth period for this study. |
| Measure Participants | 14 | 14 | 13 | 14 | 13 |
| Mean (Standard Error) [μg F/cm^2] |
3.86
(1.141)
|
7.23
(1.141)
|
11.53
(1.185)
|
18.92
(1.141)
|
12.65
(1.215)
|
| Title | Percent Surface Microhardness (SMH) |
|---|---|
| Description | The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent. |
| Time Frame | Evaluations will occur after 14 days of product use |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 0 Ppm F (Placebo, Negative Control) | 250 Ppm F as MFP (Dose-response Control) | 1100 Ppm F as MFP (Reference) | 2800 Ppm F as MFP (Dose-response Control) | 1100 Ppm SnF2 |
|---|---|---|---|---|---|
| Arm/Group Description | Each subject was randomly assigned to 0 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 250 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 1100 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 2800 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was assigned to 1100 ppm SnF2 dentifrice during the fifth period for this study. |
| Measure Participants | 14 | 14 | 13 | 14 | 13 |
| Mean (Standard Error) [Percent SMH Recovery] |
10.49
(4.258)
|
18.62
(4.258)
|
24.76
(4.369)
|
38.08
(4.258)
|
28.28
(4.562)
|
| Title | Percent Surface Microhardness (SMH) |
|---|---|
| Description | The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent. |
| Time Frame | Evaluations will occur after 21 days of product use |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 0 Ppm F (Placebo, Negative Control) | 250 Ppm F as MFP (Dose-response Control) | 1100 Ppm F as MFP (Reference) | 2800 Ppm F as MFP (Dose-response Control) | 1100 Ppm SnF2 |
|---|---|---|---|---|---|
| Arm/Group Description | Each subject was randomly assigned to 0 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 250 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 1100 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 2800 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was assigned to 1100 ppm SnF2 dentifrice during the fifth period for this study. |
| Measure Participants | 14 | 14 | 13 | 14 | 12 |
| Mean (Standard Error) [Percent SMH Recovery] |
4.76
(4.921)
|
11.14
(4.921)
|
17.51
(5.068)
|
33.38
(4.921)
|
17.91
(3.108)
|
Adverse Events
| Time Frame | Each participant was monitored throughout the whole study, up to 4 months. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | 0 Ppm F (Placebo, Negative Control) | 250 Ppm F as MFP (Dose-response Control) | 1100 Ppm F as MFP (Reference) | 2800 Ppm F as MFP (Dose-response Control) | 1100 Ppm SnF2 | |||||
| Arm/Group Description | Each subject was randomly assigned to 0 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 250 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 1100 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was randomly assigned to 2800 ppm F dentifrice during one of the four periods for this crossover study. | Each subject was assigned to 1100 ppm SnF2 dentifrice during the fifth period for this study. | |||||
All Cause Mortality |
||||||||||
| 0 Ppm F (Placebo, Negative Control) | 250 Ppm F as MFP (Dose-response Control) | 1100 Ppm F as MFP (Reference) | 2800 Ppm F as MFP (Dose-response Control) | 1100 Ppm SnF2 | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/14 (0%) | 0/14 (0%) | 0/13 (0%) | 0/14 (0%) | 0/13 (0%) | |||||
Serious Adverse Events |
||||||||||
| 0 Ppm F (Placebo, Negative Control) | 250 Ppm F as MFP (Dose-response Control) | 1100 Ppm F as MFP (Reference) | 2800 Ppm F as MFP (Dose-response Control) | 1100 Ppm SnF2 | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/14 (0%) | 0/14 (0%) | 0/13 (0%) | 0/14 (0%) | 0/13 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| 0 Ppm F (Placebo, Negative Control) | 250 Ppm F as MFP (Dose-response Control) | 1100 Ppm F as MFP (Reference) | 2800 Ppm F as MFP (Dose-response Control) | 1100 Ppm SnF2 | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/14 (21.4%) | 2/14 (14.3%) | 2/13 (15.4%) | 5/14 (35.7%) | 0/13 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Irritation Mouth | 1/14 (7.1%) | 1/14 (7.1%) | 0/13 (0%) | 0/14 (0%) | 0/13 (0%) | |||||
| Edentulous Ridge Erythmea | 1/14 (7.1%) | 0/14 (0%) | 0/13 (0%) | 0/14 (0%) | 0/13 (0%) | |||||
| Tooth Broken | 0/14 (0%) | 0/14 (0%) | 1/13 (7.7%) | 0/14 (0%) | 0/13 (0%) | |||||
| Irritation Gum | 0/14 (0%) | 0/14 (0%) | 0/13 (0%) | 1/14 (7.1%) | 0/13 (0%) | |||||
| Irritation Tongue | 0/14 (0%) | 0/14 (0%) | 0/13 (0%) | 1/14 (7.1%) | 0/13 (0%) | |||||
| Mouth Ulceration | 0/14 (0%) | 0/14 (0%) | 0/13 (0%) | 1/14 (7.1%) | 0/13 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Neck Pain | 0/14 (0%) | 0/14 (0%) | 1/13 (7.7%) | 0/14 (0%) | 0/13 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Renal Kidney Tumor | 0/14 (0%) | 0/14 (0%) | 0/13 (0%) | 1/14 (7.1%) | 0/13 (0%) | |||||
| Reproductive system and breast disorders | ||||||||||
| Vaginitis | 0/14 (0%) | 1/14 (7.1%) | 0/13 (0%) | 0/14 (0%) | 0/13 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Coughing | 1/14 (7.1%) | 0/14 (0%) | 0/13 (0%) | 0/14 (0%) | 0/13 (0%) | |||||
| Lung Cancer | 0/14 (0%) | 0/14 (0%) | 0/13 (0%) | 1/14 (7.1%) | 0/13 (0%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
PI should disclose plans to sponsor prior to public release.
Results Point of Contact
| Name/Title | Clinical Trial Manager |
|---|---|
| Organization | Procter & Gamble |
| Phone | 513-622-2489 |
| peters.j.2@pg.com |
Responsible Party:
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT04763044
Other Study ID Numbers:
- 2020154
First Posted:
Feb 21, 2021
Last Update Posted:
Jul 19, 2022
Last Verified:
Jun 1, 2022