Trial Outcomes & Findings for In Situ Comparison of the Remineralization Potential of Optimized Fluoride Dentifrice With Control Fluoride Dentifrice (NCT NCT06010732)
NCT ID: NCT06010732
Last Updated: 2025-06-15
Results Overview
The SMH test was used to assess changes in the mineral status of partially demineralized enamel specimens. %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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
52 participants
Primary outcome timeframe
at the end of each two-week treatment per
Results posted on
2025-06-15
Participant Flow
Participant milestones
| Measure |
Test-Positive-Placebo
Crossover design - Cleaning, 2-3 day non-Fluoride (F) dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride Test Product,1100 ppm F as sodium fluoride (positive control) , 0 ppm F (placebo, negative control)
|
Test-Placebo-Positive
Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride Test Product, 0 ppm F (placebo, negative control),1100 ppm F as sodium fluoride (positive control)
|
Positive-Test-Placebo
Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product, 0 ppm F (placebo, negative control)
|
Positive-Placebo-Test
Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride (positive control), 0 ppm F (placebo, negative control), 1100 ppm F as sodium fluoride Test Product
|
Placebo-Test-Positive
Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 0 ppm F (placebo, negative control), 1100 ppm F as sodium fluoride Test Product,1100 ppm F as sodium fluoride (positive control)
|
Placebo-Positive-Test
Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 0 ppm F (placebo, negative control),1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product
|
|---|---|---|---|---|---|---|
|
Crossover Period 1
STARTED
|
9
|
8
|
9
|
9
|
8
|
9
|
|
Crossover Period 1
COMPLETED
|
9
|
8
|
8
|
9
|
7
|
9
|
|
Crossover Period 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Washout Between Periods 1 and 2
STARTED
|
9
|
8
|
8
|
9
|
7
|
9
|
|
Washout Between Periods 1 and 2
COMPLETED
|
9
|
7
|
8
|
9
|
7
|
9
|
|
Washout Between Periods 1 and 2
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Crossover Period 2
STARTED
|
9
|
7
|
8
|
9
|
7
|
9
|
|
Crossover Period 2
COMPLETED
|
9
|
6
|
7
|
9
|
7
|
9
|
|
Crossover Period 2
NOT COMPLETED
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Washout Between Periods 2 and 3
STARTED
|
9
|
6
|
7
|
9
|
7
|
9
|
|
Washout Between Periods 2 and 3
COMPLETED
|
9
|
6
|
7
|
9
|
7
|
9
|
|
Washout Between Periods 2 and 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Crossover Period 3
STARTED
|
9
|
6
|
7
|
9
|
7
|
9
|
|
Crossover Period 3
COMPLETED
|
9
|
6
|
7
|
9
|
7
|
9
|
|
Crossover Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test-Positive-Placebo
Crossover design - Cleaning, 2-3 day non-Fluoride (F) dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride Test Product,1100 ppm F as sodium fluoride (positive control) , 0 ppm F (placebo, negative control)
|
Test-Placebo-Positive
Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride Test Product, 0 ppm F (placebo, negative control),1100 ppm F as sodium fluoride (positive control)
|
Positive-Test-Placebo
Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product, 0 ppm F (placebo, negative control)
|
Positive-Placebo-Test
Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride (positive control), 0 ppm F (placebo, negative control), 1100 ppm F as sodium fluoride Test Product
|
Placebo-Test-Positive
Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 0 ppm F (placebo, negative control), 1100 ppm F as sodium fluoride Test Product,1100 ppm F as sodium fluoride (positive control)
|
Placebo-Positive-Test
Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 0 ppm F (placebo, negative control),1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product
|
|---|---|---|---|---|---|---|
|
Crossover Period 1
Protocol Violation
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Washout Between Periods 1 and 2
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Crossover Period 2
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Crossover Period 2
broken denture
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
In Situ Comparison of the Remineralization Potential of Optimized Fluoride Dentifrice With Control Fluoride Dentifrice
Baseline characteristics by cohort
| Measure |
All Study Participants
n=52 Participants
This was a three-way crossover design:
0 ppm F (placebo, negative control;1100 ppm F as sodium fluoride (positive control); 1100 ppm F as sodium fluoride Test Product
|
|---|---|
|
Age, Continuous
|
70 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: at the end of each two-week treatment perPopulation: Analyses were performed using all available data.
The SMH test was used to assess changes in the mineral status of partially demineralized enamel specimens. %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.
Outcome measures
| Measure |
0 Ppm F (Placebo)
n=47 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
1100 Ppm F as Sodium Fluoride (Positive Control)
n=48 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
1100 Ppm F as Sodium Fluoride Test Product
n=49 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
|---|---|---|---|
|
Percent Surface Microhardness Recovery (%SMH Recovery)
|
24.4 Percent Surface Microhardness Recovery
Interval 19.3 to 29.5
|
51.6 Percent Surface Microhardness Recovery
Interval 46.5 to 56.7
|
51.5 Percent Surface Microhardness Recovery
Interval 46.5 to 56.6
|
SECONDARY outcome
Timeframe: at the end of each two-week treatment periodPopulation: Analyses were performed using all available data.
The microdrill enamel biopsy technique will be used to analyze the fluoride content of the partially demineralized enamel specimens. Each enamel specimen will be mounted perpendicular to the long axis of a drill bit attached to a specially designed microdrill and drilled to a depth of \~100 µm through the entire lesion (four cores per specimen). The diameter of the drill hole will be determined using a calibrated microscope interfaced with an image analysis system. 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
Outcome measures
| Measure |
0 Ppm F (Placebo)
n=47 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
1100 Ppm F as Sodium Fluoride (Positive Control)
n=48 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
1100 Ppm F as Sodium Fluoride Test Product
n=49 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
|---|---|---|---|
|
Enamel Fluoride Uptake (µg F/cm2)
|
1.99 µg F/cm2
Interval 1.72 to 2.3
|
10.32 µg F/cm2
Interval 8.93 to 11.93
|
11.45 µg F/cm2
Interval 9.92 to 13.22
|
SECONDARY outcome
Timeframe: at the end of each two-week treatment periodPopulation: Analyses were performed using all available data.
% 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
Outcome measures
| Measure |
0 Ppm F (Placebo)
n=47 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
1100 Ppm F as Sodium Fluoride (Positive Control)
n=48 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
1100 Ppm F as Sodium Fluoride Test Product
n=49 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
|---|---|---|---|
|
Percent Net Acid Resistance
|
2.6 Percent Net Acid Resistance
Interval -2.3 to 7.4
|
34.3 Percent Net Acid Resistance
Interval 29.5 to 39.1
|
37.4 Percent Net Acid Resistance
Interval 32.6 to 42.1
|
SECONDARY outcome
Timeframe: at the end of each two-week treatment periodPopulation: Analyses were performed using all available data.
% 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
Outcome measures
| Measure |
0 Ppm F (Placebo)
n=47 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
1100 Ppm F as Sodium Fluoride (Positive Control)
n=48 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
1100 Ppm F as Sodium Fluoride Test Product
n=49 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
|---|---|---|---|
|
Percentage Comparative Acid Resistance
|
20.27 Percentage Comparative Acid Resistance
Interval 16.26 to 24.43
|
16.40 Percentage Comparative Acid Resistance
Interval 12.55 to 20.39
|
13.51 Percentage Comparative Acid Resistance
Interval 9.78 to 17.36
|
SECONDARY outcome
Timeframe: at the end of each two-week treatment periodPopulation: Analyses were performed using all available data.
∆Z= \[(lesion depth x 87) - area under the curve\*\] calculated using Transverse Microradiography software program
Outcome measures
| Measure |
0 Ppm F (Placebo)
n=47 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
1100 Ppm F as Sodium Fluoride (Positive Control)
n=48 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
1100 Ppm F as Sodium Fluoride Test Product
n=49 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
|---|---|---|---|
|
Integrated Mineral Loss (∆Z)
|
998 Integrated Mineral Loss (∆Z)
Interval 917.0 to 1087.0
|
703 Integrated Mineral Loss (∆Z)
Interval 646.0 to 765.0
|
708 Integrated Mineral Loss (∆Z)
Interval 651.0 to 770.0
|
SECONDARY outcome
Timeframe: at the end of each two-week treatment periodPopulation: Analyses were performed using all available data.
Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel) determined using Transverse Microradiography software program
Outcome measures
| Measure |
0 Ppm F (Placebo)
n=47 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
1100 Ppm F as Sodium Fluoride (Positive Control)
n=48 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
1100 Ppm F as Sodium Fluoride Test Product
n=49 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
|---|---|---|---|
|
Lesion Depth (µm)
|
40.5 µm
Interval 37.2 to 44.1
|
31.2 µm
Interval 28.7 to 33.9
|
30.6 µm
Interval 28.1 to 33.2
|
SECONDARY outcome
Timeframe: at the end of each two-week treatment periodPopulation: Analyses were performed using all available data.
SZmax was determined using Transverse Microradiography software program
Outcome measures
| Measure |
0 Ppm F (Placebo)
n=47 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
1100 Ppm F as Sodium Fluoride (Positive Control)
n=48 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
1100 Ppm F as Sodium Fluoride Test Product
n=49 Participants
Each subject used this product during one of the three treatment periods in the crossover study design.
|
|---|---|---|---|
|
Maximum Mineral Density at the Surface-zone (SZmax)
|
59.26 Maximum mineral density at the surface-z
Interval 57.4 to 61.12
|
66.17 Maximum mineral density at the surface-z
Interval 64.32 to 68.01
|
65.61 Maximum mineral density at the surface-z
Interval 63.79 to 67.44
|
Adverse Events
0 Ppm F (Placebo)
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
1100 Ppm F as Sodium Fluoride (Positive Control)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
1100 Ppm F as Sodium Fluoride Test Product
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0 Ppm F (Placebo)
n=52 participants at risk
Each subject used this product during one of the three treatment periods in the crossover study design.
|
1100 Ppm F as Sodium Fluoride (Positive Control)
n=52 participants at risk
Each subject used this product during one of the three treatment periods in the crossover study design.
|
1100 Ppm F as Sodium Fluoride Test Product
n=52 participants at risk
Each subject used this product during one of the three treatment periods in the crossover study design.
|
|---|---|---|---|
|
Gastrointestinal disorders
Bowel Obstructiion
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
|
Nervous system disorders
Migraine vestibulaire
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
1.9%
1/52 • Number of events 1 • 5 months
|
Other adverse events
| Measure |
0 Ppm F (Placebo)
n=52 participants at risk
Each subject used this product during one of the three treatment periods in the crossover study design.
|
1100 Ppm F as Sodium Fluoride (Positive Control)
n=52 participants at risk
Each subject used this product during one of the three treatment periods in the crossover study design.
|
1100 Ppm F as Sodium Fluoride Test Product
n=52 participants at risk
Each subject used this product during one of the three treatment periods in the crossover study design.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Flu
|
0.00%
0/52 • 5 months
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
1.9%
1/52 • Number of events 1 • 5 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
1.9%
1/52 • Number of events 1 • 5 months
|
|
Nervous system disorders
Cold Sweats
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
1.9%
1/52 • Number of events 1 • 5 months
|
|
Nervous system disorders
Lack of balance
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
1.9%
1/52 • Number of events 1 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Common cold
|
5.8%
3/52 • Number of events 3 • 5 months
|
9.6%
5/52 • Number of events 5 • 5 months
|
3.8%
2/52 • Number of events 2 • 5 months
|
|
Gastrointestinal disorders
Erythema Mandibular Ridge
|
3.8%
2/52 • Number of events 2 • 5 months
|
5.8%
3/52 • Number of events 3 • 5 months
|
3.8%
2/52 • Number of events 2 • 5 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
|
General disorders
Dehydration
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
|
Gastrointestinal disorders
Prolonged Post Operative Lleus
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
|
Skin and subcutaneous tissue disorders
Dry, cracked lower lip
|
0.00%
0/52 • 5 months
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
|
Gastrointestinal disorders
Burning Sensation Oral Cavity
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
1.9%
1/52 • Number of events 1 • 5 months
|
|
Gastrointestinal disorders
Transient Sour Sensation in Oral Cavity
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
|
Nervous system disorders
Sciatica Nerve Pain
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
|
Infections and infestations
Kidney Infection
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
|
Product Issues
Fractured Metal Frame of the Mandibular Partial
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
1.9%
1/52 • Number of events 1 • 5 months
|
|
Ear and labyrinth disorders
Earache
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
1.9%
1/52 • Number of events 1 • 5 months
|
|
Gastrointestinal disorders
Oral ulcer
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
3.8%
2/52 • Number of events 2 • 5 months
|
|
Skin and subcutaneous tissue disorders
Herpetic Lesion Upper Lip
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
|
Infections and infestations
Sore throat
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
|
Skin and subcutaneous tissue disorders
Dry and Chapped Lower Lip
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
|
Skin and subcutaneous tissue disorders
Swollen Lower Lip
|
0.00%
0/52 • 5 months
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
|
Gastrointestinal disorders
Tenderness Oral Cavity
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
1.9%
1/52 • Number of events 1 • 5 months
|
|
Nervous system disorders
Sinus Headache
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
1.9%
1/52 • Number of events 1 • 5 months
|
|
Skin and subcutaneous tissue disorders
Basel cell carcinoma
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
1.9%
1/52 • Number of events 1 • 5 months
|
|
Infections and infestations
Bladder Infection
|
0.00%
0/52 • 5 months
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Worsening of the lower back pain
|
0.00%
0/52 • 5 months
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
|
Gastrointestinal disorders
Erythema, Hard palate
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
1.9%
1/52 • Number of events 1 • 5 months
|
|
Gastrointestinal disorders
Pain anterior gingiva
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
|
Gastrointestinal disorders
Erythema buccal mucosa due to cheek bite
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
3.8%
2/52 • Number of events 2 • 5 months
|
|
General disorders
Body ache from shingle vaccine
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Worsening of COPD symptoms
|
0.00%
0/52 • 5 months
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Worsening of Asthma symptoms
|
0.00%
0/52 • 5 months
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Strain
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
|
General disorders
Worsening of Chest Pain
|
0.00%
0/52 • 5 months
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Stuffy nose
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
|
Nervous system disorders
Headache
|
1.9%
1/52 • Number of events 1 • 5 months
|
0.00%
0/52 • 5 months
|
0.00%
0/52 • 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place