Trial Outcomes & Findings for An Erosion Study to Investigate the Efficacy of an Experimental Dentifrice to Remineralize Enamel (NCT NCT06242444)
NCT ID: NCT06242444
Last Updated: 2025-05-08
Results Overview
%SMHR was used to measure the ability of the dentifrice to remineralize enamel. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and the extent of remineralization was evaluated using surface microhardness (SMH) technique to yield the %SMHR. The enamel specimens were evaluated both prior to and after intra-oral exposure and indentation lengths were measured. The %SMHR was derived as \[(E1-R)/(E1-B)\] \* 100 where: B = indentation length (micrometre \[μm\]) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 hours in situ remineralization.
COMPLETED
NA
33 participants
At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)
2025-05-08
Participant Flow
This study was conducted at a single center in the United States.
A total of 34 participants were screened of which 33 participants were randomized as per crossover design to receive either one of the 6 treatment sequences: Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA where Treatment A=Test Dentifrice, Treatment B=Placebo Control Dentifrice, Treatment C=Reference Dentifrice. All 33 randomized participants completed the study.
Participant milestones
| Measure |
Sequence ABC (Test Dentifrice + Placebo Control Dentifrice + Reference Dentifrice)
Participants brushed the buccal surfaces of their natural teeth using 1.5+/-0.1 grams (g) of the Test Dentifrice containing 1150 parts per million (ppm) fluoride and 5 percent (%) potassium nitrate (KNO3) once on Day 1 of Treatment Period 1 (Treatment A) followed by 1.5+/-0.1 g of Placebo Control Dentifrice containing 0 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 2 (Treatment B) and further followed by 1.5+/-0.1 g of Reference Dentifrice containing 1100 ppm fluoride as stannous fluoride (SnF2) once on Day 1 of Treatment Period 3 (Treatment C). Participants used the assigned dentifrice under supervision of the study staff while the intraoral appliance was in place and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. There was a washout period of a minimum of 3 days prior to each treatment.
|
Sequence ACB (Test Dentifrice + Reference Dentifrice + Placebo Control Dentifrice)
Participants brushed the buccal surfaces of their natural teeth using 1.5+/-0.1 g of the Test Dentifrice containing 1150 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 1 (Treatment A) followed by 1.5+/-0.1 g of Reference Dentifrice containing 1100 ppm fluoride as SnF2 once on Day 1 of Treatment Period 2 (Treatment C) and further followed by 1.5+/-0.1 g of Placebo Control Dentifrice containing 0 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 3 (Treatment B). Participants used the assigned dentifrice under supervision of the study staff while the intraoral appliance was in place and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. There was a washout period of a minimum of 3 days prior to each treatment.
|
Sequence BAC (Placebo Control Dentifrice + Test Dentifrice + Reference Dentifrice)
Participants brushed the buccal surfaces of their natural teeth using 1.5+/-0.1 g of Placebo Control Dentifrice containing 0 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 1 (Treatment B) followed by 1.5+/-0.1 g of the Test Dentifrice containing 1150 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 2 (Treatment A) and further followed by 1.5+/-0.1 g of Reference Dentifrice containing 1100 ppm fluoride as SnF2 once on Day 1 of Treatment Period 3 (Treatment C). Participants used the assigned dentifrice under supervision of the study staff while the intraoral appliance was in place and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. There was a washout period of a minimum of 3 days prior to each treatment.
|
Sequence BCA (Placebo Control Dentifrice + Reference Dentifrice + Test Dentifrice)
Participants brushed the buccal surfaces of their natural teeth using 1.5+/-0.1 g of Placebo Control Dentifrice containing 0 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 1 (Treatment B) followed by 1.5+/-0.1 g of the Reference Dentifrice containing 1100 ppm fluoride as SnF2 once on Day 1 of Treatment Period 2 (Treatment C) and further followed by 1.5+/-0.1 g of Test Dentifrice containing 1150 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 3 (Treatment A). Participants used the assigned dentifrice under supervision of the study staff while the intraoral appliance was in place and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. There was a washout period of a minimum of 3 days prior to each treatment.
|
Sequence CAB (Reference Dentifrice + Test Dentifrice + Placebo Control Dentifrice)
Participants brushed the buccal surfaces of their natural teeth using 1.5+/-0.1 g of Reference Dentifrice containing 1100 ppm fluoride as SnF2 once on Day 1 of Treatment Period 1 (Treatment C) followed by 1.5+/-0.1 g of the Test Dentifrice containing 1150 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 2 (Treatment A) and further followed by 1.5+/-0.1 g of Placebo Control Dentifrice containing 0 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 3 (Treatment B). Participants used the assigned dentifrice under supervision of the study staff while the intraoral appliance was in place and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. There was a washout period of a minimum of 3 days prior to each treatment.
|
Sequence CBA (Reference Dentifrice + Placebo Control Dentifrice + Test Dentifrice)
Participants brushed the buccal surfaces of their natural teeth using 1.5+/-0.1 g of Reference Dentifrice containing 1100 ppm fluoride as SnF2 once on Day 1 of Treatment Period 1 (Treatment C) followed by 1.5+/-0.1 g of the Placebo Control Dentifrice containing 0 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 2 (Treatment B) and further followed by 1.5+/-0.1 g of Test Dentifrice containing 1150 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 3 (Treatment A). Participants used the assigned dentifrice under supervision of the study staff while the intraoral appliance was in place and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. There was a washout period of a minimum of 3 days prior to each treatment.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1 (2 Days)
STARTED
|
5
|
5
|
6
|
6
|
5
|
6
|
|
Treatment Period 1 (2 Days)
COMPLETED
|
5
|
5
|
6
|
6
|
5
|
6
|
|
Treatment Period 1 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period (3 Days)
STARTED
|
5
|
5
|
6
|
6
|
5
|
6
|
|
Washout Period (3 Days)
COMPLETED
|
5
|
5
|
6
|
6
|
5
|
6
|
|
Washout Period (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (2 Days)
STARTED
|
5
|
5
|
6
|
6
|
5
|
6
|
|
Treatment Period 2 (2 Days)
COMPLETED
|
5
|
5
|
6
|
6
|
5
|
6
|
|
Treatment Period 2 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3 (2 Days)
STARTED
|
5
|
5
|
6
|
6
|
5
|
6
|
|
Treatment Period 3 (2 Days)
COMPLETED
|
5
|
5
|
6
|
6
|
5
|
6
|
|
Treatment Period 3 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Erosion Study to Investigate the Efficacy of an Experimental Dentifrice to Remineralize Enamel
Baseline characteristics by cohort
| Measure |
Overall Study Participants
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/-0.1 g of the Test Dentifrice (Treatment A) containing 1150 ppm fluoride and 5% KNO3, Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3, Reference Dentifrice (Treatment C) containing 1100 ppm fluoride as SnF2 on Day 1 of Treatment Period 1, 2 or 3 as per randomization schedule. Participants used the assigned dentifrice under supervision of the study staff while the intraoral appliance was in place and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds.
|
|---|---|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)Population: ITT population included all participants who were randomized.
%SMHR was used to measure the ability of the dentifrice to remineralize enamel. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and the extent of remineralization was evaluated using surface microhardness (SMH) technique to yield the %SMHR. The enamel specimens were evaluated both prior to and after intra-oral exposure and indentation lengths were measured. The %SMHR was derived as \[(E1-R)/(E1-B)\] \* 100 where: B = indentation length (micrometre \[μm\]) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 hours in situ remineralization.
Outcome measures
| Measure |
Test Dentifrice (Treatment A)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Test Dentifrice (Treatment A) containing 1150 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
|---|---|---|---|
|
Adjusted Mean Percent Surface Microhardness Recovery (%SMHR) at 4 Hours (Test Dentifrice Versus (vs.) Placebo Control Dentifrice)
|
32.20 percent SMHR
Standard Error 2.021
|
23.85 percent SMHR
Standard Error 2.021
|
—
|
SECONDARY outcome
Timeframe: At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)Population: ITT population.
%RER was used to measure the ability of the dentifrice to protect enamel from further acid-induced demineralization by both acid protection and remineralization. SMH technique was used to calculate %RER. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to calculate %RER. The %RER was derived as \[(E1-E2)/(E1-B)\] \* 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice).
Outcome measures
| Measure |
Test Dentifrice (Treatment A)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Test Dentifrice (Treatment A) containing 1150 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
|---|---|---|---|
|
Adjusted Mean Percent Relative Erosion Resistance (%RER) at 4 Hours (Test Dentifrice vs. Placebo Control Dentifrice)
|
-11.56 percent RER
Standard Error 3.024
|
-48.89 percent RER
Standard Error 3.024
|
—
|
SECONDARY outcome
Timeframe: At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)Population: ITT population.
%SMHR was used to measure the ability of the dentifrice to remineralize enamel. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and the extent of remineralization was evaluated using surface SMH technique to yield the %SMHR. The enamel specimens were evaluated both prior to and after intra-oral exposure and indentation lengths were measured. The %SMHR was derived as \[(E1-R)/(E1-B)\] \* 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 hours in situ remineralization.
Outcome measures
| Measure |
Test Dentifrice (Treatment A)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Test Dentifrice (Treatment A) containing 1150 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
|---|---|---|---|
|
Adjusted Mean %SMHR at 4 Hours (Test Dentifrice vs. Reference Dentifrice)
|
32.20 percent SMHR
Standard Error 2.021
|
28.25 percent SMHR
Standard Error 2.019
|
—
|
SECONDARY outcome
Timeframe: At 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)Population: ITT population.
%SMHR was used to measure the ability of the dentifrice to remineralize enamel. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and the extent of remineralization was evaluated using SMH technique to yield the %SMHR. The enamel specimens were evaluated both prior to and after intra-oral exposure and indentation lengths were measured. The %SMHR was derived as \[(E1-R)/(E1-B)\] \* 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 12 hours in situ remineralization.
Outcome measures
| Measure |
Test Dentifrice (Treatment A)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Test Dentifrice (Treatment A) containing 1150 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
|---|---|---|---|
|
Adjusted Mean %SMHR at 12 Hours
|
39.32 percent SMHR
Standard Error 1.826
|
36.66 percent SMHR
Standard Error 1.824
|
33.66 percent SMHR
Standard Error 1.826
|
SECONDARY outcome
Timeframe: At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)Population: ITT population.
%RER was used to measure the ability of the dentifrice to protect enamel from further acid-induced demineralization by both acid protection and remineralization. SMH technique was used to calculate %RER. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to calculate %RER. The %RER was derived as \[(E1-E2)/(E1-B)\] \* 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice).
Outcome measures
| Measure |
Test Dentifrice (Treatment A)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Test Dentifrice (Treatment A) containing 1150 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
|---|---|---|---|
|
Adjusted Mean %RER at 4 Hours (Test Dentifrice vs. Reference Dentifrice)
|
-11.56 percent RER
Standard Error 3.024
|
-13.78 percent RER
Standard Error 3.022
|
—
|
SECONDARY outcome
Timeframe: At 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)Population: ITT population.
%RER was used to measure the ability of the dentifrice to protect enamel from further acid-induced demineralization by both acid protection and remineralization. SMH technique was used to calculate %RER. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to calculate %RER. The %RER was derived as \[(E1-E2)/(E1-B)\] \* 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice).
Outcome measures
| Measure |
Test Dentifrice (Treatment A)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Test Dentifrice (Treatment A) containing 1150 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
|---|---|---|---|
|
Adjusted Mean %RER at 12 Hours
|
-0.28 percent RER
Standard Error 2.760
|
0.19 percent RER
Standard Error 2.759
|
-26.98 percent RER
Standard Error 2.760
|
SECONDARY outcome
Timeframe: At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)Population: ITT population.
EFU is a measure of how much fluoride has been incorporated into the enamel during the process of remineralization. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and chemically analyzed to measure the amount of fluoride incorporated into the enamel by the dentifrice treatment.
Outcome measures
| Measure |
Test Dentifrice (Treatment A)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Test Dentifrice (Treatment A) containing 1150 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
|---|---|---|---|
|
Adjusted Mean Enamel Fluoride Uptake (EFU) at 4 and 12 Hours
At 4 hours of intra-oral exposure
|
4.80 microgram fluoride per square centimeter
Interval 4.31 to 5.35
|
3.81 microgram fluoride per square centimeter
Interval 3.42 to 4.25
|
2.20 microgram fluoride per square centimeter
Interval 1.98 to 2.45
|
|
Adjusted Mean Enamel Fluoride Uptake (EFU) at 4 and 12 Hours
At 12 hours of intra-oral exposure
|
4.80 microgram fluoride per square centimeter
Interval 4.41 to 5.22
|
3.89 microgram fluoride per square centimeter
Interval 3.58 to 4.24
|
2.45 microgram fluoride per square centimeter
Interval 2.25 to 2.66
|
SECONDARY outcome
Timeframe: At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)Population: ITT population.
ARR was used to measure the resistance of the remineralized enamel to further acid softening. SMH technique was used to calculate ARR. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to calculate ARR. The ARR was derived as 1 - \[(E2-R)/(E1-B)\] where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 and 12 hours in situ remineralization.
Outcome measures
| Measure |
Test Dentifrice (Treatment A)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Test Dentifrice (Treatment A) containing 1150 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
|---|---|---|---|
|
Adjusted Mean Acid Resistance Ratio (ARR) at 4 and 12 Hours
At 4 hours of intra-oral exposure
|
0.562 ratio
Standard Error 0.0214
|
0.580 ratio
Standard Error 0.0214
|
0.273 ratio
Standard Error 0.0214
|
|
Adjusted Mean Acid Resistance Ratio (ARR) at 4 and 12 Hours
At 12 hours of intra-oral exposure
|
0.604 ratio
Standard Error 0.0200
|
0.635 ratio
Standard Error 0.0200
|
0.394 ratio
Standard Error 0.0200
|
SECONDARY outcome
Timeframe: At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)Population: ITT population.
%SMHR was used to measure the ability of the dentifrice to remineralize enamel. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatment in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and the extent of remineralization was evaluated using SMH technique to yield the %SMHR. The enamel specimens were evaluated both prior to and after intra-oral exposure and indentation lengths were measured. The %SMHR was derived as \[(E1-R)/(E1-B)\] \* 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 and 12 hours in situ remineralization.
Outcome measures
| Measure |
Test Dentifrice (Treatment A)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Test Dentifrice (Treatment A) containing 1150 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
|---|---|---|---|
|
Adjusted Mean %SMHR at 4 and 12 Hours (Reference Dentifrice vs Placebo Control Dentifrice)
At 4 hours of intra-oral exposure
|
28.25 percent SMHR
Standard Error 2.019
|
23.85 percent SMHR
Standard Error 2.021
|
—
|
|
Adjusted Mean %SMHR at 4 and 12 Hours (Reference Dentifrice vs Placebo Control Dentifrice)
At 12 hours of intra-oral exposure
|
36.66 percent SMHR
Standard Error 1.824
|
33.66 percent SMHR
Standard Error 1.826
|
—
|
SECONDARY outcome
Timeframe: At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)Population: ITT population.
%RER was used to measure the ability of the dentifrice to protect enamel from further acid-induced demineralization by both acid protection and remineralization. SMH technique was used to calculate %RER. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to calculate %RER. The %RER was derived as \[(E1-E2)/(E1-B)\] \* 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice).
Outcome measures
| Measure |
Test Dentifrice (Treatment A)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Test Dentifrice (Treatment A) containing 1150 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
|---|---|---|---|
|
Adjusted Mean %RER at 4 and 12 Hours (Reference Dentifrice vs Placebo Control Dentifrice)
At 4 hours of intra-oral exposure
|
-13.78 percent RER
Standard Error 3.022
|
-48.89 percent RER
Standard Error 3.024
|
—
|
|
Adjusted Mean %RER at 4 and 12 Hours (Reference Dentifrice vs Placebo Control Dentifrice)
At 12 hours of intra-oral exposure
|
0.19 percent RER
Standard Error 2.759
|
-26.98 percent RER
Standard Error 2.760
|
—
|
SECONDARY outcome
Timeframe: At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)Population: ITT population.
EFU is a measure of how much fluoride has been incorporated into the enamel during the process of remineralization. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and chemically analyzed to measure the amount of fluoride incorporated into the enamel by the dentifrice treatment.
Outcome measures
| Measure |
Test Dentifrice (Treatment A)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Test Dentifrice (Treatment A) containing 1150 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
|---|---|---|---|
|
Adjusted Mean EFU at 4 and 12 Hours (Reference Dentifrice vs Placebo Control Dentifrice)
At 4 hours of intra-oral exposure
|
3.81 microgram fluoride per square centimeter
Interval 3.42 to 4.25
|
2.20 microgram fluoride per square centimeter
Interval 1.98 to 2.45
|
—
|
|
Adjusted Mean EFU at 4 and 12 Hours (Reference Dentifrice vs Placebo Control Dentifrice)
At 12 hours of intra-oral exposure
|
3.89 microgram fluoride per square centimeter
Interval 3.58 to 4.24
|
2.45 microgram fluoride per square centimeter
Interval 2.25 to 2.66
|
—
|
SECONDARY outcome
Timeframe: At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between)Population: ITT population.
ARR was used to measure the resistance of the remineralized enamel to further acid softening. SMH technique was used to calculate ARR. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to yield ARR. The ARR was derived as 1 - \[(E2-R)/(E1-B)\] where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 and 12 hours in situ remineralization.
Outcome measures
| Measure |
Test Dentifrice (Treatment A)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Test Dentifrice (Treatment A) containing 1150 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
n=33 Participants
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
|---|---|---|---|
|
Adjusted Mean ARR at 4 and 12 Hours (Reference Dentifrice vs Placebo Control Dentifrice)
At 4 hours of intra-oral exposure
|
0.580 ratio
Standard Error 0.0214
|
0.273 ratio
Standard Error 0.0214
|
—
|
|
Adjusted Mean ARR at 4 and 12 Hours (Reference Dentifrice vs Placebo Control Dentifrice)
At 12 hours of intra-oral exposure
|
0.635 ratio
Standard Error 0.0200
|
0.394 ratio
Standard Error 0.0200
|
—
|
Adverse Events
Test Dentifrice (Treatment A)
Reference Dentifrice (Treatment C)
Placebo Control Dentifrice (Treatment B)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Dentifrice (Treatment A)
n=33 participants at risk
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Test Dentifrice (Treatment A) containing 1150 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Reference Dentifrice (Treatment C)
n=33 participants at risk
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Reference Dentifrice (Treatment C) containing 1100 ppm fluoride as SnF2 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
Placebo Control Dentifrice (Treatment B)
n=33 participants at risk
Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place.
|
|---|---|---|---|
|
Gastrointestinal disorders
Pulpitis irreversible
|
0.00%
0/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
0.00%
0/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
3.0%
1/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
0.00%
0/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
12.1%
4/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
|
Psychiatric disorders
Anxiety worsening
|
3.0%
1/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
0.00%
0/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
0.00%
0/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
|
Nervous system disorders
Bell's palsy
|
3.0%
1/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
0.00%
0/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
0.00%
0/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
|
Musculoskeletal and connective tissue disorders
Back Pain, Worsening
|
3.0%
1/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
0.00%
0/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
0.00%
0/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
3.0%
1/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
0.00%
0/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
|
Musculoskeletal and connective tissue disorders
Trigger Finger
|
3.0%
1/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
0.00%
0/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
0.00%
0/33 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER