Trial Outcomes & Findings for Study to Evaluate the Effectiveness of Test Dentifrice in the Relief of Dentinal Hypersensitivity (NCT NCT07317128)
NCT ID: NCT07317128
Last Updated: 2026-05-13
Results Overview
Evaporative (air) sensitivity was evaluated using the Schiff Sensitivity Score on test teeth for each participant. After the examiner applied a standardized air stimulus, the participant's response was rated on a 0 to 3 scale, where 0 equal to (=) no response to the stimulus, 1= response to air stimulus without request for discontinuation of the stimulus, 2= response to air stimulus with request for discontinuation of the stimulus, and 3= a painful response with a request for discontinuation of the stimulus. Lower score indicated improvement. Change from Baseline was calculated by subtracting the Baseline score from the score at indicated timepoint.
COMPLETED
NA
120 participants
Baseline and Week 12
2026-05-13
Participant Flow
This study was conducted at a single center in China.
A total of 120 participants were enrolled and randomized into three treatment groups: 42 participants to the Test Dentifrice group, 40 participants to the Comparator group and 38 participants to the Negative Control group. All 120 participants completed the study.
Participant milestones
| Measure |
Test Dentifrice
Participants were instructed to apply a full ribbon of test dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
Comparator Dentifrice
Participants were instructed to apply a full ribbon of the comparator dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
Negative Control Dentifrice
Participants were instructed to apply a full ribbon of the negative control dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
40
|
38
|
|
Overall Study
COMPLETED
|
42
|
40
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Effectiveness of Test Dentifrice in the Relief of Dentinal Hypersensitivity
Baseline characteristics by cohort
| Measure |
Test Dentifrice
n=42 Participants
Participants were instructed to apply a full ribbon of test dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
Comparator Dentifrice
n=40 Participants
Participants were instructed to apply a full ribbon of the comparator dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
Negative Control Dentifrice
n=38 Participants
Participants were instructed to apply a full ribbon of the negative control dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.4 years
STANDARD_DEVIATION 9.06 • n=1512 Participants
|
40.8 years
STANDARD_DEVIATION 6.49 • n=504 Participants
|
39.1 years
STANDARD_DEVIATION 6.95 • n=2016 Participants
|
40.1 years
STANDARD_DEVIATION 7.59 • n=99 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=1512 Participants
|
36 Participants
n=504 Participants
|
31 Participants
n=2016 Participants
|
104 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=1512 Participants
|
4 Participants
n=504 Participants
|
7 Participants
n=2016 Participants
|
16 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=1512 Participants
|
40 Participants
n=504 Participants
|
38 Participants
n=2016 Participants
|
120 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
42 Participants
n=1512 Participants
|
40 Participants
n=504 Participants
|
38 Participants
n=2016 Participants
|
120 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The intent-to-treat (ITT) population included all participants who were randomised, administered the study treatment at least once during the study and provided at least one post-baseline assessment of efficacy.
Evaporative (air) sensitivity was evaluated using the Schiff Sensitivity Score on test teeth for each participant. After the examiner applied a standardized air stimulus, the participant's response was rated on a 0 to 3 scale, where 0 equal to (=) no response to the stimulus, 1= response to air stimulus without request for discontinuation of the stimulus, 2= response to air stimulus with request for discontinuation of the stimulus, and 3= a painful response with a request for discontinuation of the stimulus. Lower score indicated improvement. Change from Baseline was calculated by subtracting the Baseline score from the score at indicated timepoint.
Outcome measures
| Measure |
Negative Control Dentifrice
n=38 Participants
Participants were instructed to apply a full ribbon of the negative control dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
Test Dentifrice
n=42 Participants
Participants were instructed to apply a full ribbon of test dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Week 12 (Test Dentifrice Versus [vs] Negative Control Dentifrice)
|
-0.44 score on a scale
Standard Error 0.084
|
-1.19 score on a scale
Standard Error 0.108
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, and 8Population: ITT population. Only those participants with data available at the indicated timepoint were analyzed.
Evaporative (air) sensitivity was evaluated using the Schiff Sensitivity Score on test teeth for each participant. After the examiner applied a standardized air stimulus, the participant's response was rated on a 0 to 3 scale, where 0= no response to the stimulus, 1= response to air stimulus without request for discontinuation of the stimulus, 2= response to air stimulus with request for discontinuation of the stimulus, and 3= a painful response with a request for discontinuation of the stimulus. Lower score indicated improvement. Change from Baseline was calculated by subtracting the Baseline score from the score at indicated timepoints.
Outcome measures
| Measure |
Negative Control Dentifrice
n=38 Participants
Participants were instructed to apply a full ribbon of the negative control dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
Test Dentifrice
n=42 Participants
Participants were instructed to apply a full ribbon of test dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4 and 8 (Test Dentifrice vs Negative Control Dentifrice)
Week 2
|
-0.06 score on a scale
Standard Error 0.057
|
-0.44 score on a scale
Standard Error 0.066
|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4 and 8 (Test Dentifrice vs Negative Control Dentifrice)
Week 4
|
-0.20 score on a scale
Standard Error 0.061
|
-0.67 score on a scale
Standard Error 0.081
|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4 and 8 (Test Dentifrice vs Negative Control Dentifrice)
Week 8
|
-0.47 score on a scale
Standard Error 0.072
|
-0.92 score on a scale
Standard Error 0.096
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: ITT population. Only those participants with data available at the indicated timepoint were analyzed.
Evaporative (air) sensitivity was assessed on the test teeth by applying a 1-second air stimulus from a standard dental syringe. Participants rated the intensity of their response to the evaporative (air) stimulus using a 100 millimeter (mm) VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable). Higher score indicated worse outcome (higher sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoints.
Outcome measures
| Measure |
Negative Control Dentifrice
n=38 Participants
Participants were instructed to apply a full ribbon of the negative control dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
Test Dentifrice
n=42 Participants
Participants were instructed to apply a full ribbon of test dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Visual Analogue Scale (VAS) at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Negative Control Dentifrice)
Week 2
|
-6.74 score on a scale
Standard Error 2.833
|
-7.69 score on a scale
Standard Error 2.149
|
|
Adjusted Mean Change From Baseline in Visual Analogue Scale (VAS) at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Negative Control Dentifrice)
Week 4
|
-12.59 score on a scale
Standard Error 2.748
|
-12.99 score on a scale
Standard Error 3.084
|
|
Adjusted Mean Change From Baseline in Visual Analogue Scale (VAS) at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Negative Control Dentifrice)
Week 8
|
-16.81 score on a scale
Standard Error 3.374
|
-21.80 score on a scale
Standard Error 3.236
|
|
Adjusted Mean Change From Baseline in Visual Analogue Scale (VAS) at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Negative Control Dentifrice)
Week 12
|
-19.47 score on a scale
Standard Error 3.917
|
-29.21 score on a scale
Standard Error 4.028
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: ITT population. Only those participants with data available at the indicated timepoint were analyzed.
Tactile sensitivity was assessed for eligible teeth using a constant pressure probe (Yeaple probe). After each application of the stimulus, participants were asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (grams \[g\]). Higher tactile threshold indicated a better outcome (less sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoints.
Outcome measures
| Measure |
Negative Control Dentifrice
n=38 Participants
Participants were instructed to apply a full ribbon of the negative control dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
Test Dentifrice
n=42 Participants
Participants were instructed to apply a full ribbon of test dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Negative Control Dentifrice)
Week 2
|
3.48 g
Standard Error 1.065
|
8.69 g
Standard Error 1.815
|
|
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Negative Control Dentifrice)
Week 4
|
5.02 g
Standard Error 1.843
|
13.92 g
Standard Error 2.894
|
|
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Negative Control Dentifrice)
Week 8
|
5.46 g
Standard Error 1.709
|
19.67 g
Standard Error 2.744
|
|
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Negative Control Dentifrice)
Week 12
|
7.76 g
Standard Error 1.948
|
31.64 g
Standard Error 3.870
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: ITT population. Only those participants with data available at the indicated timepoint were analyzed.
Evaporative (air) sensitivity was evaluated using the Schiff Sensitivity Score on test teeth for each participant. After the examiner applied a standardized air stimulus, the participant's response was rated on a 0 to 3 scale, where 0= no response to the stimulus, 1= response to air stimulus without request for discontinuation of the stimulus, 2= response to air stimulus with request for discontinuation of the stimulus, and 3= a painful response with a request for discontinuation of the stimulus. Lower score indicated improvement. Change from Baseline was calculated by subtracting the Baseline score from the score at indicated timepoints.
Outcome measures
| Measure |
Negative Control Dentifrice
n=38 Participants
Participants were instructed to apply a full ribbon of the negative control dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
Test Dentifrice
n=40 Participants
Participants were instructed to apply a full ribbon of test dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
Week 2
|
-0.06 score on a scale
Standard Error 0.057
|
-0.69 score on a scale
Standard Error 0.079
|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
Week 4
|
-0.20 score on a scale
Standard Error 0.061
|
-0.80 score on a scale
Standard Error 0.084
|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
Week 8
|
-0.47 score on a scale
Standard Error 0.072
|
-1.10 score on a scale
Standard Error 0.097
|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
Week 12
|
-0.44 score on a scale
Standard Error 0.084
|
-1.44 score on a scale
Standard Error 0.093
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: ITT population. Only those participants with data available at the indicated timepoint were analyzed.
Evaporative (air) sensitivity was assessed on the test teeth by applying a 1-second air stimulus from a standard dental syringe. Participants rated the intensity of their response to the evaporative (air) stimulus using a 100 mm VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable). Higher score indicated worse outcome (higher sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoints.
Outcome measures
| Measure |
Negative Control Dentifrice
n=38 Participants
Participants were instructed to apply a full ribbon of the negative control dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
Test Dentifrice
n=40 Participants
Participants were instructed to apply a full ribbon of test dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in VAS at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
Week 2
|
-6.74 score on a scale
Standard Error 2.833
|
-9.28 score on a scale
Standard Error 3.053
|
|
Adjusted Mean Change From Baseline in VAS at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
Week 4
|
-12.59 score on a scale
Standard Error 2.748
|
-14.40 score on a scale
Standard Error 2.844
|
|
Adjusted Mean Change From Baseline in VAS at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
Week 8
|
-16.81 score on a scale
Standard Error 3.374
|
-20.94 score on a scale
Standard Error 3.687
|
|
Adjusted Mean Change From Baseline in VAS at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
Week 12
|
-19.47 score on a scale
Standard Error 3.917
|
-28.79 score on a scale
Standard Error 3.617
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: ITT population. Only those participants with data available at the indicated timepoint were analyzed.
Tactile sensitivity was assessed for eligible teeth using a constant pressure probe (Yeaple probe). After each application of the stimulus, participants were asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (g). Higher tactile threshold indicated better outcome (less sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoints.
Outcome measures
| Measure |
Negative Control Dentifrice
n=38 Participants
Participants were instructed to apply a full ribbon of the negative control dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
Test Dentifrice
n=40 Participants
Participants were instructed to apply a full ribbon of test dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
Week 2
|
3.48 g
Standard Error 1.065
|
9.54 g
Standard Error 1.725
|
|
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
Week 4
|
5.02 g
Standard Error 1.843
|
14.37 g
Standard Error 2.226
|
|
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
Week 8
|
5.46 g
Standard Error 1.709
|
17.05 g
Standard Error 2.505
|
|
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Comparator Dentifrice vs Negative Control Dentifrice)
Week 12
|
7.76 g
Standard Error 1.948
|
28.54 g
Standard Error 3.573
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: ITT population. Only those participants with data available at the indicated timepoint were analyzed.
Evaporative (air) sensitivity was evaluated using the Schiff Sensitivity Score on test teeth for each participant. After the examiner applied a standardized air stimulus, the participant's response was rated on a 0 to 3 scale, where 0= no response to the stimulus, 1= response to air stimulus without request for discontinuation of the stimulus, 2= response to air stimulus with request for discontinuation of the stimulus, and 3= a painful response with a request for discontinuation of the stimulus. Lower score indicated improvement. Change from Baseline was calculated by subtracting the Baseline score from the score at indicated timepoints.
Outcome measures
| Measure |
Negative Control Dentifrice
n=40 Participants
Participants were instructed to apply a full ribbon of the negative control dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
Test Dentifrice
n=42 Participants
Participants were instructed to apply a full ribbon of test dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
Week 2
|
-0.69 score on a scale
Standard Error 0.079
|
-0.44 score on a scale
Standard Error 0.066
|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
Week 4
|
-0.80 score on a scale
Standard Error 0.084
|
-0.67 score on a scale
Standard Error 0.081
|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
Week 8
|
-1.10 score on a scale
Standard Error 0.097
|
-0.92 score on a scale
Standard Error 0.096
|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
Week 12
|
-1.44 score on a scale
Standard Error 0.093
|
-1.19 score on a scale
Standard Error 0.108
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: ITT population. Only those participants with data available at the indicated timepoint were analyzed.
Evaporative (air) sensitivity was assessed on the test teeth by applying a 1-second air stimulus from a standard dental syringe. Participants rated the intensity of their response to the evaporative (air) stimulus using a 100 mm VAS with scores ranging from 0 mm (No discomfort) to 100 mm (Extreme discomfort; worst imaginable). Higher score indicated worse outcome (higher sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoints.
Outcome measures
| Measure |
Negative Control Dentifrice
n=40 Participants
Participants were instructed to apply a full ribbon of the negative control dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
Test Dentifrice
n=42 Participants
Participants were instructed to apply a full ribbon of test dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in VAS at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
Week 2
|
-9.28 score on a scale
Standard Error 3.053
|
-7.69 score on a scale
Standard Error 2.149
|
|
Adjusted Mean Change From Baseline in VAS at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
Week 4
|
-14.40 score on a scale
Standard Error 2.844
|
-12.99 score on a scale
Standard Error 3.084
|
|
Adjusted Mean Change From Baseline in VAS at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
Week 8
|
-20.94 score on a scale
Standard Error 3.687
|
-21.80 score on a scale
Standard Error 3.236
|
|
Adjusted Mean Change From Baseline in VAS at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
Week 12
|
-28.79 score on a scale
Standard Error 3.617
|
-29.21 score on a scale
Standard Error 4.028
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: ITT population. Only those participants with data available at the indicated timepoint were analyzed.
Tactile sensitivity was assessed for eligible teeth using a constant pressure probe (Yeaple probe). After each application of the stimulus, participants were asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold (g). Higher tactile threshold indicated better outcome (less sensitivity). Change from Baseline was calculated by subtracting Baseline value from the value at indicated timepoints.
Outcome measures
| Measure |
Negative Control Dentifrice
n=40 Participants
Participants were instructed to apply a full ribbon of the negative control dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
Test Dentifrice
n=42 Participants
Participants were instructed to apply a full ribbon of test dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
Week 2
|
9.54 g
Standard Error 1.725
|
8.69 g
Standard Error 1.815
|
|
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
Week 4
|
14.37 g
Standard Error 2.226
|
13.92 g
Standard Error 2.894
|
|
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
Week 8
|
17.05 g
Standard Error 2.505
|
19.67 g
Standard Error 2.744
|
|
Adjusted Mean Change From Baseline in Tactile Threshold at Weeks 2, 4, 8 and 12 (Test Dentifrice vs Comparator Dentifrice)
Week 12
|
28.54 g
Standard Error 3.573
|
31.64 g
Standard Error 3.870
|
Adverse Events
Test Dentifrice
Comparator Dentifrice
Negative Control Dentifrice
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Dentifrice
n=42 participants at risk
Participants were instructed to apply a full ribbon of test dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
Comparator Dentifrice
n=40 participants at risk
Participants were instructed to apply a full ribbon of the comparator dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
Negative Control Dentifrice
n=38 participants at risk
Participants were instructed to apply a full ribbon of the negative control dentifrice to cover the head of the assigned toothbrush and brush twice daily for 1 timed minute throughout the 12-week treatment period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Mouth Ulceration
|
2.4%
1/42 • Immediately from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product (Approximately up to 117 days).
|
0.00%
0/40 • Immediately from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product (Approximately up to 117 days).
|
0.00%
0/38 • Immediately from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product (Approximately up to 117 days).
|
|
Infections and infestations
Pharyngitis
|
2.4%
1/42 • Immediately from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product (Approximately up to 117 days).
|
0.00%
0/40 • Immediately from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product (Approximately up to 117 days).
|
0.00%
0/38 • Immediately from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product (Approximately up to 117 days).
|
|
Vascular disorders
Hypertension
|
0.00%
0/42 • Immediately from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product (Approximately up to 117 days).
|
2.5%
1/40 • Immediately from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product (Approximately up to 117 days).
|
0.00%
0/38 • Immediately from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product (Approximately up to 117 days).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/42 • Immediately from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product (Approximately up to 117 days).
|
2.5%
1/40 • Immediately from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product (Approximately up to 117 days).
|
0.00%
0/38 • Immediately from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product (Approximately up to 117 days).
|
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