Trial Outcomes & Findings for Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity (NCT NCT04590040)
NCT ID: NCT04590040
Last Updated: 2023-08-16
Results Overview
The primary efficacy outcome will be the decrease in cold air stimulus sensitivity (VAS score) from baseline to 8 weeks. Assessment of change in cold air sensitivity will be conducted using air delivered from a standard dental unit air syringe at room temperature (\~70°F±3°F)(\~21°C±2°C) and a pressure of 60psi (± 5psi). Assessment of sensitivity will be carried out using Visual Analog Scale (VAS). Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort.
COMPLETED
NA
192 participants
Week 0 (baseline), 4 weeks and 8 weeks
2023-08-16
Participant Flow
Subjects were consented and enrolled, then for one month there was a washout period. Baseline characteristic measurements were taken prior to washout for both Cold Air Sensitivity and Tactile Stimulus.
Participant milestones
| Measure |
Toothpaste 1
Toothpaste 1 containing 0% nano-hydroxyapatite (HAP) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush.
Placebo: 0% nano-HAP toothpaste
|
Toothpaste 2
Toothpaste 2 containing 15% nano-HAP will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush.
15% nano-HAP toothpaste: Toothpaste with identical base formulation as the placebo containing 15% nano-HAP
|
Toothpaste 3
Toothpaste 3 containing 5% potassium nitrate (KNO3) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush.
5% KNO3 toothpaste: Toothpaste with identical base formulation as the placebo containing 5% KNO3
|
|---|---|---|---|
|
Washout Period
STARTED
|
64
|
64
|
64
|
|
Washout Period
COMPLETED
|
64
|
64
|
64
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Treatment Period
STARTED
|
64
|
64
|
64
|
|
Treatment Period
COMPLETED
|
62
|
59
|
62
|
|
Treatment Period
NOT COMPLETED
|
2
|
5
|
2
|
Reasons for withdrawal
| Measure |
Toothpaste 1
Toothpaste 1 containing 0% nano-hydroxyapatite (HAP) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush.
Placebo: 0% nano-HAP toothpaste
|
Toothpaste 2
Toothpaste 2 containing 15% nano-HAP will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush.
15% nano-HAP toothpaste: Toothpaste with identical base formulation as the placebo containing 15% nano-HAP
|
Toothpaste 3
Toothpaste 3 containing 5% potassium nitrate (KNO3) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush.
5% KNO3 toothpaste: Toothpaste with identical base formulation as the placebo containing 5% KNO3
|
|---|---|---|---|
|
Treatment Period
Lost to Follow-up
|
2
|
5
|
0
|
|
Treatment Period
Physician Decision
|
0
|
0
|
2
|
Baseline Characteristics
Trial of Nano-hydroxyapatite-Containing Toothpastes for Relief of Dentin Hypersensitivity
Baseline characteristics by cohort
| Measure |
Toothpaste 1
n=62 Participants
Toothpaste 1 containing 0% nano-hydroxyapatite (HAP) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush.
Placebo: 0% nano-HAP toothpaste
|
Toothpaste 2
n=59 Participants
Toothpaste 2 containing 15% nano-HAP will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush.
15% nano-HAP toothpaste: Toothpaste with identical base formulation as the placebo containing 15% nano-HAP
|
Toothpaste 3
n=62 Participants
Toothpaste 3 containing 5% potassium nitrate (KNO3) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush.
5% KNO3 toothpaste: Toothpaste with identical base formulation as the placebo containing 5% KNO3
|
Total
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 16 • n=5 Participants
|
47 years
STANDARD_DEVIATION 16 • n=7 Participants
|
50 years
STANDARD_DEVIATION 14 • n=5 Participants
|
48 years
STANDARD_DEVIATION 15 • n=4 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
15 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black (not Hispanic)
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White (not Hispanic)
|
14 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=5 Participants
|
59 participants
n=7 Participants
|
62 participants
n=5 Participants
|
183 participants
n=4 Participants
|
|
Cold Air Sensitivity (VAS)
|
69 units on a scale
STANDARD_DEVIATION 20 • n=5 Participants
|
67 units on a scale
STANDARD_DEVIATION 16 • n=7 Participants
|
65 units on a scale
STANDARD_DEVIATION 18 • n=5 Participants
|
67 units on a scale
STANDARD_DEVIATION 18 • n=4 Participants
|
|
Tactile (g)
|
15 grams
STANDARD_DEVIATION 7 • n=5 Participants
|
15 grams
STANDARD_DEVIATION 7 • n=7 Participants
|
16 grams
STANDARD_DEVIATION 7 • n=5 Participants
|
15.3 grams
STANDARD_DEVIATION 7 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week 0 (baseline), 4 weeks and 8 weeksThe primary efficacy outcome will be the decrease in cold air stimulus sensitivity (VAS score) from baseline to 8 weeks. Assessment of change in cold air sensitivity will be conducted using air delivered from a standard dental unit air syringe at room temperature (\~70°F±3°F)(\~21°C±2°C) and a pressure of 60psi (± 5psi). Assessment of sensitivity will be carried out using Visual Analog Scale (VAS). Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort.
Outcome measures
| Measure |
Toothpaste 1
n=62 Participants
Toothpaste 3 containing 5% potassium nitrate (KNO3) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush.
5% KNO3 toothpaste: Toothpaste with identical base formulation as the placebo containing 5% KNO3
|
Toothpaste 2
n=59 Participants
Toothpaste 2 containing 15% nano-HAP will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush.
15% nano-HAP toothpaste: Toothpaste with identical base formulation as the placebo containing 15% nano-HAP
|
Toothpaste 3
n=62 Participants
Toothpaste 1 containing 0% nano-hydroxyapatite (HAP) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush.
Placebo: 0% nano-HAP toothpaste
|
|---|---|---|---|
|
Measurement of Cold Air Stimulus
Week 0 (Baseline)
|
71.4 units on a scale
Standard Deviation 1.4
|
72.2 units on a scale
Standard Deviation 1.47
|
71.9 units on a scale
Standard Deviation 1.61
|
|
Measurement of Cold Air Stimulus
Week 4
|
51.1 units on a scale
Standard Deviation 1.84
|
51.9 units on a scale
Standard Deviation 2.28
|
62 units on a scale
Standard Deviation 2
|
|
Measurement of Cold Air Stimulus
Week 8
|
35.6 units on a scale
Standard Deviation 1.9
|
37.7 units on a scale
Standard Deviation 2.19
|
48.4 units on a scale
Standard Deviation 2.21
|
SECONDARY outcome
Timeframe: Week 0 (baseline), 4 weeks and 8 weeksThe secondary efficacy outcome will be the increase in tactile stimulus force from baseline to 8 weeks. Assessment of Change in tactile sensitivity will be assessed using the Yeaple Electronic Force Sensing Probe.The explorer tip will be applied perpendicular to the tooth surface and a pressure load applied starting at 10 g and increasing to 80g. The load at which the subject says "yes" will be recorded. (Baseline screening will begin at 30g).
Outcome measures
| Measure |
Toothpaste 1
n=62 Participants
Toothpaste 3 containing 5% potassium nitrate (KNO3) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush.
5% KNO3 toothpaste: Toothpaste with identical base formulation as the placebo containing 5% KNO3
|
Toothpaste 2
n=59 Participants
Toothpaste 2 containing 15% nano-HAP will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush.
15% nano-HAP toothpaste: Toothpaste with identical base formulation as the placebo containing 15% nano-HAP
|
Toothpaste 3
n=62 Participants
Toothpaste 1 containing 0% nano-hydroxyapatite (HAP) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush.
Placebo: 0% nano-HAP toothpaste
|
|---|---|---|---|
|
Measurement of Tactile Stimulus
0 weeks (Baseline)
|
13.7 Grams
Standard Deviation 0.48
|
14.1 Grams
Standard Deviation 0.57
|
14.8 Grams
Standard Deviation 0.57
|
|
Measurement of Tactile Stimulus
4 Weeks
|
23.6 Grams
Standard Deviation 1.15
|
23.2 Grams
Standard Deviation 1.37
|
17.7 Grams
Standard Deviation 1.06
|
|
Measurement of Tactile Stimulus
8 weeks
|
31.7 Grams
Standard Deviation 1.58
|
28.7 Grams
Standard Deviation 1.77
|
22.9 Grams
Standard Deviation 1.27
|
Adverse Events
Toothpaste 1
Toothpaste 2
Toothpaste 3
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place