Trial Outcomes & Findings for Clinical Efficacy in Relieving Dentin Hypersensitivity of Nanohydroxyapatite-Containing Toothpastes and Cream (NCT NCT02918617)
NCT ID: NCT02918617
Last Updated: 2018-11-16
Results Overview
Patient's response to an air stimulus is recorded on a Visual Analog Scale of 0-100 with 0 representing no pain and 100 representing the worst possible pain.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
203 participants
Primary outcome timeframe
Baseline to 8 weeks
Results posted on
2018-11-16
Participant Flow
Participant milestones
| Measure |
Control Toothpaste Containing Novamin® Technology
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Control toothpaste containing Novamin® technology
|
Control Toothpaste Containing 1500 Ppm Fluoride as MFP
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Control toothpaste containing 1500 ppm fluoride as MFP
|
Test Toothpaste With Nano-HAP (High Concentration)
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (high concentration)
|
Test Toothpaste With Nano-HAP (Low Concentration)
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (low concentration)
|
Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3)
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP and KNO3
|
Control Toothpaste Without Nano-HAP
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Control toothpaste without nano-HAP
|
Test Toothpaste With Nano-HAP (Medium Concentration)
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (medium concentration)
|
Test Cream With Nano-HAP (Higher Concentration)
Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.
Test cream with nano-HAP (higher concentration)
|
Control Cream Without Nano-HAP
Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.
Control cream without nano-HAP
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
22
|
22
|
24
|
20
|
22
|
26
|
26
|
|
Overall Study
COMPLETED
|
20
|
20
|
19
|
22
|
24
|
20
|
22
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Efficacy in Relieving Dentin Hypersensitivity of Nanohydroxyapatite-Containing Toothpastes and Cream
Baseline characteristics by cohort
| Measure |
Control Toothpaste Containing Novamin® Technology
n=20 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Control toothpaste containing Novamin® technology
|
Control Toothpaste Containing 1500 Ppm Fluoride as MFP
n=20 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Control toothpaste containing 1500 ppm fluoride as MFP
|
Test Toothpaste With Nano-HAP (High Concentration)
n=19 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (high concentration)
|
Test Toothpaste With Nano-HAP (Low Concentration)
n=22 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (low concentration)
|
Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3)
n=24 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP and KNO3
|
Control Toothpaste Without Nano-HAP
n=20 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Control toothpaste without nano-HAP
|
Test Toothpaste With Nano-HAP (Medium Concentration)
n=22 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (medium concentration)
|
Test Cream With Nano-HAP (Higher Concentration)
n=25 Participants
Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.
Test cream with nano-HAP (higher concentration)
|
Control Cream Without Nano-HAP
n=26 Participants
Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.
Control cream without nano-HAP
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.3 Years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
45.85 Years
STANDARD_DEVIATION 15.76 • n=7 Participants
|
53.6 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
52.8 Years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
43.7 Years
STANDARD_DEVIATION 12.8 • n=21 Participants
|
45.35 Years
STANDARD_DEVIATION 11.37 • n=8 Participants
|
47.14 Years
STANDARD_DEVIATION 14.54 • n=8 Participants
|
41.4 Years
STANDARD_DEVIATION 14.14 • n=24 Participants
|
49.38 Years
STANDARD_DEVIATION 10.62 • n=42 Participants
|
47.61 Years
STANDARD_DEVIATION 12.44 • n=42 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
22 Participants
n=42 Participants
|
152 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
46 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race Ethnicity · Asian or Pacific Islander
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race Ethnicity · Black not Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race Ethnicity · Hispanic
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
111 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race Ethnicity · Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race Ethnicity · White not Hispanic
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
48 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksPatient's response to an air stimulus is recorded on a Visual Analog Scale of 0-100 with 0 representing no pain and 100 representing the worst possible pain.
Outcome measures
| Measure |
Test Toothpaste With Nano-HAP (Medium Concentration)
n=22 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (medium concentration)
|
Test Cream With Nano-HAP (Higher Concentration)
n=25 Participants
Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.
Test cream with nano-HAP (higher concentration)
|
Control Cream Without Nano-HAP
n=26 Participants
Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.
Control cream without nano-HAP
|
Control Toothpaste Containing Novamin® Technology
n=20 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Control toothpaste containing Novamin® technology
|
Control Toothpaste Containing 1500 Ppm Fluoride as MFP
n=20 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Control toothpaste containing 1500 ppm fluoride as MFP
|
Test Toothpaste With Nano-HAP (High Concentration)
n=19 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (high concentration)
|
Test Toothpaste With Nano-HAP (Low Concentration)
n=22 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (low concentration)
|
Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3)
n=24 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP and KNO3
|
Control Toothpaste Without Nano-HAP
n=20 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Control toothpaste without nano-HAP
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in VAS (Visual Analog Scale) With Air Stimulation
|
-56.85 percentage change from baseline
Standard Error 7.98
|
-38.99 percentage change from baseline
Standard Error 5.37
|
-50.67 percentage change from baseline
Standard Error 4.93
|
-51.44 percentage change from baseline
Standard Error 5.31
|
-51.59 percentage change from baseline
Standard Error 5.57
|
-41.59 percentage change from baseline
Standard Error 8.08
|
-38.64 percentage change from baseline
Standard Error 5.85
|
-53.16 percentage change from baseline
Standard Error 5.99
|
-47.19 percentage change from baseline
Standard Error 7.13
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksPatient's response to cold stimulus is recorded on a Visual Analog Scale of 0-100 with 0 signifying no pain and 100 signifying the worst possible pain
Outcome measures
| Measure |
Test Toothpaste With Nano-HAP (Medium Concentration)
n=22 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (medium concentration)
|
Test Cream With Nano-HAP (Higher Concentration)
n=25 Participants
Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.
Test cream with nano-HAP (higher concentration)
|
Control Cream Without Nano-HAP
n=26 Participants
Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.
Control cream without nano-HAP
|
Control Toothpaste Containing Novamin® Technology
n=20 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Control toothpaste containing Novamin® technology
|
Control Toothpaste Containing 1500 Ppm Fluoride as MFP
n=20 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Control toothpaste containing 1500 ppm fluoride as MFP
|
Test Toothpaste With Nano-HAP (High Concentration)
n=19 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (high concentration)
|
Test Toothpaste With Nano-HAP (Low Concentration)
n=22 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (low concentration)
|
Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3)
n=24 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP and KNO3
|
Control Toothpaste Without Nano-HAP
n=20 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Control toothpaste without nano-HAP
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in VAS (Visual Analog Scale) With Cold Stimulation
|
-48.80 percentage change from baseline
Standard Error 6.21
|
-34.90 percentage change from baseline
Standard Error 3.4
|
-39.36 percentage change from baseline
Standard Error 4.66
|
-48.14 percentage change from baseline
Standard Error 4.63
|
-34.96 percentage change from baseline
Standard Error 6.97
|
-44.71 percentage change from baseline
Standard Error 4.78
|
-31.95 percentage change from baseline
Standard Error 6.88
|
-42.49 percentage change from baseline
Standard Error 6.70
|
-35.67 percentage change from baseline
Standard Error 5.16
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksPatient's response to an air stimulus is recorded on a Dental Pain Scale (none\[1\]-mild\[2\]-moderate\[3\]-severe\[4\]).
Outcome measures
| Measure |
Test Toothpaste With Nano-HAP (Medium Concentration)
n=22 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (medium concentration)
|
Test Cream With Nano-HAP (Higher Concentration)
n=25 Participants
Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.
Test cream with nano-HAP (higher concentration)
|
Control Cream Without Nano-HAP
n=26 Participants
Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.
Control cream without nano-HAP
|
Control Toothpaste Containing Novamin® Technology
n=20 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Control toothpaste containing Novamin® technology
|
Control Toothpaste Containing 1500 Ppm Fluoride as MFP
n=20 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Control toothpaste containing 1500 ppm fluoride as MFP
|
Test Toothpaste With Nano-HAP (High Concentration)
n=19 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (high concentration)
|
Test Toothpaste With Nano-HAP (Low Concentration)
n=22 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (low concentration)
|
Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3)
n=24 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP and KNO3
|
Control Toothpaste Without Nano-HAP
n=20 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Control toothpaste without nano-HAP
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in DPS (Dental Pain Scale) With Air Stimulation
|
-49.35 percentage change from baseline
Standard Error 5.66
|
-17.47 percentage change from baseline
Standard Error 3.22
|
-28.54 percentage change from baseline
Standard Error 3.73
|
-35.14 percentage change from baseline
Standard Error 3.53
|
-43.35 percentage change from baseline
Standard Error 4.39
|
-34.15 percentage change from baseline
Standard Error 4.65
|
-38.63 percentage change from baseline
Standard Error 3.70
|
-43.95 percentage change from baseline
Standard Error 3.62
|
-33.63 percentage change from baseline
Standard Error 4.74
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksPatient's response to an cold stimulus is recorded on a Dental Pain Scale (none\[1\]-mild\[2\]-moderate\[3\]-severe\[4\]).
Outcome measures
| Measure |
Test Toothpaste With Nano-HAP (Medium Concentration)
n=22 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (medium concentration)
|
Test Cream With Nano-HAP (Higher Concentration)
n=25 Participants
Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.
Test cream with nano-HAP (higher concentration)
|
Control Cream Without Nano-HAP
n=26 Participants
Participants will be instructed to brush for 2 minutes morning and evening with a full ribbon of standard fluoride toothpaste. After the evening brushing, participants will then insert custom-made trays loaded with a full ribbon of cream. Participants will be instructed to remove the trays after 5 minutes and expectorate the cream. Participants will be instructed not to eat or drink until the next morning following cream use.
Control cream without nano-HAP
|
Control Toothpaste Containing Novamin® Technology
n=20 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Control toothpaste containing Novamin® technology
|
Control Toothpaste Containing 1500 Ppm Fluoride as MFP
n=20 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Control toothpaste containing 1500 ppm fluoride as MFP
|
Test Toothpaste With Nano-HAP (High Concentration)
n=19 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (high concentration)
|
Test Toothpaste With Nano-HAP (Low Concentration)
n=22 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP (low concentration)
|
Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3)
n=24 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Test toothpaste with nano-HAP and KNO3
|
Control Toothpaste Without Nano-HAP
n=20 Participants
Participants will be instructed to apply a full ribbon of toothpaste to a damp toothbrush. Participants will then brush for 2 minutes followed by rinsing with 15 mL of water. Participants will be instructed not to eat or drink for 30 minutes following brushing. Brushing will be performed twice a day (morning and evening).
Control toothpaste without nano-HAP
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in DPS (Dental Pain Scale) With Cold Stimulation
|
-46.21 percentage change from baseline
Standard Error 4.22
|
-15.30 percentage change from baseline
Standard Error 2.57
|
-25.57 percentage change from baseline
Standard Error 2.97
|
-35.37 percentage change from baseline
Standard Error 3.54
|
-30.18 percentage change from baseline
Standard Error 4.15
|
-39.81 percentage change from baseline
Standard Error 3.60
|
-38.41 percentage change from baseline
Standard Error 3.88
|
-35.03 percentage change from baseline
Standard Error 3.65
|
-34.07 percentage change from baseline
Standard Error 3.70
|
Adverse Events
Control Toothpaste Containing Novamin® Technology
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Toothpaste Containing 1500 Ppm Fluoride as MFP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Test Toothpaste With Nano-HAP (High Concentration)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Test Toothpaste With Nano-HAP (Low Concentration)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Toothpaste Without Nano-HAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Test Toothpaste With Nano-HAP (Medium Concentration)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Test Cream With Nano-HAP (Higher Concentration)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Cream Without Nano-HAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Bennett Amaechi, DDS
University of Texas Health San Antonio
Phone: 210-567-3185
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place