Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 26 of 32 for:    FLUORIDE ION AND NITRATE ION

Clinical Efficacy in Relieving Dentin Hypersensitivity of Nanohydroxyapatite-Containing Toothpastes and Cream

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02918617
Recruitment Status : Completed
First Posted : September 29, 2016
Results First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Collaborator:
Sangi Co., Ltd.
Information provided by (Responsible Party):
Bennett Amaechi, The University of Texas Health Science Center at San Antonio

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dentin Sensitivity
Interventions Drug: Control toothpaste containing Novamin® technology
Drug: Control toothpaste containing 1500 ppm fluoride as MFP
Drug: Test toothpaste with nano-HAP (high concentration)
Drug: Test toothpaste with nano-HAP (low concentration)
Drug: Test toothpaste with nano-HAP and (Potassium Nitrate) KNO3
Drug: Control toothpaste without nano-HAP
Drug: Test toothpaste with nano-HAP (medium concentration)
Drug: Test cream with nano-HAP (higher concentration)
Drug: Control cream without nano-HAP
Enrollment 203
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Toothpaste Containing Novamin® Technology Control Toothpaste Containing 1500 Ppm Fluoride as MFP Test Toothpaste With Nano-HAP (High Concentration) Test Toothpaste With Nano-HAP (Low Concentration) Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3) Control Toothpaste Without Nano-HAP Test Toothpaste With Nano-HAP (Medium Concentration) Test Cream With Nano-HAP (Higher Concentration) Control Cream Without Nano-HAP
Hide Arm/Group Description

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

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

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)

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)

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

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

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)

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)

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

Period Title: Overall Study
Started 21 20 22 22 24 20 22 26 26
Completed 20 20 19 22 24 20 22 25 26
Not Completed 1 0 3 0 0 0 0 1 0
Arm/Group Title Control Toothpaste Containing Novamin® Technology Control Toothpaste Containing 1500 Ppm Fluoride as MFP Test Toothpaste With Nano-HAP (High Concentration) Test Toothpaste With Nano-HAP (Low Concentration) Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3) Control Toothpaste Without Nano-HAP Test Toothpaste With Nano-HAP (Medium Concentration) Test Cream With Nano-HAP (Higher Concentration) Control Cream Without Nano-HAP Total
Hide Arm/Group Description

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

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

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)

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)

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

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

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)

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)

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 of all reporting groups
Overall Number of Baseline Participants 20 20 19 22 24 20 22 25 26 198
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 19 participants 22 participants 24 participants 20 participants 22 participants 25 participants 26 participants 198 participants
49.3  (10.5) 45.85  (15.76) 53.6  (11.0) 52.8  (11.2) 43.7  (12.8) 45.35  (11.37) 47.14  (14.54) 41.4  (14.14) 49.38  (10.62) 47.61  (12.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 19 participants 22 participants 24 participants 20 participants 22 participants 25 participants 26 participants 198 participants
Female
15
  75.0%
14
  70.0%
18
  94.7%
16
  72.7%
18
  75.0%
13
  65.0%
17
  77.3%
19
  76.0%
22
  84.6%
152
  76.8%
Male
5
  25.0%
6
  30.0%
1
   5.3%
6
  27.3%
6
  25.0%
7
  35.0%
5
  22.7%
6
  24.0%
4
  15.4%
46
  23.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Ethnicity Number Analyzed 20 participants 20 participants 19 participants 22 participants 24 participants 20 participants 22 participants 25 participants 26 participants 198 participants
Asian or Pacific Islander
3
  15.0%
0
   0.0%
0
   0.0%
1
   4.5%
0
   0.0%
2
  10.0%
4
  18.2%
1
   4.0%
3
  11.5%
14
   7.1%
Black not Hispanic
1
   5.0%
0
   0.0%
1
   5.3%
2
   9.1%
0
   0.0%
2
  10.0%
1
   4.5%
4
  16.0%
4
  15.4%
15
   7.6%
Hispanic
8
  40.0%
15
  75.0%
13
  68.4%
12
  54.5%
15
  62.5%
10
  50.0%
11
  50.0%
13
  52.0%
14
  53.8%
111
  56.1%
Other
2
  10.0%
0
   0.0%
1
   5.3%
3
  13.6%
2
   8.3%
1
   5.0%
0
   0.0%
0
   0.0%
1
   3.8%
10
   5.1%
White not Hispanic
6
  30.0%
5
  25.0%
4
  21.1%
4
  18.2%
7
  29.2%
5
  25.0%
6
  27.3%
7
  28.0%
4
  15.4%
48
  24.2%
1.Primary Outcome
Title Percentage Change From Baseline in VAS (Visual Analog Scale) With Air Stimulation
Hide Description 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.
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Toothpaste Containing Novamin® Technology Control Toothpaste Containing 1500 Ppm Fluoride as MFP Test Toothpaste With Nano-HAP (High Concentration) Test Toothpaste With Nano-HAP (Low Concentration) Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3) Control Toothpaste Without Nano-HAP Test Toothpaste With Nano-HAP (Medium Concentration) Test Cream With Nano-HAP (Higher Concentration) Control Cream Without Nano-HAP
Hide Arm/Group Description:

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

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

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)

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)

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

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

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)

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)

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 Number of Participants Analyzed 20 20 19 22 24 20 22 25 26
Mean (Standard Error)
Unit of Measure: percentage change from baseline
-51.44  (5.31) -51.59  (5.57) -41.59  (8.08) -38.64  (5.85) -53.16  (5.99) -47.19  (7.13) -56.85  (7.98) -38.99  (5.37) -50.67  (4.93)
2.Primary Outcome
Title Percentage Change From Baseline in VAS (Visual Analog Scale) With Cold Stimulation
Hide Description Patient'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
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Toothpaste Containing Novamin® Technology Control Toothpaste Containing 1500 Ppm Fluoride as MFP Test Toothpaste With Nano-HAP (High Concentration) Test Toothpaste With Nano-HAP (Low Concentration) Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3) Control Toothpaste Without Nano-HAP Test Toothpaste With Nano-HAP (Medium Concentration) Test Cream With Nano-HAP (Higher Concentration) Control Cream Without Nano-HAP
Hide Arm/Group Description:

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

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

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)

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)

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

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

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)

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)

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 Number of Participants Analyzed 20 20 19 22 24 20 22 25 26
Mean (Standard Error)
Unit of Measure: percentage change from baseline
-48.14  (4.63) -34.96  (6.97) -44.71  (4.78) -31.95  (6.88) -42.49  (6.70) -35.67  (5.16) -48.80  (6.21) -34.90  (3.4) -39.36  (4.66)
3.Primary Outcome
Title Percentage Change From Baseline in DPS (Dental Pain Scale) With Air Stimulation
Hide Description Patient's response to an air stimulus is recorded on a Dental Pain Scale (none[1]-mild[2]-moderate[3]-severe[4]).
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Toothpaste Containing Novamin® Technology Control Toothpaste Containing 1500 Ppm Fluoride as MFP Test Toothpaste With Nano-HAP (High Concentration) Test Toothpaste With Nano-HAP (Low Concentration) Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3) Control Toothpaste Without Nano-HAP Test Toothpaste With Nano-HAP (Medium Concentration) Test Cream With Nano-HAP (Higher Concentration) Control Cream Without Nano-HAP
Hide Arm/Group Description:

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

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

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)

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)

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

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

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)

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)

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 Number of Participants Analyzed 20 20 19 22 24 20 22 25 26
Mean (Standard Error)
Unit of Measure: percentage change from baseline
-35.14  (3.53) -43.35  (4.39) -34.15  (4.65) -38.63  (3.70) -43.95  (3.62) -33.63  (4.74) -49.35  (5.66) -17.47  (3.22) -28.54  (3.73)
4.Primary Outcome
Title Percentage Change From Baseline in DPS (Dental Pain Scale) With Cold Stimulation
Hide Description Patient's response to an cold stimulus is recorded on a Dental Pain Scale (none[1]-mild[2]-moderate[3]-severe[4]).
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Toothpaste Containing Novamin® Technology Control Toothpaste Containing 1500 Ppm Fluoride as MFP Test Toothpaste With Nano-HAP (High Concentration) Test Toothpaste With Nano-HAP (Low Concentration) Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3) Control Toothpaste Without Nano-HAP Test Toothpaste With Nano-HAP (Medium Concentration) Test Cream With Nano-HAP (Higher Concentration) Control Cream Without Nano-HAP
Hide Arm/Group Description:

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

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

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)

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)

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

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

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)

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)

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 Number of Participants Analyzed 20 20 19 22 24 20 22 25 26
Mean (Standard Error)
Unit of Measure: percentage change from baseline
-35.37  (3.54) -30.18  (4.15) -39.81  (3.60) -38.41  (3.88) -35.03  (3.65) -34.07  (3.70) -46.21  (4.22) -15.30  (2.57) -25.57  (2.97)
Time Frame Baseline to 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Toothpaste Containing Novamin® Technology Control Toothpaste Containing 1500 Ppm Fluoride as MFP Test Toothpaste With Nano-HAP (High Concentration) Test Toothpaste With Nano-HAP (Low Concentration) Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3) Control Toothpaste Without Nano-HAP Test Toothpaste With Nano-HAP (Medium Concentration) Test Cream With Nano-HAP (Higher Concentration) Control Cream Without Nano-HAP
Hide Arm/Group Description

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

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

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)

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)

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

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

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)

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)

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

All-Cause Mortality
Control Toothpaste Containing Novamin® Technology Control Toothpaste Containing 1500 Ppm Fluoride as MFP Test Toothpaste With Nano-HAP (High Concentration) Test Toothpaste With Nano-HAP (Low Concentration) Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3) Control Toothpaste Without Nano-HAP Test Toothpaste With Nano-HAP (Medium Concentration) Test Cream With Nano-HAP (Higher Concentration) Control Cream Without Nano-HAP
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%)   0/22 (0.00%)   0/20 (0.00%)   0/21 (0.00%)   0/20 (0.00%)   0/22 (0.00%)   0/25 (0.00%)   0/26 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Control Toothpaste Containing Novamin® Technology Control Toothpaste Containing 1500 Ppm Fluoride as MFP Test Toothpaste With Nano-HAP (High Concentration) Test Toothpaste With Nano-HAP (Low Concentration) Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3) Control Toothpaste Without Nano-HAP Test Toothpaste With Nano-HAP (Medium Concentration) Test Cream With Nano-HAP (Higher Concentration) Control Cream Without Nano-HAP
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%)   0/22 (0.00%)   0/20 (0.00%)   0/21 (0.00%)   0/20 (0.00%)   0/22 (0.00%)   0/26 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Toothpaste Containing Novamin® Technology Control Toothpaste Containing 1500 Ppm Fluoride as MFP Test Toothpaste With Nano-HAP (High Concentration) Test Toothpaste With Nano-HAP (Low Concentration) Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3) Control Toothpaste Without Nano-HAP Test Toothpaste With Nano-HAP (Medium Concentration) Test Cream With Nano-HAP (Higher Concentration) Control Cream Without Nano-HAP
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%)   0/22 (0.00%)   0/20 (0.00%)   0/21 (0.00%)   0/20 (0.00%)   0/22 (0.00%)   0/26 (0.00%)   0/26 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bennett Amaechi, DDS
Organization: University of Texas Health San Antonio
Phone: 210-567-3185
EMail: amaechi@uthscsa.edu
Layout table for additonal information
Responsible Party: Bennett Amaechi, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02918617     History of Changes
Other Study ID Numbers: HSC20150221H
First Submitted: September 13, 2016
First Posted: September 29, 2016
Results First Submitted: August 21, 2018
Results First Posted: November 16, 2018
Last Update Posted: November 16, 2018