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| Name | Class |
|---|---|
| Sangi Co., Ltd. | INDUSTRY |
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This study will investigate the effectiveness of nanohydroxyapatite (nano-HAP)-containing toothpastes and cream to relieve dentin hypersensitivity, comparing it with those of a commercial desensitizing dentifrice containing calcium sodium phosphosilicate (Novamin® technology) and a standard fluoride dentifrice containing 1,500 ppm fluoride as sodium monofluorophosphate (MFP).
This is a double-blind, randomized, controlled, parallel group, outpatient clinical trial, involving a total of 270 patients diagnosed with dentin hypersensitivity, who will be randomly assigned to nine treatment groups of 30 patients each. Males or females of age 18 to 80 years will be enrolled. The nine groups will be randomly assigned to use one of the nine test products: (1) toothpaste containing nano-HAP (high concentration); (2) toothpaste containing nano-HAP (low concentration); (3) toothpaste containing nano-HAP and potassium nitrate (KNO3); (4) toothpaste containing NovaMin; (5) standard fluoride toothpaste with 1500 ppm MFP; (6) toothpaste containing nano-HAP (medium concentration); (7) placebo toothpaste; (8) cream containing nano-HAP; (9) placebo cream. Subjects will be instructed to use the study toothpaste as their sole oral hygiene product for the 8 weeks treatment duration while the cream will be applied with a retainer tray for 5 minutes before bed at night. For those using toothpastes, subjects will be instructed to brush their teeth twice daily for 2 minutes, morning and last thing before bed, applying on each occasion a one-inch strip of their assigned toothpaste on a wetted commercially available soft-bristled toothbrush. Dentin hypersensitivity examination, which will include air blast sensitivity and cold thermal sensitivity combined with visual analog scale and Dental Pain Scale, will be conducted at baseline, 2, 4, 6, and 8 weeks. Subjects will be screened for adverse effects on every visit, and all observed adverse events will be recorded when they occur.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control toothpaste containing Novamin® technology | Active Comparator | 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 | Placebo Comparator | 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) | Experimental | 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) | Experimental | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control toothpaste containing Novamin® technology | Drug |
| ||
| Control toothpaste containing 1500 ppm fluoride as MFP |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in VAS (Visual Analog Scale) With Air Stimulation | 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. | Baseline to 8 weeks |
| Percentage Change From Baseline in VAS (Visual Analog Scale) With Cold Stimulation | 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 | Baseline to 8 weeks |
| Percentage Change From Baseline in DPS (Dental Pain Scale) With Air Stimulation | Patient's response to an air stimulus is recorded on a Dental Pain Scale (none[1]-mild[2]-moderate[3]-severe[4]). | Baseline to 8 weeks |
| Percentage Change From Baseline in DPS (Dental Pain Scale) With Cold Stimulation | Patient's response to an cold stimulus is recorded on a Dental Pain Scale (none[1]-mild[2]-moderate[3]-severe[4]). | Baseline to 8 weeks |
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Inclusion Criteria:
Must be between the ages of 18 and 80, inclusive
Must be in good general health based on medical history and oral soft and hard tissue examinations
Must be willing and able to provide informed consent
Must be able to read and comprehend study materials
Must have access to a phone for regular study contact
Must be willing to use the assigned products according to instructions, and be availability for appointments.
Must have been diagnosed of having dentin hypersensitivity by a dentist, with at least one sensitive tooth with demonstrated cervical erosion/abrasion or gingival recession
As a final entrance criteria, the sensitive tooth must respond to:
Exclusion Criteria:
Subjects who answer YES to any of the following questions will not be enrolled into the study:
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| Name | Affiliation | Role |
|---|---|---|
| Bennett T Amaechi, BDS, MS, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dentistry, University of Texas Health Science Center | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2197126 | Background | Clark GE, Troullos ES. Designing hypersensitivity clinical studies. Dent Clin North Am. 1990 Jul;34(3):531-44. | |
| 8951626 | Background | Gillam DG, Bulman JS, Jackson RJ, Newman HN. Efficacy of a potassium nitrate mouthwash in alleviating cervical dentine sensitivity (CDS). J Clin Periodontol. 1996 Nov;23(11):993-7. doi: 10.1111/j.1600-051x.1996.tb00526.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Test toothpaste with nano-HAP and potassium nitrate (KNO3) | Experimental | 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 | Placebo Comparator | 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) | Experimental | 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 cream with nano-HAP (higher concentration) | Experimental | 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 | Placebo Comparator | 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. |
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| Drug |
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| Test toothpaste with nano-HAP (high concentration) | Drug |
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| Test toothpaste with nano-HAP (low concentration) | Drug |
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| Test toothpaste with nano-HAP and (Potassium Nitrate) KNO3 | Drug |
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| Control toothpaste without nano-HAP | Drug |
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| Test toothpaste with nano-HAP (medium concentration) | Drug |
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| Test cream with nano-HAP (higher concentration) | Drug |
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| Control cream without nano-HAP | Drug |
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| Background | Kakar A. A novel computer program for visual analogue scale (VAS). Journal of Dental Research 88 (Special Issue A): 1952, 2009. |
| 4139420 | Background | Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available. |
| 8534379 | Background | Orro M, Truong T, De Vizio W, Miller S, Chu TC, Boylan D. Thermodontic stimulator--a new technology for assessment of thermal dentinal hypersensitivity. J Clin Dent. 1994;5 Spec No:83-6. |
| 8534380 | Background | Schiff T, Dotson M, Cohen S, De Vizio W, McCool J, Volpe A. Efficacy of a dentifrice containing potassium nitrate, soluble pyrophosphate, PVM/MA copolymer, and sodium fluoride on dentinal hypersensitivity: a twelve-week clinical study. J Clin Dent. 1994;5 Spec No:87-92. |
| 19831164 | Background | Ayad F, Ayad N, Delgado E, Zhang YP, DeVizio W, Cummins D, Mateo LR. Comparing the efficacy in providing instant relief of dentin hypersensitivity of a new toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride to a benchmark desensitizing toothpaste containing 2% potassium ion and 1450 ppm fluoride, and to a control toothpaste with 1450 ppm fluoride: a three-day clinical study in Mississauga, Canada. J Clin Dent. 2009;20(4):115-22. |
| FG001 | 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 |
| FG002 | 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) |
| FG003 | 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) |
| FG004 | 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 |
| FG005 | 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 |
| FG006 | 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) |
| FG007 | 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) |
| FG008 | 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 |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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) |
| BG003 | 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) |
| BG004 | 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 |
| BG005 | 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 |
| BG006 | 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) |
| BG007 | 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) |
| BG008 | 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 |
| BG009 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change From Baseline in VAS (Visual Analog Scale) With Air Stimulation | 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. | Posted | Mean | Standard Error | percentage change from baseline | Baseline to 8 weeks |
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| Primary | Percentage Change From Baseline in VAS (Visual Analog Scale) With Cold Stimulation | 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 | Posted | Mean | Standard Error | percentage change from baseline | Baseline to 8 weeks |
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| Primary | Percentage Change From Baseline in DPS (Dental Pain Scale) With Air Stimulation | Patient's response to an air stimulus is recorded on a Dental Pain Scale (none[1]-mild[2]-moderate[3]-severe[4]). | Posted | Mean | Standard Error | percentage change from baseline | Baseline to 8 weeks |
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| Primary | Percentage Change From Baseline in DPS (Dental Pain Scale) With Cold Stimulation | Patient's response to an cold stimulus is recorded on a Dental Pain Scale (none[1]-mild[2]-moderate[3]-severe[4]). | Posted | Mean | Standard Error | percentage change from baseline | Baseline to 8 weeks |
|
Baseline to 8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 21 | 0 | 21 | 0 | 21 |
| EG001 | 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 | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | 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) | 0 | 22 | 0 | 22 | 0 | 22 |
| EG003 | 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) | 0 | 20 | 0 | 20 | 0 | 20 |
| EG004 | 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 | 0 | 21 | 0 | 21 | 0 | 21 |
| EG005 | 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 | 0 | 20 | 0 | 20 | 0 | 20 |
| EG006 | 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) | 0 | 22 | 0 | 22 | 0 | 22 |
| EG007 | 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) | 0 | 25 | 0 | 26 | 0 | 26 |
| EG008 | 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 | 0 | 26 | 0 | 26 | 0 | 26 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bennett Amaechi, DDS | University of Texas Health San Antonio | 210-567-3185 | amaechi@uthscsa.edu |
| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C023844 | potassium nitrate |
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| Male |
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| Black not Hispanic |
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| Hispanic |
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| Other |
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| White not Hispanic |
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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)
| OG003 | 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) |
| OG004 | 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 |
| OG005 | 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 |
| OG006 | 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) |
| OG007 | 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) |
| OG008 | 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 |
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| OG003 | 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) |
| OG004 | 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 |
| OG005 | 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 |
| OG006 | 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) |
| OG007 | 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) |
| OG008 | 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 |
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| OG003 | 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) |
| OG004 | 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 |
| OG005 | 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 |
| OG006 | 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) |
| OG007 | 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) |
| OG008 | 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 |
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