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| Name | Class |
|---|---|
| Sangi Co., Ltd. | INDUSTRY |
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Subjects will be enrolled into 3 balanced groups each using a different strength toothpaste. Dental hypersensitivity (DHS) will be assessed at study start, midway and study end.
This study is a double-blind, randomized, placebo-and positive-controlled, stratified parallel group clinical trial. The three groups will be randomly assigned to use one of three test toothpastes having an identical base formulation but containing respectively either 0% nano-hydroxyapatite (HAP) (placebo), 15% nano-HAP or 5% KNO3 (positive control). All dental examinations for data collection will be conducted by the same Clinical Examiner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toothpaste 1 | Active Comparator | Toothpaste 3 containing 5% potassium nitrate (KNO3) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush. |
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| Toothpaste 2 | Active Comparator | Toothpaste 2 containing 15% nano-HAP will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush. |
|
| Toothpaste 3 | Placebo Comparator | Toothpaste 1 containing 0% nano-hydroxyapatite (HAP) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | 0% nano-HAP toothpaste |
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| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Cold Air Stimulus | The primary efficacy outcome will be the decrease in cold air stimulus sensitivity (VAS score) from baseline to 8 weeks. Assessment of change in cold air sensitivity will be conducted using air delivered from a standard dental unit air syringe at room temperature (~70°F±3°F)(~21°C±2°C) and a pressure of 60psi (± 5psi). Assessment of sensitivity will be carried out using Visual Analog Scale (VAS). Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. | Week 0 (baseline), 4 weeks and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Tactile Stimulus | The secondary efficacy outcome will be the increase in tactile stimulus force from baseline to 8 weeks. Assessment of Change in tactile sensitivity will be assessed using the Yeaple Electronic Force Sensing Probe.The explorer tip will be applied perpendicular to the tooth surface and a pressure load applied starting at 10 g and increasing to 80g. The load at which the subject says "yes" will be recorded. (Baseline screening will begin at 30g). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bennett T Amaechi, BDS, MS, PhD | University of Texas Health 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 |
Individual participant data will be shared as de-identified data as summary results reported in ClinicalTrials.gov and in journal publication.
Data will be available at study completion
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Subjects were consented and enrolled, then for one month there was a washout period. Baseline characteristic measurements were taken prior to washout for both Cold Air Sensitivity and Tactile Stimulus.
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| ID | Title | Description |
|---|---|---|
| FG000 | Toothpaste 1 | Toothpaste 1 containing 0% nano-hydroxyapatite (HAP) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush. Placebo: 0% nano-HAP toothpaste |
| FG001 | Toothpaste 2 | Toothpaste 2 containing 15% nano-HAP will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush. 15% nano-HAP toothpaste: Toothpaste with identical base formulation as the placebo containing 15% nano-HAP |
| FG002 | Toothpaste 3 | Toothpaste 3 containing 5% potassium nitrate (KNO3) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush. 5% KNO3 toothpaste: Toothpaste with identical base formulation as the placebo containing 5% KNO3 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Washout Period |
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| Treatment Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Toothpaste 1 | Toothpaste 1 containing 0% nano-hydroxyapatite (HAP) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush. Placebo: 0% nano-HAP toothpaste |
| BG001 |
| 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 |
| 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 | Measurement of Cold Air Stimulus | The primary efficacy outcome will be the decrease in cold air stimulus sensitivity (VAS score) from baseline to 8 weeks. Assessment of change in cold air sensitivity will be conducted using air delivered from a standard dental unit air syringe at room temperature (~70°F±3°F)(~21°C±2°C) and a pressure of 60psi (± 5psi). Assessment of sensitivity will be carried out using Visual Analog Scale (VAS). Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. | Posted | Mean | Standard Deviation | units on a scale | Week 0 (baseline), 4 weeks and 8 weeks |
|
Study start to 8 weeks
Adverse events related to study participation were collected.
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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 | Toothpaste 1 | Toothpaste 3 containing 5% potassium nitrate (KNO3) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush. 5% KNO3 toothpaste: Toothpaste with identical base formulation as the placebo containing 5% KNO3 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bennett Amaechi BDS, MD, PhD | UT Health San Antonio | 210 567 3185 | amaechi@uthscsa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2020 | Mar 31, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| 15% nano-HAP toothpaste | Device | Toothpaste with identical base formulation as the placebo containing 15% nano-HAP |
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| 5% KNO3 toothpaste | Device | Toothpaste with identical base formulation as the placebo containing 5% KNO3 |
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| Week 0 (baseline), 4 weeks and 8 weeks |
| NOT COMPLETED |
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|
| Toothpaste 2 |
Toothpaste 2 containing 15% nano-HAP will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush. 15% nano-HAP toothpaste: Toothpaste with identical base formulation as the placebo containing 15% nano-HAP |
| BG002 | Toothpaste 3 | Toothpaste 3 containing 5% potassium nitrate (KNO3) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush. 5% KNO3 toothpaste: Toothpaste with identical base formulation as the placebo containing 5% KNO3 |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Cold Air Sensitivity (VAS) | Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. This measurement was taken prior to the participant wash-out period | Mean | Standard Deviation | units on a scale |
|
| Tactile (g) | The secondary efficacy outcome will be the increase in tactile stimulus force from baseline to 8 weeks. Assessment of Change in tactile sensitivity will be assessed using the Yeaple Electronic Force Sensing Probe.The explorer tip will be applied perpendicular to the tooth surface and a pressure load applied starting at 10 g and increasing to 80g. The load at which the subject says "yes" will be recorded. (Baseline screening will begin at 30g) This measurement was taken prior to washout period. | Mean | Standard Deviation | grams |
|
| OG001 | Toothpaste 2 | Toothpaste 2 containing 15% nano-HAP will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush. 15% nano-HAP toothpaste: Toothpaste with identical base formulation as the placebo containing 15% nano-HAP |
| OG002 | Toothpaste 3 | Toothpaste 1 containing 0% nano-hydroxyapatite (HAP) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush. Placebo: 0% nano-HAP toothpaste |
|
|
| Secondary | Measurement of Tactile Stimulus | The secondary efficacy outcome will be the increase in tactile stimulus force from baseline to 8 weeks. Assessment of Change in tactile sensitivity will be assessed using the Yeaple Electronic Force Sensing Probe.The explorer tip will be applied perpendicular to the tooth surface and a pressure load applied starting at 10 g and increasing to 80g. The load at which the subject says "yes" will be recorded. (Baseline screening will begin at 30g). | Posted | Mean | Standard Deviation | Grams | Week 0 (baseline), 4 weeks and 8 weeks |
|
|
|
| 0 |
| 64 |
| 0 |
| 64 |
| 0 |
| 64 |
| EG001 | Toothpaste 2 | Toothpaste 2 containing 15% nano-HAP will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush. 15% nano-HAP toothpaste: Toothpaste with identical base formulation as the placebo containing 15% nano-HAP | 0 | 64 | 0 | 64 | 0 | 64 |
| EG002 | Toothpaste 3 | Toothpaste 1 containing 0% nano-hydroxyapatite (HAP) will be used by subjects to brush their teeth twice daily for 3 minutes in the morning and before bed each night using a 1 inch strip of toothpaste on a soft-bristled toothbrush. Placebo: 0% nano-HAP toothpaste | 0 | 64 | 0 | 64 | 0 | 64 |
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| 8 weeks |
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