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| Name | Class |
|---|---|
| Dr. Kurt Wolff GmbH & Co. KG | INDUSTRY |
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This study tests the remineralization of donor teeth (donorMIH) in situ in participants using 10% hydroxyapatite (HAP) toothpaste and sodium fluoride toothpaste.
Prior to each 2-week treatment phase, subjects will complete a 1-week washout period. Following the washout period, the intra-oral appliance containing a donorMIH tooth block will be fitted to each subject by a qualified dentist. Immediately after fitting of the first appliance (on day 1 of the first treatment phase), each subject will receive a soft bristled manual toothbrush for use throughout the duration of the study and a toothpaste according to the treatment phase. Subjects will be instructed to brush their teeth with the appliance in the mouth, two times daily, for 3 minutes on each brushing episode, in the morning after breakfast and last thing before bed, then rinsing with 10 ml of water. Over the study period, all subjects will maintain their normal dietary habits.
A 7-day washout period without an appliance will follow. After completion of the second washout period, subjects will return to the clinic, and the appliance, with another MIH-bearing tooth blocks mounted, will be fitted to the subject for the phase 2 treatment period. This procedure will then be repeated until the 2-week treatment phase is completed, and each subject has gone through the two arms of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIH-bearing tooth block exposed to HAP toothpaste | Other | A block of molar incisor hypomineralization (MIH) is mounted in an oral appliance and fitted in the subject for testing with the HAP toothpaste |
|
| MIH-bearing block exposed to Sodium Fluoride toothpaste | Other | A block of molar incisor hypomineralization (MIH) is mounted in an oral appliance and fitted in the subject for testing with the sodium fluoride toothpaste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxyapatite toothpaste | Other | 10% Hydroxyapatite toothpaste |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mineral Density (MD) of Tooth | Images will be collected from the samples to measure the mineral density before and after remineralization treatment. Total number of subjects enrolled in either the first allocation or the second allocation after the washout are included. | Baseline to 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
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Subjects were consented and assessed for eligibility prior to inclusion into the study, and included adults over 18 years of age. Subjects were originally assigned to one of the toothpastes, then after using that toothpaste for 2 weeks, they were assigned to the other toothpaste.
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| ID | Title | Description |
|---|---|---|
| FG000 | MIH-bearing Tooth Block Exposed to HAP Toothpaste Then Sodium Fluoride Toothpaste | A block of molar incisor hypomineralization (MIH) is mounted in an oral appliance and fitted in the subject for testing with the HAP toothpaste followed by a washout period and then the sodium fluoride toothpaste. |
| FG001 | MIH-bearing Block Exposed to Sodium Fluoride Toothpaste Then the HAP Toothpaste | A block of molar incisor hypomineralization (MIH) is mounted in an oral appliance and fitted in the subject for testing with the sodium fluoride toothpaste then after a washout period, to the HAP toothpaste |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 Allocation |
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| Washout Period |
| |||||||||||||
| Phase 2 Allocation |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Enrollment | A block of molar incisor hypomineralization (MIH) is mounted in an oral appliance and fitted in the subject for testing with the HAP toothpaste. Subjects are randomized to either hydroxyapatite toothpaste (10%) or sodium flouride (1450 parts per million) toothpaste |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change in Mineral Density (MD) of Tooth | Images will be collected from the samples to measure the mineral density before and after remineralization treatment. Total number of subjects enrolled in either the first allocation or the second allocation after the washout are included. | Posted | Mean | Standard Deviation | percentage of remineralization | Baseline to 2 weeks |
|
From baseline to study end at 2 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 | MIH-bearing Tooth Block Exposed to HAP Toothpaste | A block of molar incisor hypomineralization (MIH) is mounted in an oral appliance and fitted in the subject for testing with the HAP toothpaste Hydroxyapatite toothpaste: 10% Hydroxyapatite toothpaste |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning | Gastrointestinal disorders | Non-systematic Assessment |
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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 | Jan 5, 2022 | Jan 4, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000094604 | Molar Hypomineralization |
| ID | Term |
|---|---|
| D000094603 | Dental Enamel Hypomineralization |
| D000094602 | Developmental Defects of Enamel |
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
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This is a double-blind, randomized, sequential, single center, controlled clinical trial.
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The study will be blinded to both the study team and the subjects.
| Sodium Fluoride Toothpaste | Other | 1450 parts per million sodium fluoride toothpaste |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
A block of molar incisor hypomineralization (MIH) is mounted in an oral appliance and fitted in the subject for testing with the sodium fluoride toothpaste
Sodium Fluoride Toothpaste: 1450 parts per million sodium fluoride toothpaste
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | MIH-bearing Block Exposed to Sodium Fluoride Toothpaste | A block of molar incisor hypomineralization (MIH) is mounted in an oral appliance and fitted in the subject for testing with the sodium fluoride toothpaste Sodium Fluoride Toothpaste: 1450 parts per million sodium fluoride toothpaste | 0 | 7 | 0 | 7 | 0 | 7 |
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| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |