An interventional study of Hydroxyapatite toothpaste and Sodium Fluoride Toothpaste in Molar Incisor Hypomineralization, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Other
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.
121 studies on the registry are indexed under Molar Hypomineralization; 41 are open to participants now.
This study's enrollment of 15 is below the median of 52 across 94 interventional studies indexed under Molar Hypomineralization.
Browse Molar Hypomineralization studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
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Exclusion Criteria:
A block of molar incisor hypomineralization (MIH) is mounted in an oral appliance and fitted in the subject for testing with the HAP toothpaste
Other: Hydroxyapatite 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
Other: Sodium Fluoride Toothpaste
10% Hydroxyapatite toothpaste
Also known as: HAP toothpaste
1450 parts per million sodium fluoride toothpaste
Also known as: NaF toothpaste
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.
Time frame: Baseline to 2 weeks
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.
| Milestone | MIH-bearing Tooth Block Exposed to HAP Toothpaste Then Sodium Fluoride Toothpaste | MIH-bearing Block Exposed to Sodium Fluoride Toothpaste Then the HAP Toothpaste |
|---|---|---|
| Started | 8 | 7 |
| Completed | 8 | 7 |
| Not completed | 0 | 0 |
| Milestone | MIH-bearing Tooth Block Exposed to HAP Toothpaste Then Sodium Fluoride Toothpaste | MIH-bearing Block Exposed to Sodium Fluoride Toothpaste Then the HAP Toothpaste |
|---|---|---|
| Started | 8 | 7 |
| Completed | 8 | 7 |
| Not completed | 0 | 0 |
| Milestone | MIH-bearing Tooth Block Exposed to HAP Toothpaste Then Sodium Fluoride Toothpaste | MIH-bearing Block Exposed to Sodium Fluoride Toothpaste Then the HAP Toothpaste |
|---|---|---|
| Started | 7 | 8 |
| Completed | 7 | 8 |
| Not completed | 0 | 0 |
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.
| percentage of remineralization | MIH-bearing Tooth Block Exposed to HAP Toothpaste | MIH-bearing Block Exposed to Sodium Fluoride Toothpaste |
|---|---|---|
| Combined data | 26.02 ± 20.68 | 14.64 ± 9.60 |
| Etched | 29.26 ± 22.99 | 16.83 ± 9.97 |
| Unetched | 16.62 ± 5.74 | 10.62 ± 8.13 |
Collected over From baseline to study end at 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MIH-bearing Tooth Block Exposed to HAP Toothpaste | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| MIH-bearing Block Exposed to Sodium Fluoride Toothpaste | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Event | MIH-bearing Tooth Block Exposed to HAP Toothpaste | MIH-bearing Block Exposed to Sodium Fluoride Toothpaste |
|---|---|---|
| BurningGastrointestinal disorders | — | — |
| Age, Continuous(years) | Overall Study Enrollment |
|---|---|
| Mean | 50.2 (25 to 67) |
| Sex: Female, Male(Participants) | Overall Study Enrollment |
|---|---|
| Female | 14 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Overall Study Enrollment |
|---|---|
| Hispanic or Latino | 10 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Overall Study Enrollment |
|---|---|
| United States | 15 |
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The University of Texas Health Science Center at San Antonio