Trial Outcomes & Findings for Remineralization of Molar Incisor Hypomineralization (MIH) With a Hydroxyapatite Toothpaste (NCT NCT05485662)
NCT ID: NCT05485662
Last Updated: 2024-04-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Baseline to 2 weeks
Results posted on
2024-04-12
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Phase 1 Allocation
STARTED
|
8
|
7
|
|
Phase 1 Allocation
COMPLETED
|
8
|
7
|
|
Phase 1 Allocation
NOT COMPLETED
|
0
|
0
|
|
Washout Period
STARTED
|
8
|
7
|
|
Washout Period
COMPLETED
|
8
|
7
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
|
Phase 2 Allocation
STARTED
|
7
|
8
|
|
Phase 2 Allocation
COMPLETED
|
7
|
8
|
|
Phase 2 Allocation
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Remineralization of Molar Incisor Hypomineralization (MIH) With a Hydroxyapatite Toothpaste
Baseline characteristics by cohort
| Measure |
Overall Study Enrollment
n=15 Participants
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
|
|---|---|
|
Age, Continuous
|
50.2 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2 weeksImages 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.
Outcome measures
| Measure |
MIH-bearing Tooth Block Exposed to HAP Toothpaste
n=15 Participants
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
|
MIH-bearing Block Exposed to Sodium Fluoride Toothpaste
n=15 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
|
|---|---|---|
|
Change in Mineral Density (MD) of Tooth
Combined data
|
26.02 percentage of remineralization
Standard Deviation 20.68
|
14.64 percentage of remineralization
Standard Deviation 9.60
|
|
Change in Mineral Density (MD) of Tooth
Etched
|
29.26 percentage of remineralization
Standard Deviation 22.99
|
16.83 percentage of remineralization
Standard Deviation 9.97
|
|
Change in Mineral Density (MD) of Tooth
Unetched
|
16.62 percentage of remineralization
Standard Deviation 5.74
|
10.62 percentage of remineralization
Standard Deviation 8.13
|
Adverse Events
MIH-bearing Tooth Block Exposed to HAP Toothpaste
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MIH-bearing Block Exposed to Sodium Fluoride Toothpaste
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MIH-bearing Tooth Block Exposed to HAP Toothpaste
n=8 participants at risk
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
|
MIH-bearing Block Exposed to Sodium Fluoride Toothpaste
n=7 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Burning
|
0.00%
0/8 • From baseline to study end at 2 weeks
|
0.00%
0/7 • From baseline to study end at 2 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place