Molar Incisor Hypomineralization
Conditions
Keywords
Remineralization, Hydroxyapatite, Sodium fluoride
Brief summary
This study tests the remineralization of donor teeth (donorMIH) in situ in participants using 10% hydroxyapatite (HAP) toothpaste and sodium fluoride toothpaste.
Detailed description
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.
Interventions
10% Hydroxyapatite toothpaste
1450 parts per million sodium fluoride toothpaste
Sponsors
Dr. Kurt Wolff GmbH & Co. KG
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
The study will be blinded to both the study team and the subjects.
Intervention model description
This is a double-blind, randomized, sequential, single center, controlled clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-60 years of age * Good general health * No known history of allergy to personal care/consumer products * Minimum of 20 natural uncrowned teeth (excluding third molars) * Normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥0.2 ml/min respectively * Able to consent * Availability throughout entire study * Willing to wear intra-oral appliance 24 hours per day * Willing to use only assigned products for oral hygiene for duration of study
Exclusion criteria
* Advanced periodontal disease * A medical condition that requires pre-medication prior to dental visits/procedures * Impaired salivary function * Orthodontic retainer(s) * Too few teeth to secure the oral appliance * Disease of the soft or hard oral tissues * Use of drugs that can affect salivary flow * Use of antibiotics one month prior to or during this study * Participation in another clinical study one week prior to the start of washout period or during this study period * Allergic hisotry to common toothpaste ingredients * Compromised immune system (HIV, AIDS, Immunosuppressive drug therapy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mineral Density (MD) of Tooth | Baseline to 2 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Overall Study Enrollment |
|---|---|
| Age, Continuous | 50.2 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 0 / 8 | 0 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 |
Outcome results
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.
Time frame: Baseline to 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIH-bearing Tooth Block Exposed to HAP Toothpaste | Change in Mineral Density (MD) of Tooth | Combined data | 26.02 percentage of remineralization | Standard Deviation 20.68 |
| MIH-bearing Tooth Block Exposed to HAP Toothpaste | Change in Mineral Density (MD) of Tooth | Etched | 29.26 percentage of remineralization | Standard Deviation 22.99 |
| MIH-bearing Tooth Block Exposed to HAP Toothpaste | Change in Mineral Density (MD) of Tooth | Unetched | 16.62 percentage of remineralization | Standard Deviation 5.74 |
| MIH-bearing Block Exposed to Sodium Fluoride Toothpaste | Change in Mineral Density (MD) of Tooth | Combined data | 14.64 percentage of remineralization | Standard Deviation 9.6 |
| MIH-bearing Block Exposed to Sodium Fluoride Toothpaste | Change in Mineral Density (MD) of Tooth | Etched | 16.83 percentage of remineralization | Standard Deviation 9.97 |
| MIH-bearing Block Exposed to Sodium Fluoride Toothpaste | Change in Mineral Density (MD) of Tooth | Unetched | 10.62 percentage of remineralization | Standard Deviation 8.13 |