Molar Incisor HypomineralizationNCT05485662
Remineralization of Molar Incisor Hypomineralization (MIH) With a Hydroxyapatite Toothpaste
A study testing Hydroxyapatite toothpaste and Sodium Fluoride Toothpaste in people with Molar Incisor Hypomineralization, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
This study tests the remineralization of donor teeth (donorMIH) in situ in participants using 10% hydroxyapatite (HAP) toothpaste and sodium fluoride toothpaste. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Hydroxyapatite toothpaste and Sodium Fluoride Toothpaste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2022to 9 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Dentistry, University of Texas Health Science Center
San Antonio, Texas, 78229
About this study
Official title: Remineralization of Molar Incisor Hypomineralization (MIH) With a Hydroxyapatite Toothpaste - an in Situ Study
This study tests the remineralization of donor teeth (donorMIH) in situ in participants using 10% hydroxyapatite (HAP) toothpaste and sodium fluoride toothpaste.
Read the 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.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Hydroxyapatite toothpaste, Sodium Fluoride Toothpaste
- Keywords
- Remineralization, Hydroxyapatite, Sodium fluoride
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxyapatite toothpasteOther
Also called HAP toothpaste
10% Hydroxyapatite toothpaste
Sodium Fluoride ToothpasteOther
Also called NaF toothpaste
1450 parts per million sodium fluoride toothpaste
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Hydroxyapatite 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 Receives: Other: Sodium Fluoride Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start6 Sep 2022
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Molar Incisor HypomineralizationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a double-blind, randomized, sequential, single center, controlled clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Kurt Wolff GmbH & Co. KG
- Responsible party
- Sponsor
- Investigators
- Bennett T Amaechi, BDS, MS, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485662
- Sponsor's protocol ID
- HSC20210570H
- Status last verified
- Apr 2024
- First submitted
- 1 Aug 2022
- Last updated
- 12 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remineralization of Molar Incisor Hypomineralization (MIH) With a Hydroxyapatite Toothpaste - an in Situ Study
- ClinicalTrials.gov ID
- NCT05485662
- Acronym / sponsor ID
- HSC20210570H
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- Remineralization, Hydroxyapatite, Sodium fluoride
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Dr. Kurt Wolff GmbH & Co. KG
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Posted 12 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a double-blind, randomized, sequential, single center, controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| MIH-bearing tooth block exposed to HAP toothpaste | Other | Other: Hydroxyapatite toothpasteA 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 | Other: Sodium Fluoride ToothpasteA block of molar incisor hypomineralization (MIH) is mounted in an oral appliance and fitted in the subject for testing with the sodium fluoride toothpaste |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxyapatite toothpasteAlso: HAP toothpaste10% Hydroxyapatite toothpaste | Other | MIH-bearing tooth block exposed to HAP toothpaste |
| Sodium Fluoride ToothpasteAlso: NaF toothpaste1450 parts per million sodium fluoride toothpaste | Other | MIH-bearing block exposed to Sodium Fluoride toothpaste |
Primary outcome
Change in Mineral Density (MD) of Tooth
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bennett T Amaechi, BDS, MS, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxyapatite toothpaste and Sodium Fluoride Toothpaste in people with Molar Incisor Hypomineralization, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mineral Density (MD) of Tooth (time frame: Baseline to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.