Clinical Efficacy of Biomimetic Hydroxyapatite in the Treatment of Molar Incisor Hypomineralization.
NCT ID: NCT04808180
Last Updated: 2022-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2021-03-25
2022-02-01
Brief Summary
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Detailed Description
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Adult patients will sign the informed consent for the treatment and for processing personal data for research purpose, with their approval for the attendance of the study.
Patients will be given for free a toothpaste with biomimetic hydroxyapatite (Biorepair Enamel-Repair Shock Treatment) and the Investigator will explain the correct procedures for home oral care. The toothpaste will be applied the first 7 days of the month for 9 months with a specific tray.
Teeth will be randomly assigned to:
* Trial group: 1 tooth with MIH from 1 quadrant will be treated with the biomimetic hydroxyapatite toothpaste. The applications will be performed for the first 7 days of the month for 9 months (1 application per day that lasts 10 minutes).
* Control group: 1 contralateral tooth with MIH will not be treated with the biomimetic hydroxyapatite toothpaste Patients will be visited after 1, 2, 3, 6 and 9 months from the baseline. For each visit, BEWE index, Bleeding Index, Gingival index, Plaque index and Dental sensitivity test. Tooth with MIH will be assessed, together with its contralaterals as control. If the contralateral tooth should suffer from MIH too, measurements will be carried out on the adjacent tooth.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Trial Group
Teeth from this group suffer from MIH. They will be evaluated after home oral care with BioRepair toothpaste containing microRepair®.
Biorepair Shock Treatment
Teeth from this group will undergo the application of Biorepair Toothpaste for the first 7 days of the month for 9 months (1 application per day that lasts 10 minutes).
Control Group
Teeth from this group suffer from MIH. They are in the contralateral quadrants in respect to teeth from trial group. They will not be treated with the hydroxyapatite toothpaste.
No treatment
Teeth from this group will not be treated with the experimental toothpaste.
Interventions
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Biorepair Shock Treatment
Teeth from this group will undergo the application of Biorepair Toothpaste for the first 7 days of the month for 9 months (1 application per day that lasts 10 minutes).
No treatment
Teeth from this group will not be treated with the experimental toothpaste.
Eligibility Criteria
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Inclusion Criteria
* good general health (absence of systemic diseases)
Exclusion Criteria
* patients taking drugs
ALL
No
Sponsors
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University of Pavia
OTHER
Responsible Party
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Andrea Scribante
Research Resident, Principal Investigator
Principal Investigators
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Andrea Scribante, DDS, PhD.
Role: PRINCIPAL_INVESTIGATOR
University of Pavia
Locations
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Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, Italy
Countries
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Other Identifiers
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2021-MIH
Identifier Type: -
Identifier Source: org_study_id
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