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The aim of the following study is to evaluate che clinical efficacy of a toothpaste with biomimetic hydroxyapatite for the management of Molar-Incisor Hypomineralization. Patients who agree to participate to the study will use Biorepair toothpaste for the first 7 days of the month for 3, 6 and 9 months. The following indices will be measured: BEWE, Bleeding Index, Gingival index, Plaque index and the dental sensitivity test. The contralateral tooth will be used as control if not affected by MIH; otherwise, adjacent teeth will be considered.
Informed consent will be signed by the parents of the patients underage; patients will be asked the approval for the attendance of the study.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial Group | Experimental | Teeth from this group suffer from MIH. They will be evaluated after home oral care with BioRepair toothpaste containing microRepair®. |
|
| Control Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biorepair Shock Treatment | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change of BI - Bleeding Index | Scoring criteria:
| Study begin, 1,2,3, 6 and 9 months |
| Change of GI - Gingival Index (Loe and Silness, 1963) | Scoring criteria:
| Study begin, 1,2,3, 6 and 9 months |
| Change of PCR - Plaque Control Record (O'Leary, 1972) | 4 surfaces scored (mesial, distal, vestibular, labial/palatal) per tooth by means of plaque relevator. The Index is calculated multiplying the total number of surfaces with plaque per 100. | Study begin, 1,2,3, 6 and 9 months |
| Change in Schiff Air Index - Dental sensitivity test | Scoring criteria: 0. the subject did not respond to air blasting;
| Study begin, 1,2,3, 6 and 9 months |
| Change of BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008) | Scoring criteria:
Additionally, risk level for clinical management will be assessed. | Study begin, 1,2,3, 6 and 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Scribante, DDS, PhD. | University of Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia | Pavia | Lombardy | 27100 | Italy |
Data will be available upon motivated request to Principal Investigator
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| ID | Term |
|---|---|
| D000094604 | Molar Hypomineralization |
| ID | Term |
|---|---|
| D000094603 | Dental Enamel Hypomineralization |
| D000094602 | Developmental Defects of Enamel |
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
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| No treatment | Other | Teeth from this group will not be treated with the experimental toothpaste. |
|
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |