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The aim of this study is to evaluate the quantity of Biorepair Total Protection toothpaste on composite surfaces inside oral cavity. Three orthodontic lingual buttons are bonded on the vestibular surfaces of upper right premolars (1.4 and 1.5) and upper right first molars (1.6) of volunteers. A composite resine is applied upon them. Then, after 7 days, 1.4 button will be debonded; after 15 days, 1.5 button are debonded; in the end, after 30 days the last button (1.6) is debonded. The buttons will be stored in sterile environment and then sent to laboratory for SEM evaluation.
Orthodontic buttons are bonded on the vestibular surfaces of the upper right premolars (1.4 and 1.5) and the upper right first molar (1.6). A composite resin is polymerized on the top of the buttons. Then, participants are divided into two groups.
After 7 days from the procedure of bonding, the buttons on upper right first premolars (1.4) are debonded. After 15 days from the procedure of bonding, the buttons on upper right second premolars (1.5) are debonded. In the end, After 30 days from the procedure of bonding, the buttons on upper right first molars (1.6) are debonded.
Debonded buttons are then stored in sterile environment at 2-3°C temperature; successively, they are sent to laboratory for SEM evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial Group | Active Comparator | Volunteers from this group will have bonded buttons on vestibular surfaces of elements 1.4, 1.5 and 1.6. Then they will use Biorepair Total Protection for home oral care for 30 days. In this time period, the buttons will be respectively debonded at 7 (1.4), 15 (1.5) and 30 (1.6) days after the bonding procedures, in order to be evaluated at SEM. |
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| Control Group | Active Comparator | Volunteers from this group will have bonded buttons on vestibular surfaces of elements 1.4, 1.5 and 1.6. Then they will use Sensodyne Repair & Protect for home oral care for 30 days. In this time period, the buttons will be respectively debonded at 7 (1.4), 15 (1.5) and 30 (1.6) days after the bonding procedures, in order to be evaluated at SEM. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biorepair Total Protection | Other | Volunteers will use Biorepair Total Protection for home oral hygiene for the following 30 days from the bonding procedure. |
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| Measure | Description | Time Frame |
|---|---|---|
| % microRepair® on composite surfaces | SEM evaluation of the percentage of microRepair® on composite surfaces. | 7 days from the bonding procedure. |
| % microRepair® on composite surfaces | SEM evaluation of the percentage of microRepair® on composite surfaces. | 15 days from the bonding procedure. |
| % microRepair® on composite surfaces | SEM evaluation of the percentage of microRepair® on composite surfaces. | 30 days from the bonding procedure. |
| Comparison with Control Group | SEM evaluation of the possibile differences between Trial and Control Groups. | 7 days from the bonding procedure. |
| Comparison with Control Group | SEM evaluation of the possibile differences between Trial and Control Groups. | 15 days from the bonding procedure. |
| Comparison with Control Group | SEM evaluation of the possibile differences between Trial and Control Groups. | 30 days from the bonding procedure. |
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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 |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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Volunteers will have buttons bonded on the vestibular surfaces of elements 1.4,1.5,1.6. Then, they will be randomly divided into two groups: Trial Group will use Biorepair Total Protection toothpaste for home oral care, whereas Control Group will use Sensodyne Repair & Protect for home oral care.
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| Sensodyne Repair & Protect | Other | Volunteers will use Sensodyne Repair & Protect for home oral hygiene for the following 30 days from the bonding procedure. |
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