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To evaluate the efficacy of enamel remineralization by biomimetic hydroxyapatite contained in microRepair-based Biorepair Total Protection toothpaste compared to the use of Bio Enamel Caries and Erosion toothpaste based on Fluoro-Hydroxyapatite and BioActive Complex, evaluated with Diagnodent Pen and Diagnocam.
The recruited patients will be divided into:
Group 1: Active group 20 patients undergoing quarterly oral hygiene sessions and home treatment using Biorepair Total Protection toothpaste 2 times/day
Gruppo 2: Active group 20 patients undergoing quarterly oral hygiene sessions and home treatment using Curasept Biosmalto Caries and Erosion toothpaste 2 times/day
For both groups, Diagnodent Pen will be used to evaluate the degree of demineralization, while Diagnocam will be used as qualitative evaluation.
Other clinical indices to be collected are: plaque index (PI), bleeding index (BOP), basic erosive wear examination (BEWE), Schiff Air Index (SAI).
The time frames of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biorepair Total protection toothpaste | Experimental |
| |
| Biosmalto Caries and Erosion | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home use | Other | Home use twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diagnodent Pen value | Scores (according to the manufacturer): 0 - 12: Normal prophylaxis (such as fluoride toothpaste) 13 - 24: Intensive prophylaxis (e.g. fluoridation, remineralisation) > 25: Minimally invasive restorative procedures, composite filling materials and intensive prophylaxis (e.g. remineralisation, Air Abrasion, SONICflex micro), conventional restoration with large lesions, depending on risk assessment and findings. | Study begin, 1, 3 and 6 months after the baseline |
| Change in Diagnocam value | Qualitative evaluation. | Study begin, 1, 3 and 6 months after the baseline |
| Change in Schiff Air Index | 0: the subject did not respond to air blasting;
| Study begin, 1, 3 and 6 months after the baseline |
| Change in Bleeding on Probing | Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites. Percentage of sites with bleeding on probing determines the BOP%. | Study begin, 1, 3 and 6 months after the baseline |
| Change in Plaque Index | Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces. Formula = n ° sites with plaque / total n ° of dental surfaces x100 | Study begin, 1, 3 and 6 months after the baseline |
| Change in Basic Erosive Wear Examination |
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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 the Principal Investigator.
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Scoring criteria (Barlet et al., 2008): 0: no erosive tooth wear;
|
| Study begin, 1, 3 and 6 months after the baseline |