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This randomized controlled clinical trial evaluates the effectiveness of a biomimetic hydroxyapatite-based toothpaste and mouthwash in reducing dental sensitivity in patients with gingival recession. A total of 100 participants will be randomly assigned to two groups. The control group will receive Biorepair Total Protection toothpaste, and the trial group will receive Biorepair high-density mouthwash. Both products will be applied for 30 seconds. Dental sensitivity will be assessed before and after treatment using the Shiff Air Index and the Visual Analogue Scale (VAS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group - Toothpaste | Active Comparator | 50 participants will receive a single 30-second application of Biorepair Total Protection toothpaste. The intervention aims to reduce dental sensitivity in patients with gingival recession. Clinical indices (Schiff Air Index and VAS) will be assessed before and after application. |
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| Trial Group - Mouthwash | Experimental | 50 participants will receive a single 30-second application of Biorepair high-density mouthwash. The intervention aims to reduce dental sensitivity in patients with gingival recession. Clinical indices (Schiff Air Index and VAS) will be assessed before and after application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biorepair Total Protection Toothpaste | Device | Application of Biorepair Total Protection toothpaste for 30 seconds, performed once in a clinical setting. The aim is to reduce dental sensitivity in patients with gingival recession. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dental Sensitivity Measured by the Schiff Air Index | Variation in dental sensitivity scores assessed using the Schiff Air Index at baseline (T0) and after a 30-second application of either toothpaste or mouthwash (T1). The Schiff scale ranges from 0 (no response) to 3 (painful response to air stimulus), with higher scores indicating greater sensitivity. | T0 (baseline) and T1 (immediately post-treatment, same visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Perception Measured by the Visual Analogue Scale (VAS) | Variation in perceived pain intensity related to dental sensitivity, reported by the patient using the Visual Analogue Scale (VAS) at two timepoints: T0 (baseline) and T1 (immediately after 30-second treatment with either toothpaste or mouthwash). The VAS is a 10 cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Scribante, Associate Professor | University of Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia | Pavia | Lombardy | 27100 | Italy |
Data will be available upon motivated request to the corresponding authors.
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
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| Biorepair High-Density Mouthwash | Device | Application of Biorepair High-Density mouthwash for 30 seconds, performed once in a clinical setting. The aim is to reduce dental sensitivity in patients with gingival recession. |
|
| T0 (baseline) and T1 (immediately post-treatment, same visit) |
| D009059 |
| Mouth Diseases |
| D055093 | Periodontal Atrophy |