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Biomimetic Hydroxyapatite Toothpaste and Mouthwash for Reducing Dental Sensitivity

Effect of Biomimetic Hydroxyapatite-Based Toothpaste and Mouthwash on Dental Sensitivity in Patients With Gingival Recession: A Randomized Controlled Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07057141
Acronym
SENS-BIOREP
Enrollment
100
Registered
2025-07-09
Start date
2025-07-15
Completion date
2025-09-15
Last updated
2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession Generalized Moderate, Gingival Recession Localized Moderate, Tooth Sensitivity

Keywords

Dental Hypersensitivity, Tooth Sensitivity, Gingival Recession, Dentin Hypersensitivity, Hydroxyapatite, Biomimetic Hydroxyapatite, Toothpaste, Mouthwash, Visual Analogue Scale (VAS), Shiff Air Index, Desensitizing Agents, Oral Health

Brief summary

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).

Interventions

DEVICEBiorepair Total Protection Toothpaste

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.

DEVICEBiorepair High-Density Mouthwash

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.

Sponsors

University of Pavia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Male and female subjects aged between 18 and 70; * Subjects with gingival recession and tooth sensitivity; * Subjects who have agreed to give their free written informed consent to participate in the study.

Exclusion criteria

* Male and female subjects who are not adults; * Subjects without gingival recessions; * Subjects without dental sensitivity; * Subjects with poor participation or insufficient motivation to participate in this study.

Design outcomes

Primary

MeasureTime frameDescription
Change in Dental Sensitivity Measured by the Schiff Air IndexT0 (baseline) and T1 (immediately post-treatment, same visit)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.

Secondary

MeasureTime frameDescription
Change in Pain Perception Measured by the Visual Analogue Scale (VAS)T0 (baseline) and T1 (immediately post-treatment, same visit)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).

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026