Biomimetic Hydroxyapatite Toothpaste and Mouthwash for Reducing Dental Sensitivity (SENS-BIOREP)

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

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).

Study Overview

• Status: Completed
• Conditions: Tooth Sensitivity; Gingival Recession Generalized Moderate; Gingival Recession Localized Moderate
• Intervention / Treatment: Device: Biorepair Total Protection Toothpaste; Device: Biorepair High-Density Mouthwash

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group - Toothpaste; 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.	Device: Biorepair 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.
Experimental: Trial Group - Mouthwash; 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.	Device: Biorepair 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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).	T0 (baseline) and T1 (immediately post-treatment, same visit)

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Principal Investigator: Andrea Scribante, Associate Professor, University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2025
• Primary Completion (Actual): September 5, 2025
• Study Completion (Actual): September 15, 2025

Study Registration Dates

• First Submitted: June 28, 2025
• First Submitted That Met QC Criteria: June 28, 2025
• First Posted (Actual): July 9, 2025

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Oral Health; Tooth Sensitivity; Gingival Recession; Hydroxyapatite; Mouthwash; Toothpaste; Dentin Hypersensitivity; Visual Analogue Scale (VAS); Dental Hypersensitivity; Biomimetic Hydroxyapatite; Shiff Air Index; Desensitizing Agents
• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Gingival Diseases; Dentin Sensitivity; Gingival Recession
• Other Study ID Numbers: 2025-SENSBIOREPAIR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available upon motivated request to the corresponding authors.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No