Biomimetic Hydroxyapatite Toothpaste and Mouthwash for Reducing Dental Sensitivity

Not Applicable

Not yet recruiting

• Conditions: Tooth Sensitivity; Gingival Recession Generalized Moderate; Gingival Recession Localized Moderate

• Registration Number: NCT07057141
• Lead Sponsor: University of Pavia

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-28
• Study First Submitted QC: 2025-06-28
• Last Update Submitted: 2025-06-28
• Study First Posted: 2025-07-09
• Last Update Posted: 2025-07-09
• Study Start: 2025-07-15
• Primary Completion: 2025-09-05
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Dental Sensitivity Measured by the Schiff Air Index	T0 (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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia; 🇮🇹 Pavia, Lombardy, Italy