Biomimetic Hydroxyapatite Toothpaste and Mouthwash for Reducing Dental Sensitivity

NCT07057141 | Completed

• 1 other identifier: 2025-SENSBIOREPAIR
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Tooth Sensitivity; Gingival Recession Generalized Moderate; Gingival Recession Localized Moderate

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Pain Perception Measured by the Visual Analogue Scale (VAS)

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

Study Arms (2)

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.

Device: Biorepair Total Protection Toothpaste

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.

Device: Biorepair High-Density Mouthwash

Interventions

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.

Control Group - Toothpaste

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.

Trial Group - Mouthwash

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Dentin Sensitivity; Gingival Recession

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Periodontal Atrophy

Study Officials

• Andrea Scribante, Associate Professor

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 9, 2025
• Study Start: July 15, 2025
• Primary Completion: September 5, 2025
• Study Completion: September 15, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)