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Completed

NCT Number: NCT07057141

Biomimetic Hydroxyapatite Toothpaste and Mouthwash for Reducing Dental Sensitivity

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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Key information

Conditions

Tooth Sensitivity Dentin Sensitivity Gingival Diseases Gingival Recession Gingival Recession Generalized Moderate Gingival Recession Localized Moderate Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, Lombardy, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Dental Sensitivity Measured by the Schiff Air Index

    Time frame: 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 outcomes

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Acronym: SENS-BIOREP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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