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Hydroxyapatite Toothpastes and Enamel Remineralization:

NCT07069218 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-20

No results posted yet for this study

Summary

This randomized controlled clinical trial aims to evaluate the efficacy of two commercially available toothpastes containing hydroxyapatite in the remineralization of early enamel lesions. The study compares Biorepair® Total Protection Plus, which contains biomimetic microRepair particles, with Bioniq® Repair, a conventional hydroxyapatite-based toothpaste.

Forty participants will be randomly assigned to either the trial group (Biorepair®) or the control group (Bioniq®), and both groups will receive quarterly professional dental cleanings and use the assigned toothpaste twice daily for 6 months.

The primary outcome is the change in enamel demineralization, assessed by DIAGNOdent Pen scores, in permanent molar fissures and upper central incisors. Secondary outcomes include enamel integrity assessed by DIAGNOcam imaging and ICDAS scores, as well as changes in dental sensitivity (Schiff Air Index), erosive wear (BEWE Index), plaque accumulation (Plaque Index), gingival inflammation (Bleeding Index), and extrinsic stains (Modified Lobene Stain Index). Patient satisfaction will also be evaluated at the end of the study using a self-administered questionnaire.

This study will help determine whether biomimetic hydroxyapatite offers superior benefits in maintaining enamel health compared to conventional formulations, supporting evidence-based preventive strategies in dental care.

Conditions

  • Enamel Hypomineralization
  • Tooth Erosion

Interventions

DRUG

Biorepair® Total Protection Plus Toothpaste

Participants will use Biorepair® Total Protection Plus toothpaste twice daily for 6 months. The toothpaste contains biomimetic microRepair® particles based on zinc-substituted hydroxyapatite, intended to promote enamel remineralization, reduce sensitivity, and protect against erosion and plaque accumulation. Professional dental cleanings will also be performed every 3 months.

DRUG

Bioniq® Toothpaste

Participants will use Bioniq® Repair toothpaste twice daily for 6 months. The toothpaste contains 20% conventional hydroxyapatite and is designed to restore enamel, reduce dentin hypersensitivity, and protect against erosion. Professional dental cleanings will also be performed every 3 months.

Sponsors & Collaborators

  • University of Pavia

    lead OTHER

Principal Investigators

  • Andrea Scribante, Associate Professor · University of Pavia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-25
Primary Completion
2026-06-01
Completion
2026-06-10

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07069218 on ClinicalTrials.gov