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Hydroxyapatite Toothpastes and Enamel Remineralization:

RecruitingNAAges 6 Years - 18 YearsAllUniversity of Pavia
NCT07069218 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 A

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📋 Eligibility rules (as published)
Inclusion Criteria: * Subjects aged between 6 and 18 years * Ability to understand and follow instructions in Italian or English * Signed written informed consent provided by the parent/legal guardian and assent from the minor * Good cooperation and adherence to clinical instructions * Fully erupted permanent first molars and upper central incisors in good general condition * DIAGNOdent Pen baseline values in the C1 (0-12) or C2 (13-24) range Exclusion Criteria: * DIAGNOdent Pen values greater than 25 * Ongoing systemic antibiotic therapy * Presence of sealants or composite restorations on first permanent molars or upper central incisors * Severe enamel alterations such as molar-incisor hypomineralization (MIH), fluorosis, or extensive white/brown spot lesions * Poor motivation or limited compliance with study procedures
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What it tests

  • Biorepair® Total Protection Plus Toothpaste
  • Bioniq® Toothpaste
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Where

1 site
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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