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Hydroxyapatite-Based Home Treatment for Dentin Sensitivity in Celiac Patients

RecruitingNAAges 18 Years - anyAllUniversity of Pavia
NCT07069127 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This single-center, randomized controlled clinical trial aims to evaluate the effectiveness of a home-based treatment using hydroxyapatite-based oral care products in adult patients with celiac disease who exhibit enamel demineralization and dentin hypersensitivity. Forty patients will be enrolled and randomly allocated into two parallel groups. The control group will perform home oral hygiene using only a hydroxyapatite-based toothpaste (Biorepair® Total Protection) twice daily. The trial group will follow the same regimen with the toothpaste, but will also apply a hydroxyapatite mousse (Biorepair® Plus Intensive Enamel Repair) once every evening before bedtime throughout the study period. The primary objective is to assess the reduction in dentin hypersensitivity using the Schiff Air Index. Secondary outcomes include changes in plaque accumulation (Plaque Index), gingival bleeding (Bl

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults (≥18 years of age) with a confirmed diagnosis of celiac disease. * Presence of enamel defects (hypomineralization or demineralization). * Presence of active carious lesions. * Self-reported dentin hypersensitivity. * Willingness to comply with the study protocol and follow-up schedule. * Written informed consent provided. Exclusion Criteria: * Age below 18 years. * Absence of confirmed celiac disease. * Poor compliance or low motivation to participate in a 6-month study. * Ongoing treatment with products affecting enamel mineralization. * Pregnancy or breastfeeding. * Participation in another clinical trial within the previous 30 days.
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What it tests

  • Biorepair Toothpaste and Mousse
  • Biorepair® 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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