Hydroxyapatite-Based Home Treatment for Dentin Sensitivity in Celiac Patients

Sponsor
University of Pavia
Study ID
NCT07069127
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biorepair Toothpaste and Mousse — DEVICE
    Participants assigned to the experimental arm will use Biorepair® Total Protection toothpaste twice daily (morning and evening) and apply Biorepair® Plus Intensive Enamel Repair mousse once daily before bedtime, for a total of 6 months. The toothpaste contains microRepair® particles (zinc-substituted hydroxyapatite), designed to occlude dentinal tubules and promote enamel remineralization. The mousse, applied at night, enhances remineralization through higher concentrations of active hydroxyapatite. This combined regimen targets the reduction of dentin hypersensitivity and enamel demineralization in adult patients with celiac disease.
  • Biorepair® Toothpaste — DEVICE
    Participants assigned to the control arm will use Biorepair® Total Protection toothpaste twice daily (morning and evening) for 6 months. The toothpaste formulation contains microRepair® (zinc hydroxyapatite) to support daily enamel protection and tubule occlusion, without the adjunctive effect of the mousse. This arm is used to assess the baseline efficacy of the toothpaste alone compared to the combined regimen.

Study Details

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 (Bleeding on Probing), pain perception (Visual Analogue Scale), and caries experience (DMFT and DMFS indices). Enamel demineralization will be analyzed through near-infrared transillumination (DIAGNOcam), laser fluorescence (DIAGNOdent), and digital image analysis (ImageJ software). All clinical parameters will be evaluated at baseline and after 1 week, 1 month, 3 months, and 6 months. The study seeks to determine whether the addition of a remineralizing mousse to daily oral care provides superior benefits in reducing sensitivity and improving enamel integrity in patients with celiac disease.

Key Dates

Start date
Jul 30, 2025
Status verified
Feb 2026
Primary completion
Jun 1, 2026
Completion
Sep 10, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Biorepair Toothpaste + Mousse
    Participants in this group will perform home oral hygiene using Biorepair® Total Protection toothpaste twice daily and apply Biorepair® Plus Intensive Enamel Repair mousse once every evening before bedtime for the duration of the study (6 months).
  • Active Comparator: Biorepair Toothpaste Only
    Participants in this group will perform home oral hygiene using Biorepair® Total Protection toothpaste twice daily, without the use of the additional mousse. This regimen will continue for the entire 6-month study period.

Primary Outcome Measure

Change in dentin hypersensitivity assessed by Schiff Air Index [ Time Frame: Baseline (T0), 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) ]

Central Contacts

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