RECRUITINGINTERVENTIONAL

Hydroxyapatite-Based Home Treatment for Dentin Sensitivity in Celiac Patients

Reduction of Dentin Hypersensitivity and Enamel Demineralization in Patients With Celiac Disease: A Randomized Controlled Trial

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form provided. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DEVICE

Biorepair Toothpaste and Mousse

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.

DEVICE

Biorepair® Toothpaste

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.

Locations (1)

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

Pavia, Lombardy, Italy