Hydroxyapatite-Based Home Treatment for Dentin Sensitivity in Celiac Patients (CELIADENT)

University of Pavia

Status: Enrolling

Conditions: Tooth Demineralization; Celiac Disease; Dentin Hypersensitivity

Treatments: Device: Biorepair® Toothpaste; Device: Biorepair Toothpaste and Mousse

Study type: Interventional

Funder types: Other

Identifiers

NCT07069127

2025-HApCELIAC

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Biorepair Toothpaste + Mousse

Experimental group

Description:

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).

Treatment:

Device: Biorepair Toothpaste and Mousse

Biorepair Toothpaste Only

Active Comparator group

Description:

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.

Treatment:

Device: Biorepair® Toothpaste