Hydroxyapatite-Based Home Treatment for Dentin Sensitivity in Celiac Patients

Official title

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

Overview

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.

Interventions

• 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 hydroxyapat
• 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.

Primary outcome measures

• 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)]

Secondary outcome measures (7)

• Change in plaque accumulation assessed by Plaque Index (PI) [Time frame: Assessed at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) from the start of treatment.]
• Change in gingival bleeding assessed by Bleeding on Probing (BoP) [Time frame: Evaluated at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after treatment initiation.]
• Change in self-reported pain using Visual Analogue Scale (VAS) [Time frame: Measured at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) from the beginning of the intervention.]
• Change in caries experience using DMFT Index [Time frame: Assessed at baseline (T0), and at follow-up visits at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4).]
• Change in caries experience using DMFS Index [Time frame: Recorded at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after enrollment.]
• Change in enamel lesion area assessed by DIAGNOcam and ImageJ software [Time frame: Evaluated at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) from treatment initiation.]
• Change in enamel fluorescence using DIAGNOdent [Time frame: Obtained at baseline (T0), and at follow-up evaluations at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) following the start of treatment.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 1 center

• Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinic — Pavia

Identifiers

NCT: NCT07069127 · 2025-HApCELIAC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗