Hydroxyapatite-Based Home Treatment for Dentin Sensitivity in Celiac Patients

NCT07069127 | Recruiting

• 1 other identifier: 2025-HApCELIAC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Celiac Disease; Dentin Hypersensitivity; Tooth Demineralization

Keywords

Celiac Disease; Dentin Hypersensitivity; Enamel Demineralization; Hydroxyapatite; Remineralizing Agents; Biorepair; Toothpaste; Oral Mousse; Dental Sensitivity; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change in dentin hypersensitivity assessed by Schiff Air Index

  The primary outcome is the variation in dentin hypersensitivity scores measured using the Schiff Air Index at baseline (T0), 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4). The Schiff Air Index is a validated clinical scale ranging from 0 to 3, where higher scores indicate greater sensitivity. The primary analysis will compare the change in scores over time between the experimental group (toothpaste + mousse) and the control group (toothpaste only).

  Baseline (T0), 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4)

Secondary Outcomes (7)

• Change in plaque accumulation assessed by Plaque Index (PI)

  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)

  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)

  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

  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

  Recorded at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after enrollment.

Study Arms (2)

Biorepair Toothpaste + Mousse

EXPERIMENTAL

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).

Device: Biorepair Toothpaste and Mousse

Biorepair Toothpaste Only

ACTIVE COMPARATOR

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.

Device: Biorepair® Toothpaste

Interventions

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.

Biorepair Toothpaste Only

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 + Mousse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Celiac Disease; Dentin Sensitivity; Tooth Demineralization

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Andrea Scribante, Associate Professor

  University of Pavia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Scribante, Associate Professor

CONTACT

+39 0382516223; andrea.scribante@unipv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 16, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)