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Hydroxyapatite-Based Home Treatment for Dentin Sensitivity in Celiac Patients

Key facts

Who runs it
University of Pavia
Where
Italy1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
40 people, planned
Started
30 Jul 2025
Planned end
10 Sept 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Biorepair Toothpaste and Mousse
  • Biorepair® Toothpaste
Record updated
23 April 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Ongoing treatment with products affecting enamel mineralization
  • Participation in another clinical trial within the previous 30 days
  • Absence of confirmed celiac disease
  • Age below 18 years
  • Poor compliance or low motivation to participate in a 6-month study
  • Pregnancy or breastfeeding

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Biorepair Toothpaste + MousseTreatment being tested

    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: Biorepair Toothpaste and Mousse

  • Biorepair Toothpaste OnlyExisting treatment, for comparison

    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: Biorepair® Toothpaste

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Reduction of Dentin Hypersensitivity and Enamel Demineralization in Patients With Celiac Disease: A Randomized Controlled Trial
Record updated
23 April 2026