Hydroxyapatite home treatment for sensitive teeth in people with celiac disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized controlled trial will enroll 40 adults with confirmed celiac disease who have enamel demineralization, active caries, and self-reported dentin hypersensitivity. Participants are randomized into two parallel groups: one using hydroxyapatite toothpaste twice daily, and the other using the same toothpaste plus a nightly hydroxyapatite mousse for the study period. The primary outcome is change in dentin hypersensitivity measured by the Schiff Air Index; secondary outcomes include plaque index, bleeding on probing, pain on a visual analogue scale, and caries experience (DMFT/DMFS). All products are applied at home with scheduled clinic visits at the University of Pavia for baseline and follow-up assessments.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Andrea Scribante, Associate Professor — University of Pavia
• Study coordinator: Andrea Scribante, Associate Professor
• Email: andrea.scribante@unipv.it
• Phone: +39 0382516223

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.