Hydroxyapatite home treatment for sensitive teeth in people with celiac disease
Reduction of Dentin Hypersensitivity and Enamel Demineralization in Patients With Celiac Disease: A Randomized Controlled Trial
The trial will see if adding a nightly hydroxyapatite mousse to regular hydroxyapatite toothpaste reduces tooth sensitivity in adults with celiac disease and enamel demineralization.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pavia Academic / other |
| Locations | 1 site (Pavia, Lombardy) |
| Trial ID | NCT07069127 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (18+) with a confirmed diagnosis of celiac disease who have enamel hypomineralization or demineralization, active carious lesions, and self-reported dentin hypersensitivity who can comply with a six-month home regimen are ideal candidates.
Not a fit: People without confirmed celiac disease, without enamel defects or dentin hypersensitivity, those currently using other remineralizing treatments, pregnant or breastfeeding individuals, or those unable to comply with follow-up are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the regimen could reduce tooth sensitivity and support enamel remineralization in adults with celiac-related enamel defects.
How similar studies have performed: Hydroxyapatite-based oral products have shown efficacy in reducing sensitivity and aiding remineralization in prior studies, but use specifically targeted to celiac-associated enamel defects is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pavia, Lombardy
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.