Hydroxyapatite-Based Home Treatment for Dentin Sensitivity in Celiac Patients
Key facts
- Who runs it
- University of Pavia
- Where
- Pavia, ItalySee the site
- 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
Where in Italy
- Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of PaviaPavia, ItalyContact: Andrea Scribante, Associate ProfessorTaking people
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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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