Actively Recruiting
Reduction of Dentin Hypersensitivity and Enamel Demineralization in Patients With Celiac Disease: A Randomized Controlled Trial
Led by University of Pavia · Updated on 2026-04-23
40
Participants Needed
1
Research Sites
14 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of hydroxyapatite-based oral care products to reduce dentin hypersensitivity and improve enamel health in adults with celiac disease who have enamel demineralization and dentin sensitivity. This randomized controlled clinical trial will include 40 patients divided into two groups to compare the effects of toothpaste alone versus toothpaste combined with a remineralizing mousse. One group will use a hydroxyapatite-based toothpaste twice daily and apply a hydroxyapatite mousse every evening before bed for six months. The other group will only use the toothpaste twice daily for the same period. The toothpaste contains microRepair particles designed to protect enamel and reduce sensitivity, while the mousse provides additional remineralization support. Participants will be assessed at the start and after 1 week, 1 month, 3 months, and 6 months. Evaluations include dentin hypersensitivity using the Schiff Air Index, plaque buildup, gum bleeding, pain levels, caries experience, and enamel condition assessed with special imaging and fluorescence tools. The study aims to determine if adding the mousse offers better protection and sensitivity reduction in this population.
CONDITIONS
Brief Title
Hydroxyapatite-Based Home Treatment for Dentin Sensitivity in Celiac Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (18 years of age or older) with confirmed celiac disease
- Presence of enamel defects such as hypomineralization or demineralization
- Presence of active carious lesions
- Self-reported dentin hypersensitivity
- Willingness to follow the study protocol and attend follow-up visits
- Provided written informed consent
You will not qualify if you...
- Under 18 years of age
- No confirmed diagnosis of celiac disease
- Poor compliance or low motivation to participate for 6 months
- Currently using products that affect enamel mineralization
- Pregnant or breastfeeding
- Participated in another clinical trial within the past 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants perform home oral hygiene using Biorepair® Total Protection toothpaste twice daily for 6 months. Participants in the experimental group also apply Biorepair® Plus Intensive Enamel Repair mousse once every evening before bedtime. This treatment aims to reduce dentin hypersensitivity and enamel demineralization.
5 visits (baseline, 1 week, 1 month, 3 months, and 6 months)
Trial Site Locations
Total: 1 location
1
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, Italy, 27100
Actively Recruiting
Research Team
A
Andrea Scribante, Associate Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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