Actively Recruiting
Hydroxyapatite-Based Home Treatment for Dentin Sensitivity in Celiac Patients
Led by University of Pavia · Updated on 2026-04-23
40
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. 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.
CONDITIONS
Official 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 a confirmed diagnosis of 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 scheduled visits
- Providing 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 for 6-month participation
- Currently using treatments that affect enamel mineralization
- Pregnant or breastfeeding
- Participation in another clinical trial within the last 30 days
AI-Screening
AI-Powered Screening
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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
CONTACT
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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