Reduction of Dentin Hypersensitivity and Enamel Demineralization in Patients With Celiac Disease: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
RECRUITING
Pavia
Contact Information
Primary
Andrea Scribante, Associate Professor
andrea.scribante@unipv.it
+39 0382516223
Time Frame
Start Date: 2025-07-30
Estimated Completion Date: 2026-02-15
Participants
Target number of participants: 40
Treatments
Experimental: Biorepair Toothpaste + Mousse
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).
Active_comparator: Biorepair Toothpaste Only
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.
Related Therapeutic Areas
Sponsors
Leads: University of Pavia

This content was sourced from clinicaltrials.gov