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Hydroxyapatite-Based Home Treatment for Dentin Sensitivity in Celiac Patients

Study acronym: CELIADENT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 23, 2026 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study completion pushed from Jun 10, 2026 to Sep 10, 2026v4
  2. Minor Primary completion date: Jan 30, 2026 to Jun 1, 2026
    • Study completion date: Feb 15, 2026 to Jun 10, 2026
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07069127
Lead Sponsor University of Pavia
Conditions
(from sponsor)
Celiac Disease, Dentin Hypersensitivity, Tooth Demineralization
Related terms Celiac Disease, Dentin Sensitivity, Tooth Demineralization
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov