Hydroxyapatite-Based Home Treatment for Dentin Sensitivity in Celiac Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pavia
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Age below 18 years.
Absence of confirmed celiac disease.
Poor compliance or low motivation to participate in a 6-month study.
Ongoing treatment with products affecting enamel mineralization.
Trial design
Design model
Parallel
Treatments tested in this trial
Biorepair Toothpaste and Mousse
DeviceParticipants assigned to the experimental arm will use Biorepair® Total Protection toothpaste twice daily (morning and evening) and apply Biorepair® Plus Intensive Enamel Repair mousse once daily before bedtime, for a total of 6 months. The toothpaste contains microRepair® particles (zinc-substituted hydroxyapatite), designed to occlude dentinal tubules and promote enamel remineralization. The mousse, applied at night, enhances remineralization through higher concentrations of active hydroxyapatite. This combined regimen targets the reduction of dentin hypersensitivity and enamel demineralization in adult patients with celiac disease.
Biorepair® Toothpaste
DeviceParticipants assigned to the control arm will use Biorepair® Total Protection toothpaste twice daily (morning and evening) for 6 months. The toothpaste formulation contains microRepair® (zinc hydroxyapatite) to support daily enamel protection and tubule occlusion, without the adjunctive effect of the mousse. This arm is used to assess the baseline efficacy of the toothpaste alone compared to the combined regimen.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Biorepair Toothpaste + MousseExperimental treatment 1 intervention
Group B: Biorepair Toothpaste OnlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in dentin hypersensitivity assessed by Schiff Air Index
The primary outcome is the variation in dentin hypersensitivity scores measured using the Schiff Air Index at baseline (T0), 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4). The Schiff Air Index is a validated clinical scale ranging from 0 to 3, where higher scores indicate greater sensitivity. The primary analysis will compare the change in scores over time between the experimental group (toothpaste + mousse) and the control group (toothpaste only).
Time frame
Baseline (T0), 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4)Secondary outcomes
1
Change in plaque accumulation assessed by Plaque Index (PI)
Plaque accumulation will be assessed using the Plaque Index (PI) at each time point. The index evaluates four surfaces per tooth and assigns a score from 0 to 3, where 0 indicates no plaque, 1 denotes plaque detectable only with a disclosing agent, 2 represents plaque visible to the naked eye, and 3 corresponds to abundant plaque covering the tooth surface. The average PI score per patient will be calculated and compared between the two groups over time (T0 to T4) to evaluate the impact of the interventions on daily oral hygiene and biofilm control.
Time frame
Assessed at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) from the start of treatment.2
Change in gingival bleeding assessed by Bleeding on Probing (BoP)
Gingival bleeding will be evaluated using the Bleeding on Probing (BoP) index, where gentle probing is performed and bleeding is recorded as either absent (score 0) or present (score 1). The percentage of bleeding sites per participant will be calculated, and reductions in this percentage will indicate improvements in periodontal health.
Time frame
Evaluated at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after treatment initiation.3
Change in self-reported pain using Visual Analogue Scale (VAS)
Dentin hypersensitivity will be self-assessed by participants using a Visual Analogue Scale (VAS), consisting of a 10 cm line anchored at 0 (no pain) and 10 (worst imaginable pain). The score, measured in millimeters from the 0 mark, provides a quantitative measure of pain intensity. Changes in VAS scores over time will be analyzed between groups.
Time frame
Measured at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) from the beginning of the intervention.4
Change in caries experience using DMFT Index
The DMFT index records the total number of Decayed, Missing, and Filled permanent Teeth per individual. Scores range from 0 (no caries experience) up to 28 or 32, depending on the number of teeth present. A reduction or stabilization of DMFT scores over time will indicate an improvement or prevention of caries progression.
Time frame
Assessed at baseline (T0), and at follow-up visits at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4).Sponsors and contacts
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Source ClinicalTrials.gov