Celiac DiseaseCELIADENTNCT07069127
Hydroxyapatite-Based Home Treatment for Dentin Sensitivity in Celiac Patients
A study testing Biorepair Toothpaste and Mousse and Biorepair® Toothpaste in people with Celiac Disease and Dentin Hypersensitivity, run by University of Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Celiac Disease, Dentin Hypersensitivity, Tooth Demineralization
- What is being tested?
- Biorepair Toothpaste and Mousse and Biorepair® Toothpaste
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jul 2025to 10 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Pregnancy or breastfeeding.
- Participation in another clinical trial within the previous 30 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
Andrea Scribante, Associate Professor, +39 0382516223, andrea.scribante@unipv.it
About this study
Official title: Reduction of Dentin Hypersensitivity and Enamel Demineralization in Patients With Celiac Disease: A Randomized Controlled 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.
- Being tested
- Biorepair Toothpaste and Mousse, Biorepair® Toothpaste
- Keywords
- Celiac Disease, Dentin Hypersensitivity, Enamel Demineralization, Hydroxyapatite, Remineralizing Agents, Biorepair, Toothpaste, Oral Mousse, Dental Sensitivity, Randomized Controlled Trial
- Medical subject headings
- Celiac Disease, Dentin Sensitivity, Tooth Demineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biorepair Toothpaste and MousseDevice
Participants 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® ToothpasteDevice
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| Biorepair Toothpaste + Mousse | Experimental | 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). Receives: Device: Biorepair Toothpaste and Mousse |
| Biorepair Toothpaste Only | Active comparator | 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. Receives: Device: Biorepair® Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (T0), 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4)
Secondary outcomes (7)
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.
Measured: Assessed at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) from the start of treatment.
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.
Measured: Evaluated at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after treatment initiation.
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.
Measured: 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.
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.
Measured: Assessed at baseline (T0), and at follow-up visits at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4).
Change in caries experience using DMFS Index
The DMFS index expands the DMFT to include all tooth surfaces, providing a more sensitive measure of caries experience. Each surface is assessed individually, and scores range from 0 (no affected surfaces) to a maximum depending on the total number of tooth surfaces. Higher values indicate more extensive caries. Scores will be compared across time points between groups.
Measured: Recorded at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after enrollment.
Change in enamel lesion area assessed by DIAGNOcam and ImageJ software
The extent of enamel demineralization will be assessed using near-infrared light transillumination with the DIAGNOcam device. The captured images will be processed using ImageJ software to quantify the surface area of enamel lesions in square millimeters. Each lesion will be manually outlined and analyzed by a calibrated examiner. The score assigned will represent the total area (in mm²) of demineralized enamel per tooth. Higher values indicate greater lesion extension. A progressive reduction in lesion surface area over time will be interpreted as a sign of remineralization. Intergroup comparisons will assess the impact of the hydroxyapatite-based intervention on enamel integrity.
Measured: Evaluated at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) from treatment initiation.
Change in enamel fluorescence using DIAGNOdent
Enamel demineralization will be measured using the DIAGNOdent pen, which emits a low-power laser and detects fluorescence from porous enamel. Each site will receive a numerical score ranging from 0 to 99, where 0-10 indicates sound enamel, 11-20 indicates initial demineralization, 21-30 suggests moderate demineralization, and scores above 30 reflect advanced mineral loss. For each lesion, the highest DIAGNOdent value will be recorded, and the average value per participant will be calculated. A reduction in fluorescence values across time points will indicate enamel remineralization and clinical improvement.
Measured: Obtained at baseline (T0), and at follow-up evaluations at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) following the start of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start30 Jul 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, Associate Professor, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069127
- Sponsor's protocol ID
- 2025-HApCELIAC
- Acronym
- CELIADENT
- Status last verified
- Feb 2026
- First submitted
- 5 Jul 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the corresponding authors.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Dentin Hypersensitivity and Enamel Demineralization in Patients With Celiac Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07069127
- Acronym / sponsor ID
- CELIADENT / 2025-HApCELIAC
- Keywords
- Celiac Disease, Dentin Hypersensitivity, Enamel Demineralization, Hydroxyapatite, Remineralizing Agents, Biorepair, Toothpaste, Oral Mousse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biorepair Toothpaste + Mousse | Experimental | Device: Biorepair Toothpaste and MousseParticipants 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). |
| Biorepair Toothpaste Only | Active comparator | Device: Biorepair® ToothpasteParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biorepair Toothpaste and MousseParticipants 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. | Device | Biorepair Toothpaste + Mousse |
| Biorepair® ToothpasteParticipants 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. | Device | Biorepair Toothpaste Only |
Primary outcome
Change in dentin hypersensitivity assessed by Schiff Air Index
Time frame: Baseline (T0), 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4)
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).
7 secondary outcomes
Change in plaque accumulation assessed by Plaque Index (PI)
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.
Change in gingival bleeding assessed by Bleeding on Probing (BoP)
Time frame: Evaluated at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after treatment initiation.
Change in self-reported pain using Visual Analogue Scale (VAS)
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.
Change in caries experience using DMFT Index
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).
Change in caries experience using DMFS Index
Time frame: Recorded at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) after enrollment.
Change in enamel lesion area assessed by DIAGNOcam and ImageJ software
Time frame: Evaluated at baseline (T0), and at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) from treatment initiation.
Change in enamel fluorescence using DIAGNOdent
Time frame: Obtained at baseline (T0), and at follow-up evaluations at 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4) following the start of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the corresponding authors.
Related trials for Celiac Disease
RecruitingObservational study
Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
Celiac Disease, Gluten-free Diet
Active, not recruitingEarly Phase 1
VTP-1000 in Adults With Celiac Disease
Celiac Disease
Recruiting
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Celiac Disease in Children, Nutrition Disorder, Child
RecruitingObservational study
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
Celiac Disease
RecruitingObservational study
Pathogenic Study of Adult Immune Enteropathies
Celiac Disease, Autoimmune Enteropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Scribante, Associate Professor principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biorepair Toothpaste and Mousse and Biorepair® Toothpaste in people with Celiac Disease and Dentin Hypersensitivity, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Scribante, Associate Professor (+39 0382516223, andrea.scribante@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dentin hypersensitivity assessed by Schiff Air Index (time frame: Baseline (T0), 1 week (T1), 1 month (T2), 3 months (T3), and 6 months (T4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.