Enamel HypomineralizationHEREMINCT07069218
Hydroxyapatite Toothpastes and Enamel Remineralization:
A study testing Biorepair® Total Protection Plus Toothpaste and Bioniq® Toothpaste in people with Enamel Hypomineralization and Tooth Erosion, run by University of Pavia at 1 site in Italy.
Trial summary
This randomized controlled clinical trial aims to evaluate the efficacy of two commercially available toothpastes containing hydroxyapatite in the remineralization of early enamel lesions. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Enamel Hypomineralization, Tooth Erosion
- What is being tested?
- Biorepair® Total Protection Plus Toothpaste and Bioniq® Toothpaste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jul 2025to 10 Jun 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects aged between 6 and 18 years
- Ability to understand and follow instructions in Italian or English
- Signed written informed consent provided by the parent/legal guardian and assent from the minor
- Good cooperation and adherence to clinical instructions
- Fully erupted permanent first molars and upper central incisors in good general condition
- DIAGNOdent Pen baseline values in the C1 (0-12) or C2 (13-24) range
Who cannot join
- DIAGNOdent Pen values greater than 25
- Ongoing systemic antibiotic therapy
- Presence of sealants or composite restorations on first permanent molars or upper central incisors
- Severe enamel alterations such as molar-incisor hypomineralization (MIH), fluorosis, or extensive white/brown spot lesions
- Poor motivation or limited compliance with study procedures
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: Efficacy of Two Hydroxyapatite-Based Toothpastes on Enamel Remineralization: A Randomized Controlled Trial
This randomized controlled clinical trial aims to evaluate the efficacy of two commercially available toothpastes containing hydroxyapatite in the remineralization of early enamel lesions. The study compares Biorepair® Total Protection Plus, which contains biomimetic microRepair particles, with Bioniq® Repair, a conventional hydroxyapatite-based toothpaste.
Forty participants will be randomly assigned to either the trial group (Biorepair®) or the control group (Bioniq®), and both groups will receive quarterly professional dental cleanings and use the assigned toothpaste twice daily for 6 months.
Read more
The primary outcome is the change in enamel demineralization, assessed by DIAGNOdent Pen scores, in permanent molar fissures and upper central incisors. Secondary outcomes include enamel integrity assessed by DIAGNOcam imaging and ICDAS scores, as well as changes in dental sensitivity (Schiff Air Index), erosive wear (BEWE Index), plaque accumulation (Plaque Index), gingival inflammation (Bleeding Index), and extrinsic stains (Modified Lobene Stain Index). Patient satisfaction will also be evaluated at the end of the study using a self-administered questionnaire.
This study will help determine whether biomimetic hydroxyapatite offers superior benefits in maintaining enamel health compared to conventional formulations, supporting evidence-based preventive strategies in dental care.
- Conditions
- Enamel Hypomineralization, Tooth Erosion
- Being tested
- Biorepair® Total Protection Plus Toothpaste, Bioniq® Toothpaste
- Keywords
- Hydroxyapatite Toothpaste, Enamel Remineralization, DIAGNOcam, DIAGNOdent, Tooth Erosion, Dentin Sensitivity, Dental Plaque, Oral Health, Randomized Controlled Trial, Preventive Dentistry
- Medical subject headings
- Dental Enamel Hypomineralization, Tooth Erosion, Dentin Sensitivity, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biorepair® Total Protection Plus ToothpasteDrug
Participants will use Biorepair® Total Protection Plus toothpaste twice daily for 6 months. The toothpaste contains biomimetic microRepair® particles based on zinc-substituted hydroxyapatite, intended to promote enamel remineralization, reduce sensitivity, and protect against erosion and plaque accumulation. Professional dental cleanings will also be performed every 3 months.
Bioniq® ToothpasteDrug
Participants will use Bioniq® Repair toothpaste twice daily for 6 months. The toothpaste contains 20% conventional hydroxyapatite and is designed to restore enamel, reduce dentin hypersensitivity, and protect against erosion. Professional dental cleanings will also be performed every 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Biorepair Group | Experimental | Participants receive professional oral hygiene sessions every 3 months and use Biorepair® Total Protection Plus toothpaste (biomimetic microRepair-based) twice daily for 6 months. Receives: Drug: Biorepair® Total Protection Plus Toothpaste |
| Bioniq Group | Active comparator | Participants receive professional oral hygiene sessions every 3 months and use Bioniq® Repair toothpaste (conventional hydroxyapatite-based) twice daily for 6 months. Receives: Drug: Bioniq® Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DIAGNOdent Pen values in enamel fissures and upper central incisors
- assess the remineralizing efficacy of biomimetic hydroxyapatite (Biorepair® Total Protection Plus) compared to conventional hydroxyapatite (Bioniq® Repair) by evaluating the reduction in DIAGNOdent Pen fluorescence values recorded in the occlusal fissures of permanent molars and on the surfaces of upper central incisors. Measurements will be taken at four timepoints (T0, T1, T2, T3) over a 6-month period.
The DIAGNOdent Pen provides a numerical score (0-99) based on laser fluorescence, where higher values indicate increased enamel demineralization. Lower values after treatment reflect improved enamel health and remineralization.
Measured: Baseline to 6 months (T0-T3)
Secondary outcomes (7)
Change in ICDAS Scores via DIAGNOcam Imaging
To assess enamel demineralization using the International Caries Detection and Assessment System (ICDAS) recorded through DIAGNOcam transillumination images. The PI will assign ICDAS scores to the occlusal surfaces of permanent molars and labial surfaces of upper central incisors at each timepoint. The ICDAS scoring system ranges from 0 to 6, where a score of 0 indicates sound tooth structure, scores of 1 and 2 represent initial changes in enamel, and scores from 3 to 6 reflect progressive levels of localized enamel breakdown and cavitation. A decrease in score over time is interpreted as a sign of remineralization or lesion arrest.
Measured: Baseline to 6 months (T0-T3)
Change in Dentin Hypersensitivity Using Schiff Air Index
To evaluate dentin hypersensitivity in response to an air stimulus applied to exposed cervical surfaces using the Schiff Air Index. The clinician will assign a score from 0 to 3, where a score of 0 indicates no reaction, 1 indicates a reaction without the patient requesting discontinuation, 2 indicates a reaction and a request to stop, and 3 indicates a strong reaction and immediate request to discontinue. The score reflects the participant's response to air-blast stimulation and will be recorded at each timepoint. A decrease in score suggests reduced hypersensitivity.
Measured: Baseline to 6 months (T0-T3)
Change in Enamel Erosion Using BEWE Index
To monitor changes in enamel erosion using the Basic Erosive Wear Examination (BEWE) index. The examiner will assess each sextant and assign a score from 0 to 3. A score of 0 indicates no erosive tooth wear, a score of 1 indicates initial surface loss, a score of 2 represents distinct defects with hard tissue loss involving less than 50% of the surface area, and a score of 3 indicates hard tissue loss affecting more than 50% of the surface. The highest score per sextant is recorded, and a cumulative BEWE score is calculated for each participant at every timepoint. A reduction in the BEWE score suggests improved enamel preservation.
Measured: Baseline to 6 months (T0-T3)
Change in Plaque Accumulation Using Plaque Index
To evaluate changes in plaque accumulation between groups using the Plaque Index (Silness and Löe, 1964), which measures plaque thickness along the gingival margin. The scoring system ranges from 0 to 3. A score of 0 indicates no plaque. A score of 1 corresponds to a thin film of plaque adhering to the free gingival margin and adjacent area of the tooth, which is only detectable by running a probe across the tooth surface. A score of 2 represents moderate accumulation of soft deposits visible to the naked eye, either on the tooth surface or within the gingival margin. A score of 3 indicates heavy accumulation of soft debris in the gingival pocket or on the tooth and gingival margin. The PI assigns a score for each examined surface, and the average value per participant is calculated at each timepoint (T0-T3).
Measured: Baseline to 6 months (T0-T3)
Change in Gingival Inflammation Using Bleeding Index
To assess changes in gingival inflammation by comparing Bleeding Index (BI) values between groups at each study timepoint. The clinician will gently probe the gingival sulcus of selected teeth and assign a score from 0 to 3 for each site. A score of 0 indicates no bleeding after probing. A score of 1 indicates isolated bleeding spots visible after probing. A score of 2 indicates a line of blood along the gingival margin. A score of 3 indicates profuse bleeding immediately after probing. The average score per participant will be calculated based on all examined sites at each timepoint. Higher scores reflect greater gingival inflammation.
Measured: Baseline to 6 months (T0-T3)
Change in Extrinsic Staining Using Modified Lobene Stain Index
To evaluate changes in extrinsic dental staining using the Modified Lobene Stain Index, which assesses both the area and intensity of stain on selected tooth surfaces. The PI assigns a score from 0 to 3 for the area of stain, where 0 indicates no staining and 3 indicates stain covering more than two-thirds of the surface. Separately, the intensity of stain is scored from 0 to 3, where 0 indicates no stain and 3 indicates heavy dark staining. The final index is obtained by multiplying the area score by the intensity score. Higher values reflect more extensive and intense staining. Measurements are collected at baseline and at each follow-up (T0-T3).
Measured: Baseline to 6 months (T0-T3)
Patient Satisfaction via Self-Administered Questionnaire
To evaluate subjective satisfaction with the assigned toothpaste at the end of the study using a self-administered questionnaire. Participants will rate various aspects such as taste, texture, perceived effectiveness, and overall satisfaction. The PI will collect and score responses using a standardized Likert-type scale ranging from 1 (very dissatisfied) to 5 (very satisfied). The mean satisfaction score per participant will be analyzed and compared between the groups.
Measured: At 6 months (T3 only)
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 start25 Jul 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion10 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enamel HypomineralizationStudies 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
- Prevention
- 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
- NCT07069218
- Sponsor's protocol ID
- 2025-REMINEN
- Acronym
- HEREMI
- Status last verified
- Feb 2026
- First submitted
- 5 Jul 2025
- Last updated
- 20 Feb 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 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Two Hydroxyapatite-Based Toothpastes on Enamel Remineralization: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07069218
- Acronym / sponsor ID
- HEREMI / 2025-REMINEN
- Conditions
- Enamel Hypomineralization, Tooth Erosion
- Keywords
- Hydroxyapatite Toothpaste, Enamel Remineralization, DIAGNOcam, DIAGNOdent, Tooth Erosion, Dentin Sensitivity, Dental Plaque, Oral Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 10 Jun 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 randomized controlled clinical trial aims to evaluate the efficacy of two commercially available toothpastes containing hydroxyapatite in the remineralization of early enamel lesions. The study compares Biorepair® Total Protection Plus, which contains biomimetic microRepair particles, with Bioniq® Repair, a conventional hydroxyapatite-based toothpaste.
Forty participants will be randomly assigned to either the trial group (Biorepair®) or the control group (Bioniq®), and both groups will receive quarterly professional dental cleanings and use the assigned toothpaste twice daily for 6 months.
The primary outcome is the change in enamel demineralization, assessed by DIAGNOdent Pen scores, in permanent molar fissures and upper central incisors. Secondary outcomes include enamel integrity assessed by DIAGNOcam imaging and ICDAS scores, as well as changes in dental sensitivity (Schiff Air Index), erosive wear (BEWE Index), plaque accumulation (Plaque Index), gingival inflammation (Bleeding Index), and extrinsic stains (Modified Lobene Stain Index). Patient satisfaction will also be evaluated at the end of the study using a self-administered questionnaire.
This study will help determine whether biomimetic hydroxyapatite offers superior benefits in maintaining enamel health compared to conventional formulations, supporting evidence-based preventive strategies in dental care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biorepair Group | Experimental | Drug: Biorepair® Total Protection Plus ToothpasteParticipants receive professional oral hygiene sessions every 3 months and use Biorepair® Total Protection Plus toothpaste (biomimetic microRepair-based) twice daily for 6 months. |
| Bioniq Group | Active comparator | Drug: Bioniq® ToothpasteParticipants receive professional oral hygiene sessions every 3 months and use Bioniq® Repair toothpaste (conventional hydroxyapatite-based) twice daily for 6 months. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Subjects aged between 6 and 18 years
- Ability to understand and follow instructions in Italian or English
- Signed written informed consent provided by the parent/legal guardian and assent from the minor
- Good cooperation and adherence to clinical instructions
- Fully erupted permanent first molars and upper central incisors in good general condition
Key exclusion criteria (5 listed)
- DIAGNOdent Pen values greater than 25
- Ongoing systemic antibiotic therapy
- Presence of sealants or composite restorations on first permanent molars or upper central incisors
- Severe enamel alterations such as molar-incisor hypomineralization (MIH), fluorosis, or extensive white/brown spot lesions
- Poor motivation or limited compliance with study procedures
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® Total Protection Plus ToothpasteParticipants will use Biorepair® Total Protection Plus toothpaste twice daily for 6 months. The toothpaste contains biomimetic microRepair® particles based on zinc-substituted hydroxyapatite, intended to promote enamel remineralization, reduce sensitivity, and protect against erosion and plaque accumulation. Professional dental cleanings will also be performed every 3 months. | Drug | Biorepair Group |
| Bioniq® ToothpasteParticipants will use Bioniq® Repair toothpaste twice daily for 6 months. The toothpaste contains 20% conventional hydroxyapatite and is designed to restore enamel, reduce dentin hypersensitivity, and protect against erosion. Professional dental cleanings will also be performed every 3 months. | Drug | Bioniq Group |
Primary outcome
Change in DIAGNOdent Pen values in enamel fissures and upper central incisors
Time frame: Baseline to 6 months (T0-T3)
o assess the remineralizing efficacy of biomimetic hydroxyapatite (Biorepair® Total Protection Plus) compared to conventional hydroxyapatite (Bioniq® Repair) by evaluating the reduction in DIAGNOdent Pen fluorescence values recorded in the occlusal fissures of permanent molars and on the surfaces of upper central incisors. Measurements will be taken at four timepoints (T0, T1, T2, T3) over a 6-month period. The DIAGNOdent Pen provides a numerical score (0-99) based on laser fluorescence, where higher values indicate increased enamel demineralization. Lower values after treatment reflect improved enamel health and remineralization.
7 secondary outcomes
Change in ICDAS Scores via DIAGNOcam Imaging
Time frame: Baseline to 6 months (T0-T3)
Change in Dentin Hypersensitivity Using Schiff Air Index
Time frame: Baseline to 6 months (T0-T3)
Change in Enamel Erosion Using BEWE Index
Time frame: Baseline to 6 months (T0-T3)
Change in Plaque Accumulation Using Plaque Index
Time frame: Baseline to 6 months (T0-T3)
Change in Gingival Inflammation Using Bleeding Index
Time frame: Baseline to 6 months (T0-T3)
Change in Extrinsic Staining Using Modified Lobene Stain Index
Time frame: Baseline to 6 months (T0-T3)
Patient Satisfaction via Self-Administered Questionnaire
Time frame: At 6 months (T3 only)
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 20 Feb 2026.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the corresponding authors.
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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® Total Protection Plus Toothpaste and Bioniq® Toothpaste in people with Enamel Hypomineralization and Tooth Erosion, 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 5 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 20 Feb 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 DIAGNOdent Pen values in enamel fissures and upper central incisors (time frame: Baseline to 6 months (T0-T3)). 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 20 Feb 2026.