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New treatment option for Enamel Hypomineralization
Official title Hydroxyapatite Toothpastes and Enamel Remineralization:
ClinicalTrials.gov ID: NCT07069218
What this study is testing
What is Biorepair® Total Protection Plus Toothpaste?
Biorepair® Total Protection Plus Toothpaste is an investigational medicine, given as an once-daily, being studied as a potential treatment for enamel hypomineralization.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 18
You may be able to join if
- people 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
You likely can't join if
- 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
See the full eligibility criteria
- people 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Pavia, Lombardy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pavia, Lombardy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.