Hydroxyapatite Toothpastes and Enamel Remineralization:
NCT ID: NCT07069218
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-07-25
2026-02-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Biorepair Group
Participants receive professional oral hygiene sessions every 3 months and use Biorepair® Total Protection Plus toothpaste (biomimetic microRepair-based) twice daily for 6 months.
Biorepair® Total Protection Plus Toothpaste
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 Group
Participants receive professional oral hygiene sessions every 3 months and use Bioniq® Repair toothpaste (conventional hydroxyapatite-based) twice daily for 6 months.
Bioniq® Toothpaste
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.
Interventions
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Biorepair® Total Protection Plus Toothpaste
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® Toothpaste
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
6 Years
18 Years
ALL
No
Sponsors
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University of Pavia
OTHER
Responsible Party
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Andrea Scribante
Associate Professor, Principal Investigator
Principal Investigators
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Andrea Scribante, Associate Professor
Role: PRINCIPAL_INVESTIGATOR
University of Pavia
Locations
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Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-REMINEN
Identifier Type: -
Identifier Source: org_study_id
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