Hydroxyapatite Toothpastes and Enamel Remineralization:
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biorepair® Total Protection Plus Toothpaste, Bioniq® Toothpaste.
- Who it may be relevant to
- Registry conditions: Enamel Hypomineralization, Tooth Erosion. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of Two Hydroxyapatite-Based Toothpastes on Enamel Remineralization: A Randomized Controlled Trial
Overview
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.
Interventions
- Drug 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. - Drug 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.
Primary outcome measures
- Change in DIAGNOdent Pen values in enamel fissures and upper central incisors [Time frame: Baseline to 6 months (T0-T3)]
Secondary outcome measures (7)
- 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)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Italy · 1 center
- Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinic — Pavia
Identifiers
NCT: NCT07069218 · 2025-REMINEN