Comparing two hydroxyapatite toothpastes to help repair early enamel damage
Official title: Efficacy of Two Hydroxyapatite-Based Toothpastes on Enamel Remineralization: A Randomized Controlled Trial
Run by University of Pavia · NCT07069218 · Data updated 2026-11-12
This trial will try two hydroxyapatite toothpastes in children and teens with early enamel mineral loss to see which restores enamel mineral and reduces sensitivity better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 18 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Pavia Academic / other |
| Locations | 1 site (Pavia, Lombardy) |
| Status | Recruiting |
| Started | July 25, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | June 10, 2026 |
| Registry record updated | February 20, 2026 |
| Trial ID | NCT07069218 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are cooperative children and adolescents (ages 6–18) with fully erupted permanent first molars and upper central incisors, early enamel lesions (DIAGNOdent values 0–24), and parental consent/assent.
✕Probably not a fit
Patients with severe enamel defects (MIH, fluorosis, extensive white/brown lesions), DIAGNOdent values over 25, existing sealants or composite restorations on the target teeth, ongoing systemic antibiotics, or poor compliance are unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial will enroll 40 participants aged 6–18 and randomly assign them to use either Biorepair® Total Protection Plus or Bioniq® toothpaste twice daily for six months. Both groups will receive quarterly professional dental cleanings and standardized oral hygiene instructions. The primary outcome is change in enamel demineralization measured by DIAGNOdent Pen scores on permanent first molar fissures and upper central incisors. Secondary outcomes include DIAGNOcam imaging and ICDAS visual scores, dental sensitivity (Schiff Air Index), erosive wear (BEWE Index), plaque accumulation, and gingival inflammation.
Why it matters
Potential benefit: If successful, the tested toothpaste could provide a simple, non-invasive home-care option to remineralize early enamel lesions and reduce dental sensitivity in children and adolescents.
How similar studies have gone: Previous clinical studies of hydroxyapatite-containing toothpastes have shown promising remineralization and sensitivity reduction, but direct head-to-head comparisons of these specific brands are limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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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 Recruiting
Study contacts
- Principal investigator: Andrea Scribante, Associate Professor — University of Pavia
- Study coordinator: Andrea Scribante, Associate Professor
- Email: andrea.scribante@unipv.it
- Phone: +39 0382516223
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.