Comparing two hydroxyapatite toothpastes to help repair early enamel damage

Efficacy of Two Hydroxyapatite-Based Toothpastes on Enamel Remineralization: A Randomized Controlled Trial

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

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 6 Years to 18 Years
• Sex: All
• Sponsor: University of Pavia (other)
• Locations: 1 site (Pavia, Lombardy)
• Trial ID: NCT07069218 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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

Where this trial is running

Pavia, Lombardy

• 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

Conditions: Enamel Hypomineralization, Tooth Erosion, Hydroxyapatite Toothpaste, Enamel Remineralization, DIAGNOcam, DIAGNOdent, Dentin Sensitivity, Dental Plaque