Hydroxyapatite Toothpastes and Enamel Remineralization:

Recruiting now · Not applicable

Conditions studied: Enamel Hypomineralization, Tooth Erosion

In brief

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.

Key facts

Study ID

NCT07069218

Run by

University of Pavia

People needed

40

Starts

2025-07-25

Expected to finish

2026-06-10

Last updated by the study team

2026-02-20

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify 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

Where it is running

• Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia — Pavia, Lombardy, Italy (enrolling)

Full record on ClinicalTrials.gov

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