Hydroxyapatite Toothpastes and Enamel Remineralization:

Phase

N/A

Condition

N/A

Treatment

Bioniq® Toothpaste

Biorepair® Total Protection Plus Toothpaste

Clinical Study ID

NCT07069218

2025-REMINEN

Ages 6-18
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 assentfrom the minor
Good cooperation and adherence to clinical instructions
Fully erupted permanent first molars and upper central incisors in good generalcondition
DIAGNOdent Pen baseline values in the C1 (0-12) or C2 (13-24) range

Exclusion

Exclusion Criteria:

DIAGNOdent Pen values greater than 25
Ongoing systemic antibiotic therapy
Presence of sealants or composite restorations on first permanent molars or uppercentral 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

Study Design