Hydroxyapatite Toothpastes and Enamel Remineralization: (HEREMI)

University of Pavia

Status: Enrolling

Conditions: Enamel Hypomineralization; Tooth Erosion

Treatments: Drug: Biorepair® Total Protection Plus Toothpaste; Drug: Bioniq® Toothpaste

Study type: Interventional

Funder types: Other

Identifiers

NCT07069218

2025-REMINEN

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Biorepair Group

Experimental group

Description:

Participants receive professional oral hygiene sessions every 3 months and use Biorepair® Total Protection Plus toothpaste (biomimetic microRepair-based) twice daily for 6 months.

Treatment:

Drug: Biorepair® Total Protection Plus Toothpaste

Bioniq Group

Active Comparator group

Description:

Participants receive professional oral hygiene sessions every 3 months and use Bioniq® Repair toothpaste (conventional hydroxyapatite-based) twice daily for 6 months.

Treatment:

Drug: Bioniq® Toothpaste