Hydroxyapatite Toothpastes and Enamel Remineralization:

Condition(s) studied

Investigational drug(s) / intervention(s)

Biorepair® Total Protection Plus Toothpaste: Participants will use Biorepair® Total Protection Plus toothpaste twice daily for 6 months. The toothpaste contains biomimetic microRepair® particles based on zinc-substituted hydroxyapatite, intended to promote enamel remineralization, reduce sensitivity, and protect against erosion and plaque accumulation. Professional dental cleanings will also be performed every 3 months.

Bioniq® Toothpaste: Participants will use Bioniq® Repair toothpaste twice daily for 6 months. The toothpaste contains 20% conventional hydroxyapatite and is designed to restore enamel, reduce dentin hypersensitivity, and protect against erosion. Professional dental cleanings will also be performed every 3 months.

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

Primary outcome measure(s)

• Change in DIAGNOdent Pen values in enamel fissures and upper central incisors — Baseline to 6 months (T0-T3)
  o assess the remineralizing efficacy of biomimetic hydroxyapatite (Biorepair® Total Protection Plus) compared to conventional hydroxyapatite (Bioniq® Repair) by evaluating the reduction in DIAGNOdent Pen fluorescence values recorded in the occlusal fissures of permanent molars and on the surfaces of upper central incisors. Measurements will be taken at four timepoints (T0, T1, T2, T3) over a 6-month period. The DIAGNOdent Pen provides a numerical score (0-99) based on laser fluorescence, where higher values indicate increased enamel demineralization. Lower values after treatment reflect improved enamel health and remineralization.

Trial sites (1)

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