Hydroxyapatite Toothpastes and Enamel Remineralization:
Status:
RECRUITING
Trial end date:
2026-02-15
Target enrollment:
Participant gender:
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.