Hydroxyapatite Toothpastes and Enamel Remineralization:

NCT07069218 | Recruiting

• 1 other identifier: 2025-REMINEN
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tooth Erosion; Enamel Hypomineralization

Keywords

Hydroxyapatite Toothpaste; Enamel Remineralization; DIAGNOcam; DIAGNOdent; Tooth Erosion; Dentin Sensitivity; Dental Plaque; Oral Health; Randomized Controlled Trial; Preventive Dentistry

Outcome Measures

Primary Outcomes (1)

• Change in DIAGNOdent Pen values in enamel fissures and upper central incisors

  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.

  Baseline to 6 months (T0-T3)

Secondary Outcomes (7)

• Change in ICDAS Scores via DIAGNOcam Imaging

  Baseline to 6 months (T0-T3)

• Change in Dentin Hypersensitivity Using Schiff Air Index

  Baseline to 6 months (T0-T3)

• Change in Enamel Erosion Using BEWE Index

  Baseline to 6 months (T0-T3)

• Change in Plaque Accumulation Using Plaque Index

  Baseline to 6 months (T0-T3)

• Change in Gingival Inflammation Using Bleeding Index

  Baseline to 6 months (T0-T3)

Study Arms (2)

Biorepair Group

EXPERIMENTAL

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

Drug: Biorepair® Total Protection Plus Toothpaste

Bioniq Group

ACTIVE COMPARATOR

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

Drug: Bioniq® Toothpaste

Interventions

Biorepair® Total Protection Plus Toothpaste DRUG

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.

Biorepair Group

Bioniq® Toothpaste DRUG

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.

Bioniq Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Dental Enamel Hypomineralization; Tooth Erosion; Dentin Sensitivity; Dental Plaque

Interventions

Toothpastes

Condition Hierarchy (Ancestors)

Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Tooth Demineralization; Tooth Wear; Dental Deposits

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Andrea Scribante, Associate Professor

  University of Pavia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Scribante, Associate Professor

CONTACT

+39 0382516223; andrea.scribante@unipv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 16, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 10, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)