Early Caries Lesion Management Observational Study

Summary

The purpose of this observational study is to assess the effectiveness of Curodont Repair Fluoride Plus (CRFP) compared to other tooth-specific treatments (silver diamine fluoride (SDF), sealants, or other FDA-approved treatments) in preventing progression to cavitation in patients with at least one early non-cavitated dental caries lesion.

The study will also evaluate the effectiveness of CRFP in comparison to no tooth-specific treatment control groups, including whole mouth treatments such as: 2.26% fluoride varnish, 1.23% fluoride foam, and 5000 ppm fluoride prescription toothpaste; and no treatment, on caries arrest and in preventing progression to cavitation in patients with at least one early non-cavitated dental lesion.

Conditions

• Initial Caries
• Arrested Dental Caries
• Cavitated Caries
• Dental Caries
• Dental Caries in Children

Interventions

DRUG

Curodont Repair Fluoride Plus

Self-assembling peptide that integrates calcium and phosphate ions into the same hydroxyapatite that the enamel is made of through biomimetic re-mineralization. Amino acid sequence: CH3,COQQRFEWEFEQQ,NH2.

DEVICE

Silver Diamine Fluoride

Silver diamine fluoride 38% is indicated for the treatment of dentinal hypersensitivity. SDF works by killing pathogenic organisms and hardens softened dentin making it more acid and abrasion resistant. The ADA recommends the use of SDF in treating early lesions.

DEVICE

Glass Ionomer Sealant

A hydrophilic type of sealant material made with water, polymeric acid, and glass power. These sealants release fluoride over time which also helps protect against and repair initial caries lesions. The ADA recommends the use of sealants in treating occlusal early lesions.

DEVICE

Fluoride varnish

2.5% Sodium Fluoride Varnish which reduces dentinal hypersensitivity by occluding dentinal tubules.

DRUG

Fluoride toothpaste

Prescription sodium fluoride toothpaste medicament used in place of regular toothpaste. It works by making the teeth stronger and more resistant to caries.

Sponsors & Collaborators

• CareQuest Institute for Oral Health

  lead OTHER

Principal Investigators

• Laura J Skaret, BS · CareQuest Innovation Partners

Eligibility

Min Age

4 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-12-07

Primary Completion

2023-11-15

Completion

2024-03-31

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations