Early Caries Lesion Management Observational Study

NCT04933331 | Unknown DMC FDA Drug FDA Device

• 1 other identifier: DQCI003
• Study Type: observational
• Target: 744
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Curodont Repair Fluoride Plus; silver diamine fluoride; glass ionomer sealants; Fluoride Varnish; minimally invasive dentistry; non-invasive dentistry; Initial Caries; Arrested Dental Caries; dental caries; Cavitated Caries; Restorative Dental Treatment; Dental restorations

Outcome Measures

Primary Outcomes (1)

• To assess the effectiveness of CRFP compared to other tooth specific treatments in preventing progression to cavitation.

  The percentage of patients treated with CRFP that require operative treatment for at least one early lesion within the 24 months.

  24 months

Secondary Outcomes (2)

• To assess the effectiveness of CRFP compared to no tooth specific treatments (including whole mouth treatments) on caries arrest.

  Baseline, 6 months, 12 months, 18 months, 24 months

• To assess the effectiveness of CRFP compared to no tooth specific treatment (including whole mouth treatment) in preventing progression to cavitation.

  Baseline, 6 months, 12 months, 18 months, 24 months

Other Outcomes (8)

• To assess the effectiveness of SDF compared to no tooth specific treatment (including whole mouth treatment) on caries arrest in patients with at least one early dental lesion.

  Baseline, 6 months, 12 months, 18 months, 24 months

• To assess the effectiveness of SDF (silver diamine fluoride) compared to no tooth specific treatment (including whole mouth treatment) in preventing progression to cavitation.

  Baseline, 6 months, 12 months, 18 months, 24 months

• To assess the effectiveness of sealants compared to no tooth specific treatment (including whole mouth treatment) in preventing progression to cavitation.

  Baseline, 6 months, 12 months, 18 months, 24 months

Study Arms (4)

Curodont Repair Fluoride Plus (Curodont) cohort

The effectiveness of Curodont treatment in this group will be compared to other treatment options and cohorts. Curodont will be professionally applied in the dental clinic. The treatment time takes about 5 minutes. Patients receive one professional dose application and be provided with homecare instructions and will be instructed to return for regular dental visits and exams according to the frequency determined by their dental team, usually every 6 months.

Drug: Curodont Repair Fluoride Plus; Device: Fluoride varnish; Drug: Fluoride toothpaste

Other tooth-specific initial lesion interventional treatments cohort(s)

Silver Diamine Fluoride (SDF). The treatment time is about 2 minutes. Glass Ionomer Sealants: The treatment time takes about 5 minutes per sealant. Typically four sealants are completed in one visit. All patients will be provided with homecare instructions and will be instructed to return for regular dental visits and exams according to the frequency determined by their dental team, usually every 6 months.

Device: Silver Diamine Fluoride; Device: Glass Ionomer Sealant; Device: Fluoride varnish; Drug: Fluoride toothpaste

Control cohort, no tooth-specific treatment or whole mouth treatment.

If a patient or their caregivers choose no tooth-specific treatment, they will be included in the control cohort. This group includes patients who chose to receive no treatment at all, as well as those who choose whole mouth treatments such as: 2.26% fluoride varnish, 1.23% fluoride foam, and 5000 ppm fluoride prescription toothpaste.

Device: Fluoride varnish; Drug: Fluoride toothpaste

Orthodontic cohort

Patients in active orthodontic care will be analyzed separately from other patients to account for the impact of orthodontic appliances on treatment outcomes. Orthodontic appliances are recognized by the American Dental Association Caries Risk Assessment as a risk factor for caries because they create dental plaque stagnation areas that are difficult to clean. Initial caries lesions are very frequently seen immediately surrounding orthodontic brackets (braces), yet continued plaque stagnation over the treated areas may heavily influence the success of any treatment. All groups/cohorts above will be represented in the orthodontic cohort in parallel.

Drug: Curodont Repair Fluoride Plus; Device: Silver Diamine Fluoride; Device: Glass Ionomer Sealant; Device: Fluoride varnish; Drug: Fluoride toothpaste

Interventions

Curodont Repair Fluoride Plus DRUG

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.

Also known as: Curolox, p11-4

Curodont Repair Fluoride Plus (Curodont) cohort; Orthodontic cohort

Silver Diamine Fluoride DEVICE

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.

Also known as: SDF, Silver Nitrate

Orthodontic cohort; Other tooth-specific initial lesion interventional treatments cohort(s)

Glass Ionomer Sealant DEVICE

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.

Also known as: GI Sealant

Orthodontic cohort; Other tooth-specific initial lesion interventional treatments cohort(s)

Fluoride varnish DEVICE

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

Control cohort, no tooth-specific treatment or whole mouth treatment.; Curodont Repair Fluoride Plus (Curodont) cohort; Orthodontic cohort; Other tooth-specific initial lesion interventional treatments cohort(s)

Fluoride toothpaste DRUG

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

Also known as: Prevident, Clinpro

Control cohort, no tooth-specific treatment or whole mouth treatment.; Curodont Repair Fluoride Plus (Curodont) cohort; Orthodontic cohort; Other tooth-specific initial lesion interventional treatments cohort(s)

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This project will include patients of specified DentaQuest CareGroup clinics in Massachusetts, Alabama, Texas, and Oregon. There will be no special inclusion/exclusion criteria by race and/or ethnic origin. * The pediatric cohort will include patients with permanent teeth up to the 21st birthday. * The orthodontic cohort will include all ages. * The adult cohort will include all patients age 21 and above.

You may qualify if:

• All patients with permanent teeth who are diagnosed with at least one American Dental Association Caries Classification System (ADACCS) "Initial" caries lesion in a permanent tooth, will be included in this analysis.

You may not qualify if:

• Primary teeth
• Permanent teeth with ADACCS "Moderate" or "Advanced" caries lesions
• Healthy/ ADACCS "Sound" teeth

Sponsors & Collaborators

• CareQuest Institute for Oral Health: lead

Study Sites (4)

Sarrell Dental Clinic

Dothan, Alabama, 36303, United States

Location

DentaQuest (Advantage Dental) Oral Health Center

Westborough, Massachusetts, 01581, United States

Location

Advantage Dental Oral Health Center

Bend, Oregon, 97701, United States

Location

Community Dental Care

Dallas, Texas, 75246, United States

Location

Related Publications (16)

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• Shah SV, Kibbe LJ, Heaton LJ, Desrosiers C, Wittenborn J, Filipova M, Zaydenman K, Keeper JH. Framework for fiscal impact analysis of managing initial caries lesions with noninvasive therapies. J Am Dent Assoc. 2023 Oct;154(10):897-909.e6. doi: 10.1016/j.adaj.2023.07.007.

  PMID: 37770132 DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

Silver Staining; Sodium Fluoride; Clinpro Sealant

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Laura J Skaret, BS

  CareQuest Innovation Partners

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Laura Kibbe, BSDH, Clinical Innovation Manager

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 21, 2021
• Study Start: December 7, 2020
• Primary Completion: November 15, 2023
• Study Completion: March 31, 2024
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)