Early Caries Lesion Management Observational Study (ELMO)

CareQuest Institute for Oral Health

Status: Active, not recruiting

Conditions: Dental Caries; Dental Caries in Children; Initial Caries; Cavitated Caries; Arrested Dental Caries

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

Study type: Observational

Funder types: Other

Identifiers

NCT04933331

DQCI003

Details and patient eligibility

About

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.

Full description

Study subjects will be enrolled upon diagnosis of at least one ADA Caries Classification system "initial" caries lesion. Subjects will be further sorted into study cohorts based on the non-invasive treatment option they select. The early lesions will be followed for 24 months after the date of the initial caries lesion diagnosis or the date of the first non-invasive treatment applied to the lesion.

Patients who choose CRFP will serve as the primary variable of interest. The primary objective is to assess the effectiveness of CRFP compared to other tooth specific treatments (SDF, sealants, or other FDA-approved treatments) in preventing progression to cavitation in initial dental lesions. The primary endpoint will be measured by the percentage of patients that require operative treatment for at least one early lesion noted at baseline during the following 24 months of observation.

The secondary objectives are to assess the effectiveness of CRFP compared to no tooth-specific treatment (including whole mouth treatments such as: fluoride varnish, fluoride foam, prescription toothpaste; other FDA-approved treatments; and no treatment) on 1.) caries arrest and 2.) preventing progression to cavitation in patients with at least one early dental lesion. The secondary endpoints will be measured by 1.) the percentage of patients that have caries arrest for at least one early lesion noted at baseline during the following 24 months of observation and 2.) the percentage of patients that require operative treatment for at least one early lesion noted at baseline during the following 24 months of observation.

Enrollment: 744 estimated patients

Sex: All

Ages: 4+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

744 participants in 4 patient groups

Curodont Repair Fluoride Plus (Curodont) cohort

Description:

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.

Treatment:

Drug: Fluoride toothpaste

Drug: Curodont Repair Fluoride Plus

Device: Fluoride varnish

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

Description:

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.

Treatment:

Device: Glass Ionomer Sealant

Drug: Fluoride toothpaste

Device: Silver Diamine Fluoride

Device: Fluoride varnish

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

Description:

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.

Treatment:

Drug: Fluoride toothpaste

Device: Fluoride varnish

Orthodontic cohort

Description:

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.

Treatment:

Device: Glass Ionomer Sealant

Drug: Fluoride toothpaste

Device: Silver Diamine Fluoride

Drug: Curodont Repair Fluoride Plus

Device: Fluoride varnish