Early Caries Lesion Management Observational Study (ELMO)

February 6, 2023 updated by: Laura Skaret, CareQuest Institute for Oral Health

An Observational Multi-cite Study to Evaluate and Compare the Effectiveness of Various Tooth Specific Treatments in the Management of Early Caries Lesions

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

744

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Sarrell Dental Clinic
    • Massachusetts
      • Westborough, Massachusetts, United States, 01581
        • DentaQuest (Advantage Dental) Oral Health Center
    • Oregon
      • Bend, Oregon, United States, 97701
        • Advantage Dental Oral Health Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Community Dental Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • Curolox
  • p11-4
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.
Other Names:
  • Prevident
  • Clinpro
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: 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.
Other Names:
  • Prevident
  • Clinpro
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.
Other Names:
  • Silver Nitrate
  • SDF
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.
Other Names:
  • GI Sealant
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
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.
Other Names:
  • Prevident
  • Clinpro
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
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.
Other Names:
  • Curolox
  • p11-4
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.
Other Names:
  • Prevident
  • Clinpro
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.
Other Names:
  • Silver Nitrate
  • SDF
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.
Other Names:
  • GI Sealant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the effectiveness of CRFP compared to other tooth specific treatments in preventing progression to cavitation.
Time Frame: 24 months
The percentage of patients treated with CRFP that require operative treatment for at least one early lesion within the 24 months.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the effectiveness of CRFP compared to no tooth specific treatments (including whole mouth treatments) on caries arrest.
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months
The percentage of patients that have caries arrest for at least one early lesion noted at baseline during the 24 months of observation from baseline.
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.
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months
The percentage of patients that require operative treatment for at least one early lesion noted at baseline during the 24 months of observation from baseline.
Baseline, 6 months, 12 months, 18 months, 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months
The percentage of lesions treated with SDF that have caries arrest for at least one early lesion noted at baseline during the 24 months of observation from baseline.
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.
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months
The percentage of lesions treated with SDF that require operative treatment for at least one early lesion noted at baseline during the 24 months of observation from baseline.
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.
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months
The percentage of lesions treated with sealants that require operative treatment for at least one early lesion noted at baseline during the 24 months of observation from baseline.
Baseline, 6 months, 12 months, 18 months, 24 months
To assess the effectiveness of CRFP compared to sealants in preventing progression to cavitation.
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months
The percentage of lesions treated with CRFP that require operative treatment compared to those treated with sealants during the 24 months of observation from baseline.
Baseline, 6 months, 12 months, 18 months, 24 months
To assess the effectiveness of CRFP compared to SDF in preventing progression to cavitation.
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months
The percentage of lesions treated with CRFP that require operative treatment compared to those treated with SDF during the 24 months of observation from baseline.
Baseline, 6 months, 12 months, 18 months, 24 months
To assess the effectiveness of CRFP compared to SDF (silver diamine fluoride) on caries arrest in patients with at least one early dental lesion.
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months
The percentage of lesions treated with CRFP that have caries arrest compared to those treated with SDF that have caries arrest during the 24 months of observation from baseline.
Baseline, 6 months, 12 months, 18 months, 24 months
To assess the effectiveness of sealants compared to SDF (silver diamine fluoride) in preventing progression to cavitation in patients with at least one early dental lesion.
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months
The percentage of lesions treated with SDF that require operative treatment compared to those treated with sealants during the 24 months of observation from baseline.
Baseline, 6 months, 12 months, 18 months, 24 months
To assess the effectiveness of tooth specific treatments in patients who are actively undergoing orthodontic care and have at least one early dental lesion.
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months
A comparison of lesions that have caries arrest or require operative treatment for early lesion interventions during the 24 months of observation from baseline.
Baseline, 6 months, 12 months, 18 months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CareQuest Institute for Oral Health

Investigators

  • Principal Investigator: Laura J Skaret, BS, CareQuest Innovation Partners

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 7, 2020

Primary Completion (ANTICIPATED)

June 30, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

June 18, 2021

First Posted (ACTUAL)

June 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DQCI003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study data will be deidentified and stored on a secure server. There will be no plans to release individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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