Early Caries Lesion Management Observational Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Initial Caries, Arrested Dental Caries, Cavitated Caries, Dental Caries, Dental Caries in Children

Intervention / Treatment
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* Drug: Curodont Repair Fluoride Plus
* Device: Silver Diamine Fluoride
* Device: Glass Ionomer Sealant
* Device: Fluoride varnish
* Drug: Fluoride toothpaste


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Curodont Repair Fluoride Plus (Curodont) cohort<br>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<br>* 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.<br>* Other names: p11-4;Device: Fluoride varnish<br>* 2.5% Sodium Fluoride Varnish which reduces dentinal hypersensitivity by occluding dentinal tubules.<br>Drug: Fluoride toothpaste<br>* Prescription sodium fluoride toothpaste medicament used in place of regular toothpaste. It works by making the teeth stronger and more resistant to caries.<br>* Other names: Clinpro;|
| Other tooth-specific initial lesion interventional treatments cohort(s)<br>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<br>* 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.<br>* Other names: Silver Nitrate;Device: Glass Ionomer Sealant<br>* 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.<br>* Other names: GI Sealant;Device: Fluoride varnish<br>* 2.5% Sodium Fluoride Varnish which reduces dentinal hypersensitivity by occluding dentinal tubules.<br>Drug: Fluoride toothpaste<br>* Prescription sodium fluoride toothpaste medicament used in place of regular toothpaste. It works by making the teeth stronger and more resistant to caries.<br>* Other names: Clinpro;|
| Control cohort, no tooth-specific treatment or whole mouth treatment.<br>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<br>* 2.5% Sodium Fluoride Varnish which reduces dentinal hypersensitivity by occluding dentinal tubules.<br>Drug: Fluoride toothpaste<br>* Prescription sodium fluoride toothpaste medicament used in place of regular toothpaste. It works by making the teeth stronger and more resistant to caries.<br>* Other names: Clinpro;|
| Orthodontic cohort<br>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<br>* 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.<br>* Other names: p11-4;Device: Silver Diamine Fluoride<br>* 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.<br>* Other names: Silver Nitrate;Device: Glass Ionomer Sealant<br>* 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.<br>* Other names: GI Sealant;Device: Fluoride varnish<br>* 2.5% Sodium Fluoride Varnish which reduces dentinal hypersensitivity by occluding dentinal tubules.<br>Drug: Fluoride toothpaste<br>* Prescription sodium fluoride toothpaste medicament used in place of regular toothpaste. It works by making the teeth stronger and more resistant to caries.<br>* Other names: Clinpro;|

What is the study measuring?
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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. | 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. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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