Initial Caries, Arrested Dental Caries, Cavitated Caries, Dental Caries, Dental Caries in Children
Conditions
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
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.
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.
Interventions
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.
DEVICESilver 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.
DEVICEGlass 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.
DEVICEFluoride varnish
2.5% Sodium Fluoride Varnish which reduces dentinal hypersensitivity by occluding dentinal tubules.
DRUGFluoride 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
CareQuest Institute for Oral Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the effectiveness of CRFP compared to other tooth specific treatments in preventing progression to cavitation. | 24 months | The percentage of patients treated with CRFP that require operative treatment for at least one early lesion within the 24 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| To assess the effectiveness of CRFP compared to sealants in preventing progression to cavitation. | 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. |
| To assess the effectiveness of CRFP compared to SDF in preventing progression to cavitation. | 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. |
| 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 | 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. |
| 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. | 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. |
| To assess the effectiveness of tooth specific treatments in patients who are actively undergoing orthodontic care and have at least one early dental lesion. | 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. |
| To assess the effectiveness of CRFP compared to SDF (silver diamine fluoride) on caries arrest in patients with at least one early dental lesion. | 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. |
| 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 | 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. |
| 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 | 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. |
Countries
United States
Outcome results
None listed