early caries lesion management observational study

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

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.

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.

Eligibility criteria:
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

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