Clinical trial NCT04933331: Early Caries Lesion Management Observational Study
Official title: An Observational Multi-cite Study to Evaluate and Compare the Effectiveness of Various Tooth Specific Treatments in the Management of Early Caries Lesions
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Initial Caries
Arrested Dental Caries
Cavitated Caries
Dental Caries
Dental Caries in Children
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
Lead sponsor: CareQuest Institute for Oral Health
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 744
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: To assess the effectiveness of CRFP compared to other tooth specific treatments in preventing progression to cavitation.
timeFrame: 24 months
Secondary outcomes:
measure: To assess the effectiveness of CRFP compared to no tooth specific treatments (including whole mouth treatments) on caries arrest.
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: To assess the effectiveness of CRFP compared to no tooth specific treatment (including whole mouth treatment) in preventing progression to cavitation.
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
Other outcomes:
measure: 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.
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: To assess the effectiveness of SDF (silver diamine fluoride) compared to no tooth specific treatment (including whole mouth treatment) in preventing progression to cavitation.
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: To assess the effectiveness of sealants compared to no tooth specific treatment (including whole mouth treatment) in preventing progression to cavitation.
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: To assess the effectiveness of CRFP compared to sealants in preventing progression to cavitation.
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: To assess the effectiveness of CRFP compared to SDF in preventing progression to cavitation.
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: To assess the effectiveness of CRFP compared to SDF (silver diamine fluoride) on caries arrest in patients with at least one early dental lesion.
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: 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.
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: To assess the effectiveness of tooth specific treatments in patients who are actively undergoing orthodontic care and have at least one early dental lesion.
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
Locations:
city: Dothan
country: United States
facility: Sarrell Dental Clinic
state: Alabama
city: Westborough
country: United States
facility: DentaQuest (Advantage Dental) Oral Health Center
state: Massachusetts
city: Bend
country: United States
facility: Advantage Dental Oral Health Center
state: Oregon
city: Dallas
country: United States
facility: Community Dental Care
state: Texas
Study officials:
affiliation: CareQuest Innovation Partners
name: Laura J Skaret, BS
role: PRINCIPAL_INVESTIGATOR
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