Tripler Army Medical Center
The primary objective of the protocol is to learn about how SAP P 11-4 (produced commercially as Curodont products) can be used in a military population to treat incipient dental caries, or developing cavities that are still structurally intact and not too deep and increase awareness of the improvement and availability of minimally invasive treatment options for cavities in a military population.
Potential subjects who have at least one interproximal incipient lesion on bitewing radiograph that is E1 (halfway into enamel), E2 (more than halfway into enamel), or D1 (into the outer third of dentin) will be identified through referral from dental providers at the Schofield Barracks Dental Clinic (SBDC). Subjects must have non-cavitated lesions (verified clinically where possible or by the absence of a visible break in the enamel surface on the radiograph). Patients will be contacted by the principal investigator (PI) after a referral is made from a referring dentist. The PI will schedule…
Inclusion Criteria: * Active Duty military * must have 1 or more incipient, non-cavitated, interproximal carious lesions (E1, E2, or D1 in radiographic depth) * must have time remaining on post for at least 4 months from the start of treatment/enrollment Exclusion Criteria: * non-active duty military * interproximal carious lesions that are cavitated or D2-D3 in radiographic depth * tobacco, nicotine, and e-cigarette use
Single topical application of Curodont Repair Fluoride Plus (containing 0.05% sodium fluoride and self-assembling P11-4 peptide technology) directly to identified non-cavitated interproximal early carious lesions (radiographic stages E1, E2, or D1) at baseline per manufacturer instructions. Participants receive standardized oral hygiene instruction (OHI) reinforcing brushing and flossing technique and frequency at baseline and at all recall appointments. Follow-up standardized bitewing radiographs are obtained at 1 week, 1 month, and 3 months with no real-time filters or enhancements to evaluate lesion density changes via pixel region-of-interest (ROI) analysis.
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