A Phase 4 interventional study of 0.05% Sodium Fluoride with Self-Assembling Peptides in Incipient Interproximal Caries, sponsored by Tripler Army Medical Center. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Tripler Army Medical Center · Phase 4, Interventional, and Prevention
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 the subject's initial consent appointment.
The PI reviews the informed consent with the patient and gives patient the chance to ask questions.
Signed consent will be obtained and the subject will be provided a copy of the signed form.
At the baseline study visit, a baseline bitewing will first be taken. The sensor will be centered on the interproximal lesion(s) that is being treated.
Curodont Repair Fluoride Plus will then be applied to the lesion(s) per the manufacturer's instructions.
At this visit, the PI will review with the patient a thorough OHI (oral hygiene instruction) demo of proper brushing and flossing technique, reinforcing frequency and technique.
The patient will be scheduled to return at approximately 1 week, 1 month, and 3 months to obtain follow up bitewing radiographs of the treated lesion. The PI verbally reinforces OHI technique and frequency.
Images will be set with "No Real-Time Filter". Images will not be exported with enhancements or filters. Images will also not be exported with any identifiers.
Image processing software will be utilized to assess the radiographic effects of treatment.
The ROI (Region of Interest) will be defined by using a standardized rectangular box to not include sound enamel, the outer enamel surface, or the dentinoenamel junction. The ROI defined at Baseline will be saved in the image processing software and overlaid onto subsequent recall radiographs aligned via anatomical landmarks to ensure the exact same pixel area is measured.
Each subject will be assigned a unique subject ID to separate PHI from the study data. The Master Linking Log will be used to code the study data and will contain the unique subject ID, subject's name, DOB (date of birth), DOD (Department of Defense) ID, phone number, and enrollment date. The Master Linking Log will be password protected and stored on a DOD network. The coded data collection sheet will be maintained separately from the Master Linking Log and also stored with a password, on the DOD network, with access limited to study team members. The radiographs will be exported from the X-ray software in the Schofield Barracks Dental Clinic (SBDC) and stored on a CAC (Common Access Card) enabled government computer on the DOD network with limited access to just the study team.
The PI utilizes the "Relative Density" Formula: Relative Density = Mean Gray Value of the Lesion / Mean Gray Value of Sound Enamel. Sound Enamel will be defined as a radiopaque area on the enamel of the same tooth at least 2mm away from the interproximal carious lesion that is being treated. The area selected as Sound Enamel defined at baseline will be overlaid onto subsequent recall radiographs aligned via anatomical landmarks to ensure the exact same pixel area is measured. Result = 1.0: The lesion is as dense as healthy tooth. Result \< 1.0: The lesion is less dense.
The PI will compare the Mean Relative Density at Baseline vs. 1 week, 1 month, and 3 month utilizing One-Way Repeated Measures ANOVA. All statistical tests will be two-tailed with a significance level set at α = 0.05.
Tripler Army Medical Center is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Participants with non-cavitated interproximal carious lesions (E1, E2, or D1) receive a single topical application of Curodont Repair Fluoride Plus at baseline following standardized bitewing radiography and oral hygiene instruction.
Drug: 0.05% Sodium Fluoride with Self-Assembling Peptides
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.
Change in Mean Relative Radiographic Density of Interproximal Carious Lesions
Radiographic lesion density is evaluated using digital bitewing radiography and image processing software. Relative Density is calculated using the formula: Relative Density = (Mean Gray Value of the Lesion ROI) / (Mean Gray Value of Sound Enamel ROI). The Region of Interest (ROI) is standardized using a rectangular box avoiding sound enamel, the outer enamel border, and the DEJ, overlaid onto subsequent recall radiographs via anatomical landmark alignment. A value of 1.0 indicates lesion density equal to healthy sound enamel, whereas values \< 1.0 indicate lower mineral density. Changes from baseline will be evaluated to assess remineralization and lesion arrest.
Time frame: From enrollment to the end of treatment at 3 months. Measurements will be recorded periodically at baseline, 1 week after treatment, 1 month after treatment, and 3 months after treatment.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — As outlined in the protocol, data collected from military beneficiaries at Schofield Barracks Dental Clinic is protected under strict DoD Information Assurance and Privacy Act guidelines (stored on CAC-enabled, password-protected DoD networks). IPD (Individual Participant Data) containing military identifiers/records cannot be freely shared or distributed to outside researchers without explicit institutional and DoD approval.
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Tripler Army Medical Center