Can SAP P11-4 Affect The Appearance of Interproximal Cavities on an X-ray in a Military Population

Part of paid clinical trials in Schofield Barracks, Hawaii.

Sponsor
Tripler Army Medical Center
Study ID
NCT07829328
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Incipient Interproximal Caries

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • 0.05% Sodium Fluoride with Self-Assembling Peptides — DRUG
    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.

Study Details

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.

Key Dates

First listed
Sep 21, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Feb 28, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Curodont Repair Fluoride Plus Treatment Group
    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.

Primary Outcome Measure

Change in Mean Relative Radiographic Density of Interproximal Carious Lesions [ 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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Schofield Barracks Dental ClinicSchofield BarracksHawaii96857-

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