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 — DRUGSingle 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 GroupParticipants 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Schofield Barracks Dental Clinic | Schofield Barracks | Hawaii | 96857 | - |
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