What this study is
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.
What's being tested
- 0.05% Sodium Fluoride with Self-Assembling Peptides
Intervention · 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
- Official title
- Can SAP P11-4 Increase The Radiopacity of Incipient Interproximal Carious Lesions on a Radiograph in a Military Population
- Sponsor
- Tripler Army Medical Center
- Conditions
- Incipient Interproximal Caries
- Enrolling
- 30 people
- Starts
- 2026-09-30
- Est. completion
- 2027-08
- Design
- Open-label, single group, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 74 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Non-active duty military
- Interproximal carious lesions that are cavitated or D2-D3 in radiographic depth
- Tobacco, nicotine, and e-cigarette use
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openSchofield Barracks Dental Clinic
Schofield Barracks, Hawaii, United States
Study team
Sponsor
Tripler Army Medical Center
Study ID SAPP114
Principal investigator
Steven Phung, DMD
Tripler Army Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.