Incipient Interproximal CariesPhase 4NCT07829328
Can SAP P11-4 Affect The Appearance of Interproximal Cavities on an X-ray in a Military Population
A Phase 4 study testing 0.05% Sodium Fluoride with Self-Assembling Peptides in people with Incipient Interproximal Caries, run by Tripler Army Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Incipient Interproximal Caries
- What is being tested?
- 0.05% Sodium Fluoride with Self-Assembling Peptides
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- non-active duty military
- interproximal carious lesions that are cavitated or D2-D3 in radiographic depth
- tobacco, nicotine, and e-cigarette use
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Schofield Barracks Dental Clinic
Schofield Barracks, Hawaii, 96857
About this study
Official title: Can SAP P11-4 Increase The Radiopacity of Incipient Interproximal Carious Lesions on a Radiograph in a Military Population
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.
Read the detailed description
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.
- Conditions
- Incipient Interproximal Caries
- Being tested
- 0.05% Sodium Fluoride with Self-Assembling Peptides
- Keywords
- Self-assembling peptide, remineralization, caries, incipient caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.05% Sodium Fluoride with Self-Assembling PeptidesDrug
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 group | Role | What they receive |
|---|---|---|
| Curodont Repair Fluoride Plus Treatment Group | Experimental | 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. Receives: Drug: 0.05% Sodium Fluoride with Self-Assembling Peptides |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Incipient Interproximal CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tripler Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Steven Phung, DMD, Principal investigator, Tripler Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829328
- Sponsor's protocol ID
- SAPP114
- Status last verified
- Aug 2026
- First submitted
- 1 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Thakur S, Sojan M, Singhal P, Chauhan D. A Comparative Study to Evaluate the Effectiveness of Silver Diamine Fluoride at Different Time Durations of Application in Treating Carious Primary Teeth: A Randomized Trial. Int J Clin Pediatr Dent. 2022;15(Suppl 2):S147-S150. doi: 10.5005/jp-journals-10005-2326.
PubMed 35645534Sleibi A, Tappuni A, Mills D, Davis GR, Baysan A. Comparison of the Efficacy of Different Fluoride Varnishes on Dentin Remineralization During a Critical pH Exposure Using Quantitative X-Ray Microtomography. Oper Dent. 2018 Nov/Dec;43(6):E308-E316. doi: 10.2341/18-014-L.
PubMed 30457948Shaalan O, Fawzy El-Sayed K, Abouauf E. Evaluation of the remineralization potential of self-assembling peptide P11-4 with fluoride compared to fluoride varnish in the management of incipient carious lesions: a randomized controlled clinical trial. Clin Oral Investig. 2024 Jul 22;28(8):438. doi: 10.1007/s00784-024-05822-z.
PubMed 39037455Pitts NB, Rimmer PA. An in vivo comparison of radiographic and directly assessed clinical caries status of posterior approximal surfaces in primary and permanent teeth. Caries Res. 1992;26(2):146-52. doi: 10.1159/000261500.
PubMed 1521308Padilla-Caceres TC, Arbildo-Vega HI, Mamani-Cori V, Caballero-Apaza LM, Cruzado-Oliva FH, Farje-Gallardo CA, Marroquin-Soto C, Aguirre-Ipenza R, Vasquez-Rodrigo H, Lujan-Valencia SA, Meza-Malaga JM, Castillo-Cornock TB, Coronel-Zubiate FT. Effect of minimal intervention on carious lesions in primary teeth. An Umbrella review. Front Dent Med. 2026 Jan 12;6:1751752. doi: 10.3389/fdmed.2025.1751752. eCollection 2025.
PubMed 41602568Mascarenhas AK. Is fluoride varnish safe?: Validating the safety of fluoride varnish. J Am Dent Assoc. 2021 May;152(5):364-368. doi: 10.1016/j.adaj.2021.01.013. Epub 2021 Mar 22.
PubMed 33766405Magalhaes GAP, Fraga MAA, de Souza Araujo IJ, Pacheco RR, Correr AB, Puppin-Rontani RM. Effect of a Self-Assembly Peptide on Surface Roughness and Hardness of Bleached Enamel. J Funct Biomater. 2022 Jun 13;13(2):79. doi: 10.3390/jfb13020079.
PubMed 35735934Kobeissi R, Badr SB, Osman E. Effectiveness of Self-assembling Peptide P11-4 Compared to Tricalcium Phosphate Fluoride Varnish in Remineralization of White Spot Lesions: A Clinical Randomized Trial. Int J Clin Pediatr Dent. 2020 Sep-Oct;13(5):451-456. doi: 10.5005/jp-journals-10005-1804.
PubMed 33623327Diefenderfer KE, Stahl J. Caries remineralization therapy: implications for dental readiness. Mil Med. 2008 Jan;173(1 Suppl):48-50. doi: 10.7205/milmed.173.supplement_1.48.
PubMed 18277722Dawasaz AA, Togoo RA, Mahmood Z, Azlina A, Thirumulu Ponnuraj K. Effectiveness of Self-Assembling Peptide (P11-4) in Dental Hard Tissue Conditions: A Comprehensive Review. Polymers (Basel). 2022 Feb 18;14(4):792. doi: 10.3390/polym14040792.
PubMed 35215706Daruich PM, Brizuela M. Remineralization of Initial Carious Lesions. 2023 Apr 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK573067/
PubMed 34424640Danisman H, Delikan E, Orhan K. Evaluation of the efficacy of P11-4 and CCP-ACPF in the prevention and treatment of white spot lesions: a multi-technique approach. Sci Rep. 2025 Apr 3;15(1):11512. doi: 10.1038/s41598-025-95781-6.
PubMed 40181020Alkilzy M, Tarabaih A, Santamaria RM, Splieth CH. Self-assembling Peptide P11-4 and Fluoride for Regenerating Enamel. J Dent Res. 2018 Feb;97(2):148-154. doi: 10.1177/0022034517730531. Epub 2017 Sep 11.
PubMed 28892645
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can SAP P11-4 Increase The Radiopacity of Incipient Interproximal Carious Lesions on a Radiograph in a Military Population
- ClinicalTrials.gov ID
- NCT07829328
- Acronym / sponsor ID
- SAPP114
- Conditions
- Incipient Interproximal Caries
- Keywords
- Self-assembling peptide, remineralization, caries, incipient caries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tripler Army Medical CenterUS federal agency
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Curodont Repair Fluoride Plus Treatment Group | Experimental | Drug: 0.05% Sodium Fluoride with Self-Assembling PeptidesParticipants 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- non-active duty military
- interproximal carious lesions that are cavitated or D2-D3 in radiographic depth
- tobacco, nicotine, and e-cigarette use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.05% Sodium Fluoride with Self-Assembling PeptidesSingle 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. | Drug | Curodont Repair Fluoride Plus Treatment Group |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 35645534Thakur S, Sojan M, Singhal P, Chauhan D. A Comparative Study to Evaluate the Effectiveness of Silver Diamine Fluoride at Different Time Durations of Application in Treating Carious Primary Teeth: A Randomized Trial. Int J Clin Pediatr Dent. 2022;15(Suppl 2):S147-S150. doi: 10.5005/jp-journals-10005-2326.
- Background: PubMed 30457948Sleibi A, Tappuni A, Mills D, Davis GR, Baysan A. Comparison of the Efficacy of Different Fluoride Varnishes on Dentin Remineralization During a Critical pH Exposure Using Quantitative X-Ray Microtomography. Oper Dent. 2018 Nov/Dec;43(6):E308-E316. doi: 10.2341/18-014-L.
- Background: PubMed 39037455Shaalan O, Fawzy El-Sayed K, Abouauf E. Evaluation of the remineralization potential of self-assembling peptide P11-4 with fluoride compared to fluoride varnish in the management of incipient carious lesions: a randomized controlled clinical trial. Clin Oral Investig. 2024 Jul 22;28(8):438. doi: 10.1007/s00784-024-05822-z.
- Background: PubMed 1521308Pitts NB, Rimmer PA. An in vivo comparison of radiographic and directly assessed clinical caries status of posterior approximal surfaces in primary and permanent teeth. Caries Res. 1992;26(2):146-52. doi: 10.1159/000261500.
- Background: PubMed 41602568Padilla-Caceres TC, Arbildo-Vega HI, Mamani-Cori V, Caballero-Apaza LM, Cruzado-Oliva FH, Farje-Gallardo CA, Marroquin-Soto C, Aguirre-Ipenza R, Vasquez-Rodrigo H, Lujan-Valencia SA, Meza-Malaga JM, Castillo-Cornock TB, Coronel-Zubiate FT. Effect of minimal intervention on carious lesions in primary teeth. An Umbrella review. Front Dent Med. 2026 Jan 12;6:1751752. doi: 10.3389/fdmed.2025.1751752. eCollection 2025.
- Background: PubMed 33766405Mascarenhas AK. Is fluoride varnish safe?: Validating the safety of fluoride varnish. J Am Dent Assoc. 2021 May;152(5):364-368. doi: 10.1016/j.adaj.2021.01.013. Epub 2021 Mar 22.
- Background: PubMed 35735934Magalhaes GAP, Fraga MAA, de Souza Araujo IJ, Pacheco RR, Correr AB, Puppin-Rontani RM. Effect of a Self-Assembly Peptide on Surface Roughness and Hardness of Bleached Enamel. J Funct Biomater. 2022 Jun 13;13(2):79. doi: 10.3390/jfb13020079.
- Background: PubMed 33623327Kobeissi R, Badr SB, Osman E. Effectiveness of Self-assembling Peptide P11-4 Compared to Tricalcium Phosphate Fluoride Varnish in Remineralization of White Spot Lesions: A Clinical Randomized Trial. Int J Clin Pediatr Dent. 2020 Sep-Oct;13(5):451-456. doi: 10.5005/jp-journals-10005-1804.
- Background: PubMed 18277722Diefenderfer KE, Stahl J. Caries remineralization therapy: implications for dental readiness. Mil Med. 2008 Jan;173(1 Suppl):48-50. doi: 10.7205/milmed.173.supplement_1.48.
- Background: PubMed 35215706Dawasaz AA, Togoo RA, Mahmood Z, Azlina A, Thirumulu Ponnuraj K. Effectiveness of Self-Assembling Peptide (P11-4) in Dental Hard Tissue Conditions: A Comprehensive Review. Polymers (Basel). 2022 Feb 18;14(4):792. doi: 10.3390/polym14040792.
- Background: PubMed 34424640Daruich PM, Brizuela M. Remineralization of Initial Carious Lesions. 2023 Apr 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK573067/
- Background: PubMed 40181020Danisman H, Delikan E, Orhan K. Evaluation of the efficacy of P11-4 and CCP-ACPF in the prevention and treatment of white spot lesions: a multi-technique approach. Sci Rep. 2025 Apr 3;15(1):11512. doi: 10.1038/s41598-025-95781-6.
- Curodont® Repair Fluoride Plus Product PageLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven Phung, DMD principal investigator
Tripler Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.05% Sodium Fluoride with Self-Assembling Peptides in people with Incipient Interproximal Caries, run by Tripler Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07829328, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.