Dental CariesREMİN-PRİMARYNCT07431463
Effects of Different Remineralization Agents on the Progression of Non-Cavitated Approximal Carious Lesions in Primary Teeth: A Randomized Clinical Trial
A study testing P11-4 + NaF Varnish, Silver diamine fluoride and NaF Varnish Alone in people with Dental Caries, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Dental caries is a highly prevalent disease in children. Contemporary caries management emphasizes minimally invasive approaches that aim to arrest or reverse non-cavitated lesions rather than remove tooth structure. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- P11-4 + NaF Varnish, Silver diamine fluoride and NaF Varnish Alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 30 Dec 2026
- Phase
- Interventional
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4-10 years
- Presence of at least two non-cavitated proximal caries lesions in primary teeth
- Radiographic detection of lesions classified as E1, E2, or D1
- Absence of systemic disease
- Cooperative patients
- Written informed consent obtained from parents or legal guardians
Who cannot join
- Presence of restorations on study teeth
- Deep dentin caries (D2 or D3)
- Cavitated lesions
- Uncooperative patients
- Inability to attend follow-up visits
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Katip Çelebi University Faculty of Dentistry
Izmir, İzmir, 35640
About this study
Dental caries is a highly prevalent disease in children. Contemporary caries management emphasizes minimally invasive approaches that aim to arrest or reverse non-cavitated lesions rather than remove tooth structure. This randomized clinical trial aims to evaluate the effects of different remineralization agents on the progression of non-cavitated approximal carious lesions in primary teeth.
The study will be conducted in children aged 4-10 years presenting with non-cavitated approximal carious lesions in primary molars. Participants will be randomly assigned to treatment groups receiving silver diamine fluoride (SDF), a self-assembling peptide (P11-4), and/or 5% sodium fluoride (NaF) varnish. Materials will be applied according to manufacturers' instructions.
Read more
Lesion progression will be assessed using standardized bitewing radiographs obtained at baseline and follow-up visits. Radiographic evaluations will be performed by blinded investigators. In addition, potential tooth color changes associated with the treatments will be quantitatively measured using a spectrophotometer based on the CIE Lab* system at predefined follow-up intervals.
The findings of this study are expected to provide clinically relevant evidence regarding the effectiveness and aesthetic outcomes of contemporary non-invasive caries management strategies in primary teeth.
Read the detailed description
This study is designed as a randomized, parallel-group clinical trial investigating the effects of different remineralization agents on non-cavitated approximal carious lesions in primary teeth.
The study population will consist of children aged 4-10 years with at least two non-cavitated approximal carious lesions (radiographically classified at the enamel or outer dentin level) in primary molars. After baseline clinical and radiographic examinations, eligible teeth will receive preventive treatment interventions.
Participants will be randomly allocated to treatment groups. Interventions include silver diamine fluoride (SDF), a self-assembling peptide (P11-4), and 5% sodium fluoride (NaF) varnish. All materials will be applied following manufacturers' recommendations and standard clinical procedures. Repeat applications will be performed at scheduled follow-up visits.
Lesion progression will be evaluated using standardized bitewing radiographs taken at baseline and follow-up periods. Radiographic assessments will be performed independently by blinded examiners using predefined scoring criteria. Changes in lesion status over time will be categorized as regression, stability, or progression.
To assess potential aesthetic effects of the treatments, tooth color measurements will be performed using a spectrophotometer under standardized conditions. Color parameters will be recorded according to the CIE Lab* color system at baseline and follow-up visits.
Statistical analyses will be conducted to evaluate differences in lesion progression and color changes between treatment groups. Reliability of radiographic assessments will be evaluated using appropriate agreement statistics.
This study aims to generate clinical evidence regarding the effectiveness of minimally invasive remineralization strategies for managing non-cavitated approximal carious lesions in primary teeth.
- Conditions
- Dental Caries
- Being tested
- P11-4 + NaF Varnish, Silver diamine fluoride, NaF Varnish Alone
- Keywords
- Primary Teeth, Non-cavitated Carious Lesions, Approximal Caries, Remineralization Agents, Randomized Clinical Trial
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P11-4 + NaF VarnishOther
Topically apply the self-assembling peptide P11-4 (Curodont Repair, Vardis, Switzerland) to non-cavitated approximal carious lesions in primary teeth, followed by 5% sodium fluoride varnish (Profluorid Varnish, VOCO, Germany).
Silver diamine fluorideOther
Topical application of silver diamine fluoride (Riva Star, SDI, Victoria, Australia) to non-cavitated approximal carious lesions in primary teeth.
NaF Varnish AloneOther
Topical application of 5% sodium fluoride varnish (Profluorid Varnish, VOCO, Germany) was used on non-cavitated approximal carious lesions in primary teeth.
| Study group | Role | What they receive |
|---|---|---|
| P11-4 + NaF Varnish | Experimental | Approximal carious lesions in primary teeth that were non-cavitated were treated with the self-assembling peptide P11-4, followed by 5% sodium fluoride varnish, using a randomized split-mouth design. Receives: Other: P11-4 + NaF Varnish |
| Silver Diamine Fluoride | Experimental | This study examined the treatment of non-cavitated approximal carious lesions in primary teeth with silver diamine fluoride using a randomized split-mouth design. Receives: Other: Silver diamine fluoride |
| NaF Varnish Alone | Active comparator | Approximal carious lesions in primary teeth that were non-cavitated were treated with 5% sodium fluoride varnish alone in a randomized split-mouth design. Receives: Other: NaF Varnish Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic progression of approximal caries lesions
Lesion progression will be assessed using standardized bitewing radiographs and evaluated according to the E0-E2, D1-D3 radiographic scoring system. Changes in lesion status over time will be categorized as regression, stability, or progression based on predefined radiographic criteria.
Measured: 6 months and 12 months after intervention
Secondary outcomes (2)
Tooth color change (ΔE)
Color changes will be measured using a spectrophotometer based on the CIE Lab* system. ΔE values will be calculated between baseline and follow-up visits to quantify treatment-related discoloration.
Measured: 3 months, 6 months, and 12 months
Clinical lesion activity
Lesion activity will be assessed using a visual-tactile clinical examination according to predefined clinical activity criteria (active / inactive).
Measured: 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Oct 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized split-mouth clinical trial in which different remineralization agents are applied to non-cavitated approximal carious lesions in the same participants. This allows for an intra-individual comparison of the effects of the treatments.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve AKCAY, Izmir Katip Celebi University
- Investigators
- Merve Akçay, Prof. Dr., Study chair, Izmir Katip Çelebi University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431463
- Sponsor's protocol ID
- 2024-KAE-0126
- Other IDs
- 2025-TDR-DİŞF-0004
- Acronym
- REMİN-PRİMARY
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to institutional policies and ethical considerations regarding pediatric patient confidentiality, individual participant data (IPD) will not be shared.
Publications
Anusavice KJ. Present and future approaches for the control of caries. J Dent Educ. 2005 May;69(5):538-54.
PubMed 15897335
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Remineralization Agents on the Progression of Non-Cavitated Approximal Carious Lesions in Primary Teeth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07431463
- Acronym / sponsor ID
- REMİN-PRİMARY / 2024-KAE-0126
- Conditions
- Dental Caries
- Keywords
- Primary Teeth, Non-cavitated Carious Lesions, Approximal Caries, Remineralization Agents, Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 Feb 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.
Dental caries is a highly prevalent disease in children. Contemporary caries management emphasizes minimally invasive approaches that aim to arrest or reverse non-cavitated lesions rather than remove tooth structure. This randomized clinical trial aims to evaluate the effects of different remineralization agents on the progression of non-cavitated approximal carious lesions in primary teeth.
The study will be conducted in children aged 4-10 years presenting with non-cavitated approximal carious lesions in primary molars. Participants will be randomly assigned to treatment groups receiving silver diamine fluoride (SDF), a self-assembling peptide (P11-4), and/or 5% sodium fluoride (NaF) varnish. Materials will be applied according to manufacturers' instructions.
Lesion progression will be assessed using standardized bitewing radiographs obtained at baseline and follow-up visits. Radiographic evaluations will be performed by blinded investigators. In addition, potential tooth color changes associated with the treatments will be quantitatively measured using a spectrophotometer based on the CIE Lab* system at predefined follow-up intervals.
The findings of this study are expected to provide clinically relevant evidence regarding the effectiveness and aesthetic outcomes of contemporary non-invasive caries management strategies in primary teeth.
Detailed description
This study is designed as a randomized, parallel-group clinical trial investigating the effects of different remineralization agents on non-cavitated approximal carious lesions in primary teeth.
The study population will consist of children aged 4-10 years with at least two non-cavitated approximal carious lesions (radiographically classified at the enamel or outer dentin level) in primary molars. After baseline clinical and radiographic examinations, eligible teeth will receive preventive treatment interventions.
Participants will be randomly allocated to treatment groups. Interventions include silver diamine fluoride (SDF), a self-assembling peptide (P11-4), and 5% sodium fluoride (NaF) varnish. All materials will be applied following manufacturers' recommendations and standard clinical procedures. Repeat applications will be performed at scheduled follow-up visits.
Lesion progression will be evaluated using standardized bitewing radiographs taken at baseline and follow-up periods. Radiographic assessments will be performed independently by blinded examiners using predefined scoring criteria. Changes in lesion status over time will be categorized as regression, stability, or progression.
To assess potential aesthetic effects of the treatments, tooth color measurements will be performed using a spectrophotometer under standardized conditions. Color parameters will be recorded according to the CIE Lab* color system at baseline and follow-up visits.
Statistical analyses will be conducted to evaluate differences in lesion progression and color changes between treatment groups. Reliability of radiographic assessments will be evaluated using appropriate agreement statistics.
This study aims to generate clinical evidence regarding the effectiveness of minimally invasive remineralization strategies for managing non-cavitated approximal carious lesions in primary teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a randomized split-mouth clinical trial in which different remineralization agents are applied to non-cavitated approximal carious lesions in the same participants. This allows for an intra-individual comparison of the effects of the treatments.
| Arm | Type | Receives |
|---|---|---|
| P11-4 + NaF Varnish | Experimental | Other: P11-4 + NaF VarnishApproximal carious lesions in primary teeth that were non-cavitated were treated with the self-assembling peptide P11-4, followed by 5% sodium fluoride varnish, using a randomized split-mouth design. |
| Silver Diamine Fluoride | Experimental | Other: Silver diamine fluorideThis study examined the treatment of non-cavitated approximal carious lesions in primary teeth with silver diamine fluoride using a randomized split-mouth design. |
| NaF Varnish Alone | Active comparator | Other: NaF Varnish AloneApproximal carious lesions in primary teeth that were non-cavitated were treated with 5% sodium fluoride varnish alone in a randomized split-mouth design. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 4-10 years
- Presence of at least two non-cavitated proximal caries lesions in primary teeth
- Radiographic detection of lesions classified as E1, E2, or D1
- Absence of systemic disease
- Cooperative patients
Key exclusion criteria (5 listed)
- Presence of restorations on study teeth
- Deep dentin caries (D2 or D3)
- Cavitated lesions
- Uncooperative patients
- Inability to attend follow-up visits
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 |
|---|---|---|
| P11-4 + NaF VarnishTopically apply the self-assembling peptide P11-4 (Curodont Repair, Vardis, Switzerland) to non-cavitated approximal carious lesions in primary teeth, followed by 5% sodium fluoride varnish (Profluorid Varnish, VOCO, Germany). | Other | P11-4 + NaF Varnish |
| Silver diamine fluorideTopical application of silver diamine fluoride (Riva Star, SDI, Victoria, Australia) to non-cavitated approximal carious lesions in primary teeth. | Other | Silver Diamine Fluoride |
| NaF Varnish AloneTopical application of 5% sodium fluoride varnish (Profluorid Varnish, VOCO, Germany) was used on non-cavitated approximal carious lesions in primary teeth. | Other | NaF Varnish Alone |
Primary outcome
Radiographic progression of approximal caries lesions
Time frame: 6 months and 12 months after intervention
Lesion progression will be assessed using standardized bitewing radiographs and evaluated according to the E0-E2, D1-D3 radiographic scoring system. Changes in lesion status over time will be categorized as regression, stability, or progression based on predefined radiographic criteria.
2 secondary outcomes
Tooth color change (ΔE)
Time frame: 3 months, 6 months, and 12 months
Clinical lesion activity
Time frame: 3 months, 6 months, and 12 months
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 24 Feb 2026.
- Background: PubMed 15897335Anusavice KJ. Present and future approaches for the control of caries. J Dent Educ. 2005 May;69(5):538-54.
- Individual participant dataSharing planned: No. Due to institutional policies and ethical considerations regarding pediatric patient confidentiality, individual participant data (IPD) will not be shared.
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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. This study is not recruiting at the moment.
Merve Akçay, Prof. Dr. study chair
Izmir Katip Çelebi University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P11-4 + NaF Varnish, Silver diamine fluoride and NaF Varnish Alone in people with Dental Caries, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Feb 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 Turkey (Türkiye). 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.
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?
Radiographic progression of approximal caries lesions (time frame: 6 months and 12 months after intervention). 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 NCT07431463, which also lists 1 linked publication.
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 24 Feb 2026.