An interventional study of P11-4 + NaF Varnish and Silver diamine fluoride in Dental Caries, sponsored by Izmir Katip Celebi University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 4 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by Izmir Katip Celebi University · Not applicable, Interventional, and Treatment
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.
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.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 90 is above the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Izmir Katip Celebi University is the lead sponsor of 191 studies on the registry; 40 are open to participants now.
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Exclusion Criteria:
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.
Other: P11-4 + NaF Varnish
This study examined the treatment of non-cavitated approximal carious lesions in primary teeth with silver diamine fluoride using a randomized split-mouth design.
Other: Silver diamine fluoride
Approximal carious lesions in primary teeth that were non-cavitated were treated with 5% sodium fluoride varnish alone in a randomized split-mouth design.
Other: NaF Varnish Alone
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).
Topical application of silver diamine fluoride (Riva Star, SDI, Victoria, Australia) to non-cavitated approximal carious lesions in primary teeth.
Topical application of 5% sodium fluoride varnish (Profluorid Varnish, VOCO, Germany) was used on non-cavitated approximal carious lesions in primary teeth.
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.
Time frame: 6 months and 12 months after intervention
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.
Time frame: 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).
Time frame: 3 months, 6 months, and 12 months
Plan to share: No — Due to institutional policies and ethical considerations regarding pediatric patient confidentiality, individual participant data (IPD) will not be shared.
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Izmir Katip Celebi University