Dental Caries
Conditions
Keywords
Primary Teeth, Non-cavitated Carious Lesions, Approximal Caries, Remineralization Agents, Randomized Clinical Trial
Brief 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. 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.
Interventions
OTHERP11-4 + NaF Varnish
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).
OTHERSilver diamine fluoride
Topical application of silver diamine fluoride (Riva Star, SDI, Victoria, Australia) to non-cavitated approximal carious lesions in primary teeth.
OTHERNaF Varnish Alone
Topical application of 5% sodium fluoride varnish (Profluorid Varnish, VOCO, Germany) was used on non-cavitated approximal carious lesions in primary teeth.
Sponsors
Izmir Katip Celebi University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
In this split-mouth randomized clinical trial, the outcome assessor was blinded to the lesions' allocation to remineralization agents.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Presence of restorations on study teeth * Deep dentin caries (D2 or D3) * Cavitated lesions * Uncooperative patients * Inability to attend follow-up visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic progression of approximal caries lesions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tooth color change (ΔE) | 3 months, 6 months, and 12 months | 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. |
| Clinical lesion activity | 3 months, 6 months, and 12 months | Lesion activity will be assessed using a visual-tactile clinical examination according to predefined clinical activity criteria (active / inactive). |
Countries
Turkey (Türkiye)
Contacts
STUDY_CHAIRMerve Akçay, Prof. Dr.
Izmir Katip Çelebi University Faculty of Dentistry
Outcome results
None listed