Initial Dental Caries
Conditions
Keywords
Remineralization, Nano eggshell, initial enamel caries
Brief summary
This randomized controlled clinical trial aims to evaluate and compare the remineralizing effect of nano-eggshell varnish, CPP-ACP paste (GC Tooth Mousse), and sodium fluoride varnish on initial enamel caries among adolescents aged 15-20 years. Participants will be randomly allocated into three groups. Remineralization and caries activity will be assessed using DIAGNOdent readings, International Caries Classification and Management System (ICCMS) criteria, and the decayed, missed, and filled surfaces (DMFS) index over a 12-month follow-up period.
Interventions
DRUGnano-eggshell varnish
Nano-eggshell varnish is applied topically to tooth surfaces every 3 months, according to manufacturer instructions, to promote the remineralization of initial enamel caries.
DRUGCasein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP)Dental Paste
Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) paste was applied daily by participants after tooth brushing at bedtime and left on teeth for at least 3 minutes before rinsing.
5% sodium fluoride varnish is applied topically every 3 months according to manufacturer instructions as a controlled remineralizing agent.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Masking will be applied at the level of the outcome assessor. The examiner responsible for evaluating caries activity and remineralization outcomes (using DIAGNOdent and ICCMS criteria) will be blinded to group allocation. Participants and operators cannot be blinded due to the different nature of the interventions.
Intervention model description
Participants will be randomly assigned into three parallel groups. Each group will receive a different intervention: nano-eggshell varnish, sodium fluoride varnish (5%), or GC Tooth Mousse. The interventions will be applied according to the study protocol, and participants will be followed for 12 months to assess remineralization outcomes.
Eligibility
Sex/Gender
ALL
Age
15 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
Patients' ages should be 15-20 years. Patients should have at least three to four teeth with ICDAS II scores of 1-2. Patients should have moderate-to-high caries risk.
Exclusion criteria
Known hypersensitivity to one of the components of the material under study. Systemic disorders or medication interfering with normal salivary flow.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in remineralization of initial enamel caries | Baseline to 12 months | Change in remineralization of initial enamel caries measured by DIAGNOdent readings from baseline to 12 months. When the DIAGNOdent reading decreases, it means good remineralization ability. |
| Change in DIAGNOdent readings | Baseline, 3, 6, 9, and 12 months | The DIAGNOdent device will be used to quantify changes in enamel demineralization and remineralization over time. Measurements will be recorded at different follow-up intervals |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caries activity assessment using ICCMS criteria | Baseline, 3, 6, 9, and 12 months | Caries activity will be assessed using the International Caries Classification and Management System (ICCMS) criteria. Lesions will be classified as active or inactive based on surface texture, appearance, and plaque stagnation area |
| Change in the Decayed, Missing, and Filled Surfaces (DMFS) index | baseline, after 6 and 12 months | Dental caries experience will be evaluated using the Decayed, Missing, and Filled Surfaces (DMFS) index at baseline and after 6 and 12 months to assess overall changes in caries experience. |
Countries
Egypt
Contacts
CONTACTGhada E Elhindawy
Outcome results
None listed