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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nano-eggshell varnish group 1 | Experimental | Nano-eggshell varnish will be professionally applied to the teeth surfaces every 3 months according to the manufacturer's instructions. Participants will be instructed to avoid eating or drinking for at least 30 minutes after application. |
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| Casein phosphopeptide amorphous calcium phosphate (CPP-ACP) as GC tooth mousse group 2 | Experimental | Participants will be instructed to apply CPP-ACP (GC tooth mousse) daily after tooth brushing at bedtime. The material will be kept on the tooth surfaces for at least 3 minutes before rinsing. |
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| Sodium fluoride varnish (5%) group 3 | Active Comparator | Sodium fluoride varnish (5%) will be professionally applied every 3 months according to manufacturer instructions. Participants will be instructed to avoid eating or drinking for at least 30 minutes after application. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nano-eggshell varnish | Drug | Nano-eggshell varnish is applied topically to tooth surfaces every 3 months, according to manufacturer instructions, to promote the remineralization of initial enamel caries. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in remineralization of initial enamel caries | 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. | Baseline to 12 months |
| Change in DIAGNOdent readings | 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 | Baseline, 3, 6, 9, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Caries activity assessment using ICCMS criteria | 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 | Baseline, 3, 6, 9, and 12 months |
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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.
Both male and female participants will be included in this study with equal distribution between genders.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ghada E Elhindawy | Contact | 00201102668577 | ghada.ezzat91@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Mansoura University | Recruiting | Al Mansurah | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Sarhan M, El Baz M, Hamza O. Remineralization effect of eggshell powder on post-orthodontic white spot lesions compared to CPP-ACP: a randomized controlled clinical trial. Egyptian Dental Journal. 2021. 67(3): 2701-2710. |
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Data available upon request
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 4, 2024 |
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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.
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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.
| Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP)Dental Paste | Drug | 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. |
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| Sodium Fluoride Varnish (5%) | Drug | 5% sodium fluoride varnish is applied topically every 3 months according to manufacturer instructions as a controlled remineralizing agent. |
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| Change in the Decayed, Missing, and Filled Surfaces (DMFS) index |
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. |
| baseline, after 6 and 12 months |
| Jul 9, 2026 |
| Prot_SAP_000.pdf |