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After finishing and polishing are completed, the tooth surface may exhibit microcracks and micro-irregularities that create a roughened surface, which may lead to plaque retention, gingival inflammation, and discoloration. The surface-penetrating sealant was introduced to fill micro-irregularities by capillary action, providing a uniform, regular surface and enhancing the surface smoothness. The application of unfilled low-viscosity surface sealants aims to enhance the luster, smoothness, and color stability of esthetic restorations and decrease stain absorption. They have low viscosity that enables them to easily spread and penetrate over these finished and polished surfaces, which may affect the life of the restoration positively. Additionally, it decreases surface porosity and creates a surface that is more thoroughly cured, improving the composite's stain resistance.
This prospective, parallel-group, randomized clinical study aims to compare the clinical effectiveness of using surface sealants on cervical resin composite restorations versus non-sealed restorations. Restorations will be assessed at baseline, 6, 12, 18, and 24 months using modified USPHS criteria. The primary outcome will be assessing marginal discoloration, and the secondary outcomes will be assessing color match, secondary caries, postoperative sensitivity, surface texture, and marginal adaptation. Color stability will be assessed by VITA Easyshade®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unfilled resin surface sealant group | Experimental | Patients with carious cervical lesions (class V) in the esthetic zone receiving resin composite restorations covered by the Unfilled resin surface sealant |
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| Nano-filled resin surface sealant group | Experimental | Patients with carious cervical lesions (class V) in the esthetic zone receiving resin composite restorations covered by the Nano-filled resin surface sealant |
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| Class V Restorations without resin surface sealants. | Active Comparator | Patients with carious cervical lesions (class V) in the esthetic zone receiving resin composite restorations not covered by the resin surface sealant |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PermaSeal™, Ultradent Products Inc., USA | Other | Unfilled resin surface sealant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Marginal discoloration | Modified USPHS criteria | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Color match, Secondary caries, Postoperative sensitivity, Surface texture , Marginal adaptation | Modified USPHS criteria | 2 years |
| Color stability | by VITA Easyshade® |
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Participant Inclusion Criteria:
Teeth inclusion criteria:
Participant Exclusion Criteria:
Teeth Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nanees Ayman Hassan Aly | Contact | 01210974750 | nanees.ayman@dentistry.cu.edu.eg |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | • Amin, A. H., Yaakob, M. H., Nasir, W. Z. W., & Al-Kadhim, A. H. A. (2018). Evaluation the correlation between age, gender, and the incidence of cervical lesions. Journal of Clinical Research in Dentistry, 1(1). • Attia, R. M., Sobhy, E. M., & Abd El Hameed, M. E. S. (2023). Micro-Hardness and Surface Roughness of Bulk-Fill Composite Resin: Effect of Surface Sealant Application and Two Bleaching Regimens. European Journal of General Dentistry, 12(03), 169-176. • Calazans, F. S., Ferreira, T. D. M. J., Ñaupari-Villasante, R., Mendonça, R. P., Ornellas, G., Albuquerque, E. G., ... & Loguercio, A. D. (2024). Influence of surface sealants on the quality of posterior restorations with bulk-fill composites: A 4-year randomized clinical trial. Dental Materials, 40(3), 466-476. • Dawoud, B., Abou-Auf, E., & Shaalan, O. (2025). 24-Month clinical evaluation of cervical restorations bonded using radio-opaque universal adhesive compared to conventional universal adhesive in carious cervical lesions: A randomized clinical trial. Scientific Reports, 15(1), 5505. • Demarco, F. F., Collares, K., Coelho-de-Souza, F. H., Correa, M. B., Cenci, M. S., Moraes, R. R., & Opdam, N. J. (2015). Anterior composite restorations: A systematic review on long-term survival and reasons for failure. Dental materials, 31(10), 1214-1224. • de Melo Soares, V., de Oliveira Bomfim, H. L. Q., Romão, D. A., de Moraes Porto, I. C. C., & de Mendonça Fragoso, L. S. (2024). Comparative Analysis of Different Methods of Marginal Microleakage Evaluation for Restored Teeth by Composite Resin. Journal of Health Sciences, 26(4), 221-225. • Elwassefy, N., ElEmbaby, A., & Elkholany, N. (2023). Correlation between surface roughness and color stability of nano-and micro-hybrid resin composites using different surface treatment protocols. Egyptian Dental Journal, 69(1), 705-713. |
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The decision regarding sharing of individual participant data (IPD) has not yet been finalized.
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| OPTIGLAZE™, GC, Tokyo, Japan | Other | Unfilled resin surface sealant |
|
| Conventional finishing and polishing protocol | Other | Restorations without resin surface sealants. |
|
| 2 years |
| ID | Term |
|---|---|
| C000618652 | PermaSeal |
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