Clinical Trial

A Two-year Study Evaluating the Surface-sealed Cervical Resin Composite Restorations in Comparison With the Non-sealed Restorations

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Summary
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®.
Protocol Amendment History 1 change
notable Primary completion pushed: 2028-05 -> 2028-07 2026-06-06
Trial Details
NCT Number NCT07618013
Lead Sponsor Cairo University
Conditions Marginal Discoloration, Color Stability
Enrollment 25 participants
Start Date 2026-07
Primary Completion 2028-07 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-06-05