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| ID | Type | Description | Link |
|---|---|---|---|
| Self-funded | Other Identifier | The British University in Egypt |
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The development of dental caries is multi-factorial mainly due to the presence of 4 elements which are: dental biofilm, fermentable carbohydrates , dental hard tissue and time. Other additional social and environmental factors can have a substantial impact on the onset and course of the disease. Dietary habits, oral hygiene, salivary flow and fluoride exposure are key factors that influence the susceptibility to dental caries. If dental caries is properly managed, it is a preventable and reversible disease. The proximal teeth surfaces are the most susceptible sites for demineralization from the acidic byproducts. In modern restorative dentistry, clinicians always seek solutions that streamline procedures, improve outcomes and reduce chair time for patients. Traditional light-cured composite systems often involve a complex seven step process which includes etching, priming, bonding and curing which consumes from 90 to 120 seconds to be completed. With each additional step, the risk of technique errors increases, potentially compromising the longevity of the restoration. Self-cure composites, with their simplified application process, are emerging as a preferred choice over the traditional seven-step composite materials. Recently, a novel self-cured high-performance bulk-fill restorative material has been introduced into the market (Stela, SDI, Victoria, Australia). It's particularly known for its "unlimited" depth of cure and self-adhesive properties.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beautifil II , Shofu (Light-cured Resin Composite) | Active Comparator | It is a light-cured bioactive nanohybrid resin composite restorative material |
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| Stela, SDI, Australia (Self-cured Resin Composite) | Experimental | It is a novel self-cured bulk-fill restorative material. It is offered in two application forms (Stela Automix & Stela Capsule) that is used in combination with a proprietary adhesive primer (Stela Primer), which does not require light curing, but it undergoes polymerization upon contact with the restorative material in addition to its ability to generate minimal shrinkage stresses. The polymerization starting at the bottom of the cavity helps drastically reduce polymerization shrinkage stress, which is a common cause of post-operative sensitivity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stela, SDI, Australia | Drug | Stela, (SDI ) is a novel self-cured bulkfill dental restorative material that is used in combination with an adhesive primer (Stela primer) which doesn't require light curing but it undergoes polymerization upon contact with the restorative material. |
| Measure | Description | Time Frame |
|---|---|---|
| Proximal contact tightness of examined class II restorations | This primary outcome will be measured using the FDI criteria for direct and indirect restorations | Baseline (after 1 week) and at 6, 12, 18, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Hypersensitivity | One-week post-operative hypersensitivity will be examined using a visual analogue scale following the FDI criteria (absence/presence of hypersensitivity). | Immediate post procedure and after 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, The British University in Egypt | Recruiting | Cairo | El Sherouk City | 11837 | Egypt |
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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 | Dec 15, 2025 |
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| Beautifil II, Shofu, Japan | Drug | Beautifil II is a light-cured bioactive nanohybrid resin composite restorative material. It is a renowned Giomer (Glass-ionomer/composite hybrid) restorative material from Shofu. It is famous for its "S-PRG" (Surface Pre-Reacted Glass) technology, which allows it to release and recharge fluoride like a glass ionomer while maintaining the aesthetics and durability of a composite. |
|
| Mar 4, 2026 |
| Prot_SAP_000.pdf |