About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects between the ages of 18-47 years old
Primary caries removal
Good or moderate oral hygiene
Free of periodontal diseases (probing depth and attachment levels within normal limits/ no furcation involvement/ no mobility)
Disqualifiers
Composite or amalgam removal
Caries extended to the cemento-enamel junction in Class II caries
Grade II or III mobility
Considerable periodontal disease without treatment
Trial design
Parallel
Treatments tested in this trial
Stela, SDI, Australia
DrugStela, (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.
Beautifil II, Shofu, Japan
DrugBeautifil 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.
Treatment groups
Trial outcomes
Primary outcomes
Proximal contact tightness of examined class II restorations
This primary outcome will be measured using the FDI criteria for direct and indirect restorations
Secondary outcomes
Postoperative Hypersensitivity
One-week post-operative hypersensitivity will be examined using a visual analogue scale following the FDI criteria (absence/presence of hypersensitivity).
Sponsors and contacts
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