Clinical Performance of a Novel Self-cured Resin Composite Compared to a Light-cured Bioactive Resin Composite Restoration in Proximal Cavities of Posterior Teeth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stela, SDI, Australia, Beautifil II, Shofu, Japan.
- Who it may be relevant to
- Registry conditions: Proximal Cavities of Posterior Teeth. Basic parameters: 18 years — 47 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Performance of a Novel Self-cured Resin Composite Compared to a Light-cured Bioactive Resin Composite Restoration in Proximal Cavities of Posterior Teeth: A 2-year Randomized Controlled Clinical Trial
Overview
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.
Interventions
- Drug Stela, SDI, Australia
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. - Drug Beautifil II, Shofu, Japan
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.
Primary outcome measures
- Proximal contact tightness of examined class II restorations [Time frame: Baseline (after 1 week) and at 6, 12, 18, 24 months]
Secondary outcome measures (1)
- Postoperative Hypersensitivity [Time frame: Immediate post procedure and after 1 week]
Eligibility criteria
Inclusion criteria
- 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)
- Cooperative patients who agree to keep the scheduled recall appointments for data collection and maintenance
Exclusion criteria
- 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
- Endodontically treated teeth with extensive loss of tooth tissues
- Severe wear facets and/or parafunctional activities as clenching or nocturnal bruxism.
- Subjects who are pregnant during the duration of the study
- Subjects with high caries activity
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dentistry, The British University in Egypt — Cairo
Identifiers
NCT: NCT07457749 · 25-069 · Self-funded