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Clinical Performance of a Novel Self-cured Resin Composite Compared to a Light-cured Bioactive Resin Composite Restoration in Proximal Cavities of Posterior Teeth

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07457749
Enrollment
50
Registered
2026-03-09
Start date
2026-02-18
Completion date
2028-03-18
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal Cavities of Posterior Teeth

Keywords

clinical performance, self-cured resin composite, bioactive, proximal cavities

Brief summary

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

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.

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.

Sponsors

British University In Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 47 Years
Healthy volunteers
No

Inclusion criteria

1. Subjects between the ages of 18-47 years old 2. Primary caries removal 3. Good or moderate oral hygiene 4. Free of periodontal diseases (probing depth and attachment levels within normal limits/ no furcation involvement/ no mobility) 5. Cooperative patients who agree to keep the scheduled recall appointments for data collection and maintenance

Exclusion criteria

1. Composite or amalgam removal 2. Caries extended to the cemento-enamel junction in Class II caries 3. Grade II or III mobility 4. Considerable periodontal disease without treatment 5. Endodontically treated teeth with extensive loss of tooth tissues 6. Severe wear facets and/or parafunctional activities as clenching or nocturnal bruxism. 7. Subjects who are pregnant during the duration of the study 8. Subjects with high caries activity

Design outcomes

Primary

MeasureTime frameDescription
Proximal contact tightness of examined class II restorationsBaseline (after 1 week) and at 6, 12, 18, 24 monthsThis primary outcome will be measured using the FDI criteria for direct and indirect restorations

Secondary

MeasureTime frameDescription
Postoperative HypersensitivityImmediate post procedure and after 1 weekOne-week post-operative hypersensitivity will be examined using a visual analogue scale following the FDI criteria (absence/presence of hypersensitivity).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026