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NCT Number: NCT07457749

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

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.

Recruiting

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Key information

Age range

18 year–47 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Faculty of Dentistry, The British University in Egypt

Cairo, El Sherouk City, 11837, Egypt

Location status: Recruiting

Location contact

Dalia Ghalwash Profressor Dr.

CONTACT

[email protected]

+20 19283

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Proximal contact tightness of examined class II restorations

    Time frame: Baseline (after 1 week) and at 6, 12, 18, 24 months

    This primary outcome will be measured using the FDI criteria for direct and indirect restorations

Secondary outcomes

  1. Postoperative Hypersensitivity

    Time frame: Immediate post procedure and after 1 week

    One-week post-operative hypersensitivity will be examined using a visual analogue scale following the FDI criteria (absence/presence of hypersensitivity).

Sponsors and collaborators

Lead sponsor

British University In Egypt

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 9, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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