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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-47
SponsorBritish University In Egypt

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Beautifil II , Shofu (Light-cured Resin Composite)Active comparator 1 intervention
Group B: Stela, SDI, Australia (Self-cured Resin Composite)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proximal contact tightness of examined class II restorations

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

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

Secondary outcomes

1

Postoperative Hypersensitivity

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

Time frame
Immediate post procedure and after 1 week

Other outcomes

Sponsors and contacts

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