Clinical Performance of Bioactive Restorative Materials

Condition(s) studied

Investigational drug(s) / intervention(s)

Tetric N Ceram Bulkfill application: Selective enamel etching was performed with 37% phosphoric acid followed by a universal adhesive system application to all cavity surfaces and LED cured. The bulk-fill composite resin was placed in a single increment according to the manufacturer's recommendations and light-cured for 20 seconds. Excess material was removed using flame-shaped diamond finishing burs. Occlusion was assessed with articulation paper, and premature or undesirable contact points were adjusted as necessary.

Cention Forte application: A drop of Cention Primer was mixed in its wheel for 5 seconds and actively applied to the cavity for 10 seconds, followed by gentle air-drying. The Cention Forte capsule was then mixed for 15 seconds in a capsule mixer and placed in bulk into the prepared cavity using the manufacturer's delivery gun. Light curing was performed for 20 seconds with an LED unit (1300 mW/cm²; ZenoLite, President, Germany). Excess material was removed using flame-shaped diamond finishing burs. Occlusion was assessed with articulation paper, and any premature or undesirable contact points were adjusted accordingly. Final polishing was performed with OptraGloss polishing wheels (Ivoclar Vivadent) for 20 seconds.

Stela Automix: Stela Primer was applied to the cavity surfaces and margins for 10 seconds. After a 5-second waiting period, the primer was gently air-dried for 2-3 seconds. The Stela Automix injector tip was then angled as needed and inserted into the cavity to deliver the material. The restoration was allowed to self-cure for 4 minutes. Occlusion was evaluated using articulation paper, and any premature or undesired contact points were adjusted as necessary. Final polishing was performed with OptraGloss polishing wheels (Ivoclar Vivadent) for 20 seconds.

Activa BioActive Restorative: Selective enamel etching was performed with 37% phosphoric acid for 15 seconds, followed by thorough rinsing and air-drying. A universal adhesive system (Tetric N-Bond Universal, Ivoclar Vivadent) was applied to all cavity surfaces, including enamel, for 20 seconds, air-thinned, and light-cured for 20 seconds using an LED unit (1300 mW/cm²; ZenoLite, President, Germany). Following the manufacturer's instructions, the placement tip was inserted into the cavity using the dedicated placement gun, and the material was delivered in bulk. Light curing was performed for 20 seconds. Excess material was removed using flame-shaped diamond finishing burs. Occlusion was assessed with articulation paper, and premature or undesirable contact points were adjusted as needed. Final polishing was performed with OptraGloss polishing wheels (Ivoclar Vivadent) for 20 seconds.

Study summary

The aim of this clinical study is to evaluate the performance of three different bioactive restorative materials against a composite resin for a period of 9 months.

This randomized, split-mouth, single-center trial was performed on patients having occlusal caries (ICDAS 3 and 4) in both molars of the same jaw. The restorative materials used were Tetric N-Ceram Bulk-fill (control, Ivoclar Vivadent, Liechtenstein), Stela (SDI, Australia), Cention Forte (Ivoclar) and Activa BioActive Restorative (Pulpdent, USA). The restorations were evaluated at baseline, 3-6 and 9-month according to FDI-2 criteria, in terms of functional, biological, and aesthetic parameters, by two experienced evaluators.

Eligibility

Primary outcome measure(s)

• FDI-2 evaluation criteria for functional properties — 2 years
  Clinical evaluations were conducted using the FDI-2 criteria by two experienced, calibrated, and blinded evaluators for functional properties (category F). fracture/displacement of the material, marginal adaptation, form and contour, occlusion, and wear) were scored. Scores of 1-3 indicate clinically acceptable and successful restorations, score 4 indicates clinically inadequate but repairable defects, and score 5 represents clinically unacceptable restorations.

Trial sites (1)

More Ege University trials in Turkey

Other trials for the same condition