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Active, Not Recruiting

NCT Number: NCT07394751

Clinical Performance of Bioactive Restorative Materials

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Dental Caries Dental Adhesive Materials Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

20 year–34 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University School of Dentistry

Izmir, Bornova, 35100, Turkey (Türkiye)

About this study

Objectives: To clinically evaluate the performance of three different bioactive restorative materials against a composite resin for a period of 9 months.

Materials and Methods: 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 material allocation was randomly assigned by a drawing lot. 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. Chi-square test was used to compare the variables in the categories. Mann-Whitney U test and paired T test compared the difference in scores for the groups (p<0.05).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Individuals over the age of 16 with permanent dentition
  • Individuals with a total of four vital molar teeth requiring restoration (ICDAS 3-4), two on each side of the same jaw
  • Individuals with posterior contact with antagonist teeth
  • Individuals who are reliable, cooperative, and willing to participate in periodic follow-ups

Exclusion criteria

  • Individuals whose antagonist teeth were missing or have crowns, bridges, etc.
  • Individuals with history of alcohol, drug, or medication addiction.
  • Individuals with pulp exposure during cavity preparation or a cavity depth exceeding 2-4 mm.
  • Individuals known to be unable to attend follow-up appointments.
  • Individuals with allergies to the products used in the procedure.
  • Individuals with severe tooth grinding or bruxism.
  • Individuals with caries conditions classified as ICDAS 5 and 6.
  • Pregnant or breastfeeding individuals and individuals planning pregnancy during the study.

Treatment and study plan

Tetric N Ceram Bulkfill application

Procedure

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

Procedure

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

Procedure

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

Procedure

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.

Primary outcomes

  1. FDI-2 evaluation criteria for functional properties

    Time frame: 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.

Secondary outcomes

  1. FDI-2 evaluation criteria for biological properties

    Time frame: 2 years

    Clinical evaluations were conducted using the FDI-2 criteria by two experienced, calibrated, and blinded evaluators for biological properties (category B). Secondary caries, integrity of tooth structure at restoration margins, post-operative sensitivity, and pulp status) 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.

Other outcomes

  1. FDI-2 evaluation criteria for aesthetic properties

    Time frame: 2 years

    Clinical evaluations were conducted using the FDI-2 criteria by two experienced, calibrated, and blinded evaluators for aesthetic properties (category A). Surface gloss and texture, margin staining, color matching, anatomical form 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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

Clinical Performance of Bioactive Restorative Materials in Occlusal Restorations: Preliminary Results of a Split-mouth Study

Acronym: Bioactive

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 6, 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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