Clinical Performance of Bioactive Restorative Materials

NCT07394751 | Active Not Recruiting

• 2 other identifiers: E-68869993-000-1477638224S847
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries; Dental Adhesive Materials

Keywords

Bioactive Restorative Materials; Dental Restorations; Clinical trial; FDI-2 criteria

Outcome Measures

Primary Outcomes (1)

• FDI-2 evaluation criteria for functional properties

  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.

  2 years

Secondary Outcomes (1)

• FDI-2 evaluation criteria for biological properties

  2 years

Other Outcomes (1)

• FDI-2 evaluation criteria for aesthetic properties

  2 years

Study Arms (4)

Tetric N-Ceram BulkFill

ACTIVE COMPARATOR

Tetric N-Ceram Bulkfill application (control group; device 1) was randomly applied to patients.

Procedure: Tetric N Ceram Bulkfill application

Cention Forte

ACTIVE COMPARATOR

Cention Forte was randomly applied to patients.

Procedure: Cention Forte application

Stela Automix

ACTIVE COMPARATOR

Stela automix was randomly applied to patients.

Procedure: Stela Automix

Activa BioActive Restorative

ACTIVE COMPARATOR

Activa BioActive Restorative was randomly applied to patients.

Procedure: Activa BioActive Restorative

Interventions

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.

Tetric N-Ceram BulkFill

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.

Cention Forte

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.

Stela Automix

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.

Activa BioActive Restorative

Eligibility Criteria

• Age: 20 Years - 34 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University School of Dentistry

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Interventions

ACTIVA BioACTIVE-RESTORATIVE

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Cankut Canevi, DDS

  Ege University School of Dentistry Department of Restorative Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Randomized split mouth study design

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: November 1, 2024
• Primary Completion: April 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)