Clinical Performance of Novel Alkasite Restorative Material "Cention Forte" in Class II Restorations

Condition(s) studied

Investigational drug(s) / intervention(s)

tooth restoration: restoration of class II cavities

tooth restoration: restoration of class II cavities

Study summary

Background \& Rationale:

Self-adhesive materials eliminate the need for adhesive protocols, offering advantages for direct restorations. The bulk-fill technique simplifies application by allowing a single-layer restoration. Glass ionomer cements (GICs) provide benefits such as fluoride release, remineralization, and moisture tolerance but have limitations, including poor aesthetics and low mechanical strength. To overcome these, hybrid materials combining GIC properties with composite durability have emerged.

Cention Forte, a capsulated alkasite restorative material, offers high flexural strength (\>100 MPa), bioactivity, and ease of application. The manufacturer claims it is an ideal posterior restorative, potentially replacing composite resins and amalgam. Given that composite restorations fail more frequently in patients with isolation difficulties, limited mouth opening, or parafunctional habits, alternative materials are needed. This study evaluates Cention Forte as an alternative to conventional composites.

Objective:

To compare the clinical performance of Cention Forte with a universal composite resin (G-aenial Achord, GC) in Class II restorations over 18 months using FDI (World Dental Federation) criteria.

Hypothesis:

H₀: No significant difference between Cention Forte and composite resin after 18 months based on FDI criteria.

Primary Endpoint: At least 90% of restorations remain intact at 18 months with no significant differences in clinical performance.

Study Design:

A randomized, controlled, single-blind clinical trial with 30 healthy volunteers (18-35 years old), each receiving two restorations (one with Cention Forte, one with G-aenial Achord). Bite-wing radiographs will be taken before and after treatment, and at 6 , 12 and 18 months.

Eligibility Criteria:

Inclusion:

* 18-35 years old, systemically healthy.
* Brushing twice daily, at least 20 teeth in occlusion.
* At least two interproximal Class II lesions.
* Signed informed consent.

Exclusion:

* Pregnancy/lactation.
* Advanced periodontal disease, bruxism, malocclusion.
* Allergy to resin materials or local anesthesia.
* Endodontically treated teeth or pulp capping cases.

Restorative Procedure:

Study Group (Cention Forte):

Self-etch primer applied, followed by Cention Forte placement and light-curing.

Control Group (G-aenial Achord, GC):

Selective enamel etching with 37% phosphoric acid, followed by G-Premio Universal Adhesive and incremental layering with light-curing.

Clinical Evaluations (FDI Criteria):

Aesthetic properties: Color match, marginal discoloration, anatomical form. Functional properties: Fracture resistance, marginal adaptation, occlusal wear, proximal contact.

Biological properties: Postoperative sensitivity, secondary caries, periodontal response.

Scoring: 1 (excellent) to 5 (unacceptable).

Statistical Analysis:

Chi-square/Fisher's Exact Test: Compare clinical performance. Wilcoxon signed-rank test: Evaluate performance over time. Kaplan-Meier survival analysis: Assess restoration longevity. p \< 0.05 considered statistically significant.

Ethical Considerations \& Data Management:

Ethical approval from Hacettepe University Clinical Research Ethics Committee. Registration on ClinicalTrials.gov. Data secured and encrypted, accessible only to authorized personnel.

Expected Impact:

This study will assess whether Cention Forte is a viable alternative to composites, particularly for challenging clinical cases where isolation and durability are concerns.

Eligibility

Primary outcome measure(s)

• Retention Alpha for at least 90% of the restorations — 18 months
  The primary factor for determining the clinical performance of a restorative material is the retention rate. It represents the survival rates of the restorations after a period of time. According to ADA guidelines, a restorative material should show at leat 90% alpha retention rate after 18 months to be considered as clinically acceptable. The retention is assesed as alpha (retentive restoratation) or charlie (failed restoration). Clinical evaluation is performed to examine if the restoration is in place or has fallen.

Trial sites (1)

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