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

NCT06833528 | Active Not Recruiting

• 1 other identifier: KA-23072
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries; Dental Caries Class II

Keywords

bioactive restorative materials; dental caries; alkasite

Outcome Measures

Primary Outcomes (1)

• Retention Alpha for at least 90% of the restorations

  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.

  18 months

Study Arms (2)

Cention Forte

EXPERIMENTAL

Self-etch primer will be applied. Cention Forte capsule will be activated, mixed, and directly applied. Light curing will be performed to accelerate polymerization.

Device: tooth restoration

Composite Resin

ACTIVE COMPARATOR

Selective enamel etching with 37% phosphoric acid for 15 seconds. G-Premio Universal Adhesive application. Incremental layering with light curing after each 2 mm layer.

Device: tooth restoration

Interventions

tooth restoration DEVICE

restoration of class II cavities

Cention Forte

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals aged 18-35 years
• Brushing twice daily and maintaining good oral hygiene
• At least two interproximal Class II carious lesions in molar teeth
• At least 20 teeth in occlusion with antagonist contacts
• Signed informed consent and completion of initial periodontal therapy

You may not qualify if:

• Pregnancy or lactation
• Advanced periodontal disease
• Bruxism or malocclusion
• Allergy to resin-based materials or local anesthesia
• Endodontically treated teeth or those requiring pulp capping

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altindag, 06530, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

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

Model Details: randomized controlled clinical trial

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start: July 13, 2023
• Primary Completion: March 1, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

TU (1)