NCT06211582

Clinical Performances of 3-different Tooth-colored Restorative Materials in Class-II Cavities

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Hacettepe University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial comparatively investigate the clinical performances of 3 different tooth-colored restorative materials in the treatment of Class II cavities after 6 months and one year.

Detailed description

High plaque accumulation at the proximal surfaces of posterior teeth can lead to the development of caries and the necessity of dental treatments.The complexity of application methods for resin composites could influence the risk of secondary caries due to bacterial microleakage.In modern dentistry, simplified, esthetic, and satisfactory restoration of tooth decay has led to innovative material developments.Rapidly cured restorative materials applied in large increments with self-adhesive properties became an important solution for easy and effective applications. Restorative materials with bioactive or caries-protective abilities have been introduced, such as glass hybrid materials. Recently, to overcome the limitations of restorative materials, it was attempted to add caries-protective ions, especially alkaline and alkaline earth ions, such as calcium, in addition to phosphate or fluoride. This newly introduced material contains alkalizing properties due to the release of hydroxyl ions. In 2016, Ivoclar Vivadent developed a new restorative material consisting of a powder and a liquid part and commercially named this product "Cention N". Cention N has bioactive properties like glass ionomer cements. It has been developed to prevent demineralisation by neutralising acids through ion release. It contains alkaline fillers. Therefore, a new classification as "Alkasites" has emerged. One lesion in each patient will be randomly assigned to be restored using either the GC Gradia Direct Posterior, Cention N and Equia Forte HT. The adhesive, GC Solare Universal Bond will be used for adhesive procedures. The clinical procedure for the restorations will be performed by a single operator. The restorations will be evaluated by two calibrated examiners at baseline and at 6, 12, months in accordance with the FDI criteria. Data will be statistically analyzed using the Chi-square and Fischer's exact tests (p \< 0.05).

Conditions

• Caries,Dental

Interventions

Type	Name	Description
DEVICE	Cention N (Ivoclar Vivadent, Schaan, Liechtenstein)	The Alkasite-Based Tooth-Colored Material
DEVICE	Equia Forte HT ( GC, Tokyo, Japan)	Glass Hybrid Restorative Material
DEVICE	Gradia Direct Posterior ( GC, Tokyo, Japan)	Conventional Composite Resin

Timeline

• Start date: 2022-08-28
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2024-01-18
• Last updated: 2025-12-05

Locations

1 site across 1 country: Turkey (Türkiye)