Clinical Performances of 3-different Tooth-colored Restorative Materials

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06211582
Study type	Interventional
Source	Hacettepe University
Contact
Status	Active, not recruiting
Phase	N/A
Start date	September 15, 2022
Completion date	March 20, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms