NCT05965297

Comparison of Two GIC's in the Restoration of Posterior Class II Lesions in the Primary Dentition

Comparison of Two Conventional Glass Ionomer Cements in the Restoration of Posterior Class II Lesion in the Primary Dentition: a Randomized Controlled Non Inferiority Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: DMG Dental Material Gesellschaft mbH · Industry
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the clinical performance of a novel restorative glass ionomer (DeltaFil, DMG) in comparison to an established restorative glass ionomer (Riva Self Cure HV, SDI) in the restoration of Class II cavities in primary molars.

Detailed description

Dental caries (tooth decay) remains one of the most prevalent diseases worldwide. It is a dynamic and continuous process that, if uncontrolled, eventually leads to cavitation and the need for restorative treatment to maintain the form and function of the tooth.Today there are many possibilities for direct restorations, e.g. resin composites, compomers, resin-modified glass ionomer cements (RMGICs) and glass ionomer cements (GICs), which all offer their own advantages and disadvantages. GIC are particularly suitable for treatments in young patients due to their high biocompatibility, fluoride release, less moisture and technique sensitivity as well as compatibility with Atraumatic restorative treatment (ART) treatment. However, these materials have lower mechanical properties compared to other restorative materials, which negatively affects the survival rate when placed in load bearing areas. Fracture, loss and wear being the most common causes for failure. This randomized, controlled non-inferiority trial aims to evaluate the performance of the new restorative glass ionomer DeltaFil, that offers an increased fracture toughness, in comparison to an established restorative glass-ionomer (Riva Self Cure HV).

Conditions

• Dental Caries

Interventions

Type	Name	Description
DEVICE	DeltaFil	Cavities are prepared using rotary instruments/diamond burs. Afterwards, the cavity is conditioned (using DeltaFil conditioner) and cleaned, with subsequent insertion of a conventional restorative glass-ionomer (DeltaFil). During the curing phase and after finishing Riva Coat will be applied to all restoration surfaces for moisture protection.
DEVICE	Riva Self Cure HV	Cavities are prepared using rotary instruments/diamond burs. Afterwards, the cavity is conditioned (using Riva conditioner) and cleaned, with subsequent insertion of a conventional restorative glass-ionomer (Riva Self Cure HV). During the curing phase and after finishing Riva Coat will be applied to all restoration surfaces for moisture protection.

Timeline

• Start date: 2023-08-01
• Primary completion: 2027-08-01
• Completion: 2030-08-01
• First posted: 2023-07-28
• Last updated: 2023-07-28

Locations

2 sites across 2 countries: Brazil, Portugal