NCT05605457

Clinical Performance of Nanohybrid Resin Composite Lined With PRG Barrier Coat Compared to Resin Modified Glass Ionomer in Class V Carious Cavities Over 18 Months: Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Class V carious lesions will be restored using two different restorative materials either Resin modified glass ionomer or nanohybrid resin composite lined by PRG barrier coat. Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline, at 6 months, 12 months and at 18 months. The restorations will be clinically examined according to modified USPHS criteria in terms of retention, marginal adaptation, marginal discoloration, secondary caries and postoperative sensitivity.

Detailed description

Class V carious lesions will be restored using two different restorative materials either resin modified glass ionomer or nanohybrid resin composite lined by PRG barrier coat.Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline, at 3 months, 6 months, 12 months and at 18 months. The restorations will be clinically examined according to modified USPHS criteria in terms of retention, marginal adaptation, marginal discoloration, secondary caries and postoperative sensitivity.

Conditions

• Class V Dental Caries

Interventions

Type	Name	Description
DEVICE	PRG barrier coat + nanohybrid composite	It is a light cured surface-partially reacted glass (S-PRG) filler particles with a multifunctional glass core embedded in a resin matrix.
DEVICE	resin modified glass ionomer	RMGIC are glass-ionomer cements with small quantity of monomers and initiators so the acid-base reaction is supplemented by a second polymerization reaction

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-06-01
• Completion: 2024-08-01
• First posted: 2022-11-04
• Last updated: 2022-11-04

Regulatory

• FDA-regulated device study