Clinical Performance and Wear Resistance of Highly Translucent Nano Zirconia Reinforced Glass Ionomer Filling Versus Conventional Resin Composite Restorations in Patients With Proximal Carious Teeth. (A One-year Randomized Clinical Trial).

Dental Caries Clinical Trial

Official title:

Clinical Performance and Wear Resistance of Highly Translucent Nano Zirconia Reinforced Glass Ionomer Filling Versus Conventional Resin Composite Restorations in Patients With Proximal Carious Teeth. (A One-year Randomized Clinical Trial).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05403008
• Other study ID #: Zirconomer Improved
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: February 2023

Study information

• Verified date: May 2022
• Source: Cairo University
• Contact: weaam mohamed ammar, master
• Phone: 00201009432333
• Email: weaam.abdelfatah[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized clinical study aims to evaluate the clinical performance and occlusal wear resistance of nano-zirconia reinforced glass ionomer restorations in comparison to Nano-hybrid resin composite in proximal cavities.

Description:

Statement of the problem:

The glass ionomer restorations have a wide use in dental community. Proximal restoration is a challenge, due to the high forces present in this area that require more high fracture resistance restoration material which is not obtained in the most of the versions of glass ionomer restorations that are available in dental market.(Safy, 2019)

Rationale for choice of intervention:

Zirconomer improved, is a nano zirconia reinforced glass ionomer, which has improved the mechanical, esthetic and handling properties than its previous successor, zirconomer. Zirconomer is commercialized as a white amalgam as it features mechanical properties similar to amalgam restorations. In this generation also, translucency is improved to be similar to the tooth structure.(Shetty et al, 2017) As Zirconomer improved is reinforced material, it is expected that has high wear resistance than the conventional glass ionomer restorations. (Hesse et al., 2018)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: February 2023
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age group 18-55

• Presence of occluding tooth.

• Good oral hygiene

Exclusion Criteria:

• Poor periodontal status

• Adverse medical history.

• Potential behavioral problems

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• Zirconomer improved
Zirconomer improved, is a nano zirconia reinforced glass ionomer, which has improved the mechanical, esthetic and handling properties than its previous successor.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performance	Postoperative Hypersensitivity Secondary caries	Change from the baseline at 6 months and at 12 months.
Primary	Clinical performance	Secondary caries and measured by Modified United States Public Health Service Criteria (USPHS)	Change from the baseline at 6 months and at 12 months.
Primary	Clinical performance	Gross fracture and measured by Modified United States Public Health Service Criteria (USPHS)	Change from the baseline at 6 months and at 12 months.
Primary	Clinical performance	Color match and measured by Modified United States Public Health Service Criteria (USPHS)	Change from the baseline at 6 months and at 12 months.
Primary	Clinical performance	Cavo-surface marginal discoloration and measured by Modified United States Public Health Service Criteria (USPHS)	Change from the baseline at 6 months and at 12 months.
Primary	Clinical performance	Marginal integrity and measured by Modified United States Public Health Service Criteria (USPHS)	Change from the baseline at 6 months and at 12 months.
Primary	Clinical performance	Proximal contact and measured by Modified United States Public Health Service Criteria (USPHS)	Change from the baseline at 6 months and at 12 months.
Secondary	Wear resistance evaluation	"Wear measurements Measured by using WSxM software.	Change from the baseline at 6 months and at 12 months.