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).

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Caries
• Intervention / Treatment: Other: Zirconomer improved

Detailed 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)

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: weaam mohamed ammar, master; Phone Number: 00201009432333; Email: weaam.abdelfatah@dentistry.cu.edu.eg
• Study Contact Backup: Name: Rawda Hesham Abd ElAziz, PhD; Phone Number: +21001097200; Email: rawda.hesham@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age group 18-55
• Presence of occluding tooth.
• Good oral hygiene

Exclusion Criteria:

• Poor periodontal status
• Adverse medical history.
• Potential behavioral problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Zirconomer improved; a nano zirconia reinforced glass ionomer, which has improved the mechanical, esthetic and handling properties than its previous successor.	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.
Active Comparator: Nano hybird resin composite; Resin composite (RC) is the gold standard esthetic restoration in proximal cavities due to their high aesthetic properties, increased mechanical durability and enhanced adhesion to tooth structure.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical performance	Postoperative Hypersensitivity Secondary caries	Change from the baseline at 6 months and at 12 months.
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.
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.
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wear resistance evaluation	"Wear measurements Measured by using WSxM software.	Change from the baseline at 6 months and at 12 months.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Ahmed El-Hoshy, Professor, Cairo university

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: May 29, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 29, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: Zirconomer Improved

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No