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).

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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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).

Conditions
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Dental Caries

Intervention / Treatment
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* Other: Zirconomer improved


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age group 18-55 Presence of occluding tooth. Good oral hygiene Exclusion Criteria: Poor periodontal status Adverse medical history. Potential behavioral problems

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Zirconomer improved<br>a nano zirconia reinforced glass ionomer, which has improved the mechanical, esthetic and handling properties than its previous successor. | Other: Zirconomer improved<br>* Zirconomer improved, is a nano zirconia reinforced glass ionomer, which has improved the mechanical, esthetic and handling properties than its previous successor.<br>|
| Active Comparator: Nano hybird resin composite<br>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<br>* Zirconomer improved, is a nano zirconia reinforced glass ionomer, which has improved the mechanical, esthetic and handling properties than its previous successor.<br>|

What is the study measuring?
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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. |