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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).

Primary Purpose

Dental Caries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Zirconomer improved
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Active Comparator

    Arm Label

    Zirconomer improved

    Nano hybird resin composite

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

    Clinical performance
    Postoperative Hypersensitivity Secondary caries
    Clinical performance
    Secondary caries and measured by Modified United States Public Health Service Criteria (USPHS)
    Clinical performance
    Gross fracture and measured by Modified United States Public Health Service Criteria (USPHS)
    Clinical performance
    Color match and measured by Modified United States Public Health Service Criteria (USPHS)
    Clinical performance
    Cavo-surface marginal discoloration and measured by Modified United States Public Health Service Criteria (USPHS)
    Clinical performance
    Marginal integrity and measured by Modified United States Public Health Service Criteria (USPHS)
    Clinical performance
    Proximal contact and measured by Modified United States Public Health Service Criteria (USPHS)

    Secondary Outcome Measures

    Wear resistance evaluation
    "Wear measurements Measured by using WSxM software.

    Full Information

    First Posted
    February 2, 2022
    Last Updated
    May 29, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05403008
    Brief 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).
    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).
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2022 (Anticipated)
    Primary Completion Date
    June 2022 (Anticipated)
    Study Completion Date
    February 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.
    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Assessors and statistician
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Zirconomer improved
    Arm Type
    Other
    Arm Description
    a nano zirconia reinforced glass ionomer, which has improved the mechanical, esthetic and handling properties than its previous successor.
    Arm Title
    Nano hybird resin composite
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Zirconomer improved
    Intervention Description
    Zirconomer improved, is a nano zirconia reinforced glass ionomer, which has improved the mechanical, esthetic and handling properties than its previous successor.
    Primary Outcome Measure Information:
    Title
    Clinical performance
    Description
    Postoperative Hypersensitivity Secondary caries
    Time Frame
    Change from the baseline at 6 months and at 12 months.
    Title
    Clinical performance
    Description
    Secondary caries and measured by Modified United States Public Health Service Criteria (USPHS)
    Time Frame
    Change from the baseline at 6 months and at 12 months.
    Title
    Clinical performance
    Description
    Gross fracture and measured by Modified United States Public Health Service Criteria (USPHS)
    Time Frame
    Change from the baseline at 6 months and at 12 months.
    Title
    Clinical performance
    Description
    Color match and measured by Modified United States Public Health Service Criteria (USPHS)
    Time Frame
    Change from the baseline at 6 months and at 12 months.
    Title
    Clinical performance
    Description
    Cavo-surface marginal discoloration and measured by Modified United States Public Health Service Criteria (USPHS)
    Time Frame
    Change from the baseline at 6 months and at 12 months.
    Title
    Clinical performance
    Description
    Marginal integrity and measured by Modified United States Public Health Service Criteria (USPHS)
    Time Frame
    Change from the baseline at 6 months and at 12 months.
    Title
    Clinical performance
    Description
    Proximal contact and measured by Modified United States Public Health Service Criteria (USPHS)
    Time Frame
    Change from the baseline at 6 months and at 12 months.
    Secondary Outcome Measure Information:
    Title
    Wear resistance evaluation
    Description
    "Wear measurements Measured by using WSxM software.
    Time Frame
    Change from the baseline at 6 months and at 12 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age group 18-55 Presence of occluding tooth. Good oral hygiene Exclusion Criteria: Poor periodontal status Adverse medical history. Potential behavioral problems
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    weaam mohamed ammar, master
    Phone
    00201009432333
    Email
    weaam.abdelfatah@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rawda Hesham Abd ElAziz, PhD
    Phone
    +21001097200
    Email
    rawda.hesham@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed El-Hoshy, Professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    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).

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