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Shade Matching Potential of Universal Shade Resin Composite Materials Compared to Multi Shade Resin Composite in Restoration of Carious Cervical Lesions in Anterior Teeth

Primary Purpose

Class V Dental Caries

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

About this trial

This is an interventional treatment trial for Class V Dental Caries

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Class V carious lesions in anterior teeth
  • Vital upper or lower anterior teeth with no signs of irreversible pulpitis and necrosis.
  • Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth

Exclusion Criteria:

  • Deep carious defects ( Close to pulp, less than 1 mm distance)
  • Periapical pathology or signs of pulpal pathology
  • Endodontically treated teeth
  • Tooth hypersensitivity
  • Possible prosthodontic restoration of teeth
  • Heavy occlusion and occlusal contacts or history of bruxism
  • Severe periodontal affection
  • Lesions in premolars and molars
  • Posterior teeth

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Filtek Z350XT

    Essentia universal shade, GC composite

    Omnichroma composite

    Arm Description

    Outcomes

    Primary Outcome Measures

    Clinical performance (USPHS criteria)
    USPHS criteria
    Clinical performance (USPHS criteria)
    USPHS criteria
    Clinical performance (USPHS criteria)
    USPHS criteria

    Secondary Outcome Measures

    Full Information

    First Posted
    June 27, 2022
    Last Updated
    July 16, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05465850
    Brief Title
    Shade Matching Potential of Universal Shade Resin Composite Materials Compared to Multi Shade Resin Composite in Restoration of Carious Cervical Lesions in Anterior Teeth
    Official Title
    Shade Matching Potential of Universal Shade Resin Composite Materials Compared to Multi Shade Resin Composite in Restoration of Carious Cervical Lesions in Anterior Teeth ( Randomized Clinical Trial ) - 1 Year Follow up
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2022 (Anticipated)
    Primary Completion Date
    August 2023 (Anticipated)
    Study Completion Date
    August 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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the study is to clinically evaluate the shade matching and clinical performance of the Universal shade composites Omnichroma and GC Essentia versus the multi shade composite Filtek Z350XT in restoring cervical lesions of anterior teeth.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Filtek Z350XT
    Arm Type
    Active Comparator
    Arm Title
    Essentia universal shade, GC composite
    Arm Type
    Experimental
    Arm Title
    Omnichroma composite
    Arm Type
    Experimental
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Modified USPHS criteria
    Intervention Description
    It assess the restorations with visual inspection using a mirror and explorer. It includes Marginal integrity, shade matching, retention, marginal discoloration, gingival inflammation, and recurrent caries.
    Primary Outcome Measure Information:
    Title
    Clinical performance (USPHS criteria)
    Description
    USPHS criteria
    Time Frame
    baseline: 1 week
    Title
    Clinical performance (USPHS criteria)
    Description
    USPHS criteria
    Time Frame
    6 months
    Title
    Clinical performance (USPHS criteria)
    Description
    USPHS criteria
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Class V carious lesions in anterior teeth Vital upper or lower anterior teeth with no signs of irreversible pulpitis and necrosis. Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth Exclusion Criteria: Deep carious defects ( Close to pulp, less than 1 mm distance) Periapical pathology or signs of pulpal pathology Endodontically treated teeth Tooth hypersensitivity Possible prosthodontic restoration of teeth Heavy occlusion and occlusal contacts or history of bruxism Severe periodontal affection Lesions in premolars and molars Posterior teeth

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Shade Matching Potential of Universal Shade Resin Composite Materials Compared to Multi Shade Resin Composite in Restoration of Carious Cervical Lesions in Anterior Teeth

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