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Gingival Response and Marginal Adaptation of Zirconia Crowns With Two Subgingival Margin Designs

Primary Purpose

Gingival Recession, Localized

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Feather edge finish line preparation
Deep chamfer finish line preparation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession, Localized

Eligibility Criteria

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

Inclusion Criteria:

  • Patients 18 years to 50 years old
  • Dentate patients planned for a single full coverage restoration in the posterior area.
  • Patients with no active periodontal disease.
  • >2mm of keratinized tissue

Exclusion Criteria:

  • Smoking (>10 cigarettes a day)
  • Substance abuse history
  • Patients with poor oral hygiene and high caries index
  • Patients suffering from abnormal occlusal habits for example clenching or bruxism
  • Local or systemic disease (endocrine, renal, hematologic, hepatic, immunosuppressive)
  • Current steroid/chemotherapy
  • Head and neck irradiation
  • Pregnancy
  • Inability or unwillingness to return for follow up visits.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Active Comparator

    Arm Label

    Tested finish line preparation

    Comparator finish line preparation

    Arm Description

    Feather edge finish line preparation (Intervention)

    Deep chamfer finish line preparation (Comparator)

    Outcomes

    Primary Outcome Measures

    Position of the margin of the restoration in relation to the gingival margin position
    Scoring proposed by Paniz et al classified into either subgingival (not visible), equigingival (slightly visible) and supragingival (visible)

    Secondary Outcome Measures

    Bleeding on probing
    Scoring following Ainamo and Bay gingival bleeding index

    Full Information

    First Posted
    January 24, 2021
    Last Updated
    July 27, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04729569
    Brief Title
    Gingival Response and Marginal Adaptation of Zirconia Crowns With Two Subgingival Margin Designs
    Official Title
    Gingival Response and Marginal Adaptation of Zirconia Crowns With Two Subgingival Margin Designs: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2021 (Anticipated)
    Primary Completion Date
    November 1, 2022 (Anticipated)
    Study Completion Date
    December 1, 2022 (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
    Yes

    5. Study Description

    Brief Summary
    The aim of the study is to evaluate the effect of feather edge finish line and deep chamfer finish line on gingival position, bleeding on probing and marginal adaptation.
    Detailed Description
    The aim of the study is to evaluate the effect of feather edge finish line and deep chamfer finish line on gingival position, bleeding on probing and marginal adaptation. Gingival bleeding on probing will be evaluated before treatment. Preparation for all ceramic full coverage restoration will be performed according to manufacturer instructions by one operator. Type of finish line (whether feather edge or deep chamfer finish line) will be selected randomly according to a computer generated randomization list. Restorative margins will be placed subgingivally. Zirconia crowns will be fabricated for the prepared teeth and cemented using resin luting agent. At 6 months and 12 months after the cementation, restorative margin position relative to the gingival margin will be recorded. Bleeding on probing and marginal adaptation will also be recorded.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession, Localized

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Tested finish line preparation
    Arm Type
    Other
    Arm Description
    Feather edge finish line preparation (Intervention)
    Arm Title
    Comparator finish line preparation
    Arm Type
    Active Comparator
    Arm Description
    Deep chamfer finish line preparation (Comparator)
    Intervention Type
    Procedure
    Intervention Name(s)
    Feather edge finish line preparation
    Intervention Description
    Tooth preparation with feather edge finish line will be done to posterior teeth to receive all ceramic full coverage zirconia crowns.
    Intervention Type
    Procedure
    Intervention Name(s)
    Deep chamfer finish line preparation
    Intervention Description
    Tooth preparation with deep chamfer finish line will be done to posterior teeth to receive all ceramic full coverage zirconia crowns.
    Primary Outcome Measure Information:
    Title
    Position of the margin of the restoration in relation to the gingival margin position
    Description
    Scoring proposed by Paniz et al classified into either subgingival (not visible), equigingival (slightly visible) and supragingival (visible)
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Bleeding on probing
    Description
    Scoring following Ainamo and Bay gingival bleeding index
    Time Frame
    1 year
    Other Pre-specified Outcome Measures:
    Title
    Marginal adaptation
    Description
    Evaluation using Modified USPHS criteria
    Time Frame
    1 year

    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: Patients 18 years to 50 years old Dentate patients planned for a single full coverage restoration in the posterior area. Patients with no active periodontal disease. >2mm of keratinized tissue Exclusion Criteria: Smoking (>10 cigarettes a day) Substance abuse history Patients with poor oral hygiene and high caries index Patients suffering from abnormal occlusal habits for example clenching or bruxism Local or systemic disease (endocrine, renal, hematologic, hepatic, immunosuppressive) Current steroid/chemotherapy Head and neck irradiation Pregnancy Inability or unwillingness to return for follow up visits.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Gingival Response and Marginal Adaptation of Zirconia Crowns With Two Subgingival Margin Designs

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