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Clinical Efficacy of Preformed Pediatric Zirconia and Metal Crown

Primary Purpose

Carious Teeth

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prefabricated pediatric zirconia crown group
Prefabricated stainless steel crown group
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carious Teeth

Eligibility Criteria

6 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy children aged 6-9 years with caries on primary molars Children without systemic disease or developmental dental anomalies that may affect caries susceptibility. Children whose cooperation is 'positive' or 'absolutely positive' according to the Frankl behavioral scale (Frankl et al., 1962). Those with deep dentin caries that do not extend to the pulp in the teeth to be treated The molars will be treated with a crown indication. Presence of symmetry of the primary molar to be treated in the opposite arch. The molar to be treated is in occlusion with the antagonist. Presence of caries on at least two surfaces of the molars to be treated. Absence of spontaneous pain, abscess, mobility, interradicular lesion in the tooth to be treated Patients whose parents and themselves agree to participate in the treatment Exclusion Criteria: Children whose treatment cannot be continued on the dental chair due to cooperation Molars that will soon be exfoliated, 1/2 of the root has been resorbed The presence of bruxism The presence of erosion or attrition-related wear on the opposing molar The patient does not come to the control appointment or does not want to continue to the research Have allergy to local anesthetic, nickel or chromium Complications during treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Prefabricated pediatric zirconia crown group

    Prefabricated stainless steel crown group

    Arm Description

    Zirconia crowns (ZK; EZ Crowns, Spring Oral Health Technologies, Inc:, Loomis, Calif., USA).

    Stainless Steel Crown (SSC, Kids Crown, Shinghung, Seoul, Korea)

    Outcomes

    Primary Outcome Measures

    Comparison of clinical success
    According to the criteria reported by Santamaria et al. (2004), clinical success will be categorized as successful, major failure, and minor failure. Successful: No clinical signs or symptoms of pulp pathology Tooth has exfoliated (without any minor/major failures) No deformations in the crown/restoration No pathology observed in radiographs Minor failure: Reversible pulpitis (No need for root canal treatment or extraction) Crown/restoration loss that can be restored Presence of deformations/fractures/perforations in the crown/restoration Permanent crown remaining submerged Presence of new caries at the margins Major failure: Irreversible pulpitis Crown/restoration loss that cannot be restored Inter-radicular radiolucency Internal root resorption

    Secondary Outcome Measures

    Parental satisfaction
    To assess parental satisfaction regarding the applied restorations, scoring of crowns' appearance, color, shape, size, and general appearance will be requested using a Likert-type scale (Suguna & Gurunathan, 2021). Score 5 indicates the highest level of satisfaction, while score 1 represents the lowest level of satisfaction. Not at all satisfied Not satisfied Neither satisfied nor dissatisfied (Neutral) Satisfied Very satisfied

    Full Information

    First Posted
    May 26, 2023
    Last Updated
    June 16, 2023
    Sponsor
    Marmara University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05910905
    Brief Title
    Clinical Efficacy of Preformed Pediatric Zirconia and Metal Crown
    Official Title
    Evaluation of Clinical Efficacy of Preformed Pediatric Zirconia Crown and Preformed Pediatric Metal Crown: A Randomized Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2024 (Anticipated)
    Study Completion Date
    March 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Marmara 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 study was planned to evaluate and compare the clinical success of prefabricated stainless steel crowns and zirconia crowns used in the primary molars. The study will be carried out in healthy children aged 6-9 years with caries on more than one surface of the primary molars.
    Detailed Description
    In this study, zirconia crowns will be compared with prefabricated stainless steel crowns in a randomized controlled manner. The study will be conducted in split-mouth to eliminate the effect of potential confounders. The obtained data will be analyzed using appropriate statistical methods.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carious Teeth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Prefabricated pediatric zirconia crown group
    Arm Type
    Experimental
    Arm Description
    Zirconia crowns (ZK; EZ Crowns, Spring Oral Health Technologies, Inc:, Loomis, Calif., USA).
    Arm Title
    Prefabricated stainless steel crown group
    Arm Type
    Active Comparator
    Arm Description
    Stainless Steel Crown (SSC, Kids Crown, Shinghung, Seoul, Korea)
    Intervention Type
    Procedure
    Intervention Name(s)
    Prefabricated pediatric zirconia crown group
    Intervention Description
    Zirconia crown application: After preparing the molars, the crown was cemented by passive seating with modified glass ionomer cement (GC FujiCEM Evolve, GC America, Alsip, USA).
    Intervention Type
    Procedure
    Intervention Name(s)
    Prefabricated stainless steel crown group
    Intervention Description
    Stainless steel crown application: After preparing the molars, the crown was filled with type-1 glass ionomer cement (Aqua Meron, Voco, Cuxhaven, Germany) and cemented.
    Primary Outcome Measure Information:
    Title
    Comparison of clinical success
    Description
    According to the criteria reported by Santamaria et al. (2004), clinical success will be categorized as successful, major failure, and minor failure. Successful: No clinical signs or symptoms of pulp pathology Tooth has exfoliated (without any minor/major failures) No deformations in the crown/restoration No pathology observed in radiographs Minor failure: Reversible pulpitis (No need for root canal treatment or extraction) Crown/restoration loss that can be restored Presence of deformations/fractures/perforations in the crown/restoration Permanent crown remaining submerged Presence of new caries at the margins Major failure: Irreversible pulpitis Crown/restoration loss that cannot be restored Inter-radicular radiolucency Internal root resorption
    Time Frame
    24 month
    Secondary Outcome Measure Information:
    Title
    Parental satisfaction
    Description
    To assess parental satisfaction regarding the applied restorations, scoring of crowns' appearance, color, shape, size, and general appearance will be requested using a Likert-type scale (Suguna & Gurunathan, 2021). Score 5 indicates the highest level of satisfaction, while score 1 represents the lowest level of satisfaction. Not at all satisfied Not satisfied Neither satisfied nor dissatisfied (Neutral) Satisfied Very satisfied
    Time Frame
    24 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy children aged 6-9 years with caries on primary molars Children without systemic disease or developmental dental anomalies that may affect caries susceptibility. Children whose cooperation is 'positive' or 'absolutely positive' according to the Frankl behavioral scale (Frankl et al., 1962). Those with deep dentin caries that do not extend to the pulp in the teeth to be treated The molars will be treated with a crown indication. Presence of symmetry of the primary molar to be treated in the opposite arch. The molar to be treated is in occlusion with the antagonist. Presence of caries on at least two surfaces of the molars to be treated. Absence of spontaneous pain, abscess, mobility, interradicular lesion in the tooth to be treated Patients whose parents and themselves agree to participate in the treatment Exclusion Criteria: Children whose treatment cannot be continued on the dental chair due to cooperation Molars that will soon be exfoliated, 1/2 of the root has been resorbed The presence of bruxism The presence of erosion or attrition-related wear on the opposing molar The patient does not come to the control appointment or does not want to continue to the research Have allergy to local anesthetic, nickel or chromium Complications during treatment.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Betül Şen Yavuz, DDS
    Phone
    +905399887646
    Email
    dtbetulsen@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ecem Akbeyaz Şivet, DDS

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Clinical Efficacy of Preformed Pediatric Zirconia and Metal Crown

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