search
Back to results

Clinical Assessment of Indirect Restoration Fabricated From Nano Hybrid Composite Blocks Versus Ceramic Blocks in Badly Broken Teeth One Year Follow up

Primary Purpose

Teeth Restoration

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
composite blocks
ceramic cad cam blocks
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Teeth Restoration

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with badly broken vital teeth
  • Young adult Males or female
  • Good oral hygiene measures
  • Cooperative patients approving to participate in the study

Exclusion Criteria:

  • Patients with a compromised medical history.
  • Severe or active periodontal disease
  • Severe medical complications
  • Lack of compliance
  • Endodontically treated teeth

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ceramic cad cam blocks

    composite cad cam blocks

    Arm Description

    Outcomes

    Primary Outcome Measures

    marginal integrity
    using usphs visual inspection

    Secondary Outcome Measures

    Full Information

    First Posted
    September 20, 2020
    Last Updated
    September 24, 2020
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04563624
    Brief Title
    Clinical Assessment of Indirect Restoration Fabricated From Nano Hybrid Composite Blocks Versus Ceramic Blocks in Badly Broken Teeth One Year Follow up
    Official Title
    Clinical Assessment Accourding to Modified Usphs"of Indirect Restoration Fabricated From Nano Hybrid Composite Blocks Versus Ceramic Blocks in Badly Broken Teeth One Year Follow up Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2020 (Anticipated)
    Primary Completion Date
    November 1, 2020 (Anticipated)
    Study Completion Date
    November 1, 2021 (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 compare one-year clinical performance of indirect restoration fabricated from nano hybrid composite CAD CAM blocks and ceramic blocks
    Detailed Description
    This research is conducted for comparing the clinical efficacy of nano hybrid composite blocks and ceramic blocks ., the choice of nano hybrid composite blocks based on the claim of the manufacturer, as it's considered to be promising , nano hybrid composite blocks has the highest fillers content (86% by weight), resembles natural teeth perfectly , Excellent physical values for flexural strength and abrasion, No firing required (a real one step ), can be processed using any conventional milling unit, can be finished and polished optimally, Ideal for grinding even in cases with thin edges.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ceramic cad cam blocks
    Arm Type
    Experimental
    Arm Title
    composite cad cam blocks
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    composite blocks
    Intervention Description
    cad cam composite blocks
    Intervention Type
    Drug
    Intervention Name(s)
    ceramic cad cam blocks
    Intervention Description
    ceramic cad cam blocks
    Primary Outcome Measure Information:
    Title
    marginal integrity
    Description
    using usphs visual inspection
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with badly broken vital teeth Young adult Males or female Good oral hygiene measures Cooperative patients approving to participate in the study Exclusion Criteria: Patients with a compromised medical history. Severe or active periodontal disease Severe medical complications Lack of compliance Endodontically treated teeth
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    HANEEN ELMOSELHY, mastrers
    Phone
    01003778829
    Email
    haneen.elmoselhy@bue.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Clinical Assessment of Indirect Restoration Fabricated From Nano Hybrid Composite Blocks Versus Ceramic Blocks in Badly Broken Teeth One Year Follow up

    We'll reach out to this number within 24 hrs