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Clinical Evaluation of Lithium Disilicate (e.Max) and Hybrid Nano-ceramic (Grandio) CAD/CAM Endocrowns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04757428
Recruitment Status : Completed
First Posted : February 17, 2021
Last Update Posted : October 25, 2022
Sponsor:
Information provided by (Responsible Party):
Sameh Abou-steit, Cairo University

Study Description
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Brief Summary:
The purpose of this study is to compare marginal adaptation, fracture, retention, shade matching and patient satisfaction between lithium disilicate (e.max) and hybrid nano-ceramic (Grandio) CAD/CAM endocrowns.

Condition or disease Intervention/treatment Phase
Personal Satisfaction Procedure: Endocrown Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Lithium Disilicate (e.Max) and Hybrid Nano-ceramic (Grandio) CAD/CAM Endocrowns (Randomized Clinical Trial)
Actual Study Start Date : January 11, 2019
Actual Primary Completion Date : March 11, 2022
Actual Study Completion Date : March 11, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Lithium disilicate
The intervention will be: Prosthetic endocrown
 Procedure: Endocrown
Endocrown
Active Comparator: Hybrid nanoceramic
The intervention will be: Prosthetic endocrown
 Procedure: Endocrown
Endocrown


Outcome Measures
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Primary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 2 years ]
    Using Binary Visual Analogue scale (Satisfied/ not satisfied)


Secondary Outcome Measures :
  1. Shade matching [ Time Frame: 2 years ]
    Using the modified United States Public Health Service criteria (Modified USPHS)- categorical


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with good oral hygiene
  • Patients having one or more endodontically treated molars that need prosthetic restoration.
  • Molars should have enough tooth structure for endocrown restoration with minimum 3 walls with thickness not less than 1.5 mm and gingival step placed supragingival
  • Fully erupted molars
  • Molars free of developmental defect
  • Healthy periodontium
  • Absence of periapical pathosis
  • Acceptable endodontic treatment and proper bone support

Exclusion Criteria:

  • Patients with bad oral hygiene
  • Patients with active periodontal disease
  • Patients with missing teeth opposing to the area intended for restoration
  • Patients with parafunctional habits or psychiatric problems or unrealistic expectation.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04757428


Locations
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Egypt
Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Sameh Sh Abou-steit, PhD Lecturer of Fixed Prosthodontics
More Information
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Publications:

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Responsible Party: Sameh Abou-steit, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT04757428    
Other Study ID Numbers: CEBD-2019-3-080
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: October 25, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sameh Abou-steit, Cairo University:
Lithium disilicate
hybrid ceramic