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

Sponsor
Cairo University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04757428
Collaborator
(none)
14
Enrollment
1
Location
2
Arms
26
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Endocrown
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
14 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 Control Clinical Trial)
Actual Study Start Date :
Jan 11, 2019
Anticipated Primary Completion Date :
Mar 11, 2021
Anticipated Study Completion Date :
Mar 11, 2021

Arms and Interventions

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

Primary Outcome Measures

  1. Patient satisfaction [2 years]

    Using Binary Visual Analogue scale (Satisfied/ not satisfied)

Secondary Outcome Measures

  1. Shade matching [2 years]

    Using the modified United States Public Health Service criteria (Modified USPHS)- categorical

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Cairo University Cairo Egypt

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Sameh Sh Abou-steit, PhD, Lecturer of Fixed Prosthodontics

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sameh Abou-steit, Principal investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT04757428
Other Study ID Numbers:
  • CEBD-2019-1-110
First Posted:
Feb 17, 2021
Last Update Posted:
Feb 17, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sameh Abou-steit, Principal investigator, Cairo University
Lithium disilicate
hybrid ceramic

Study Results

No Results Posted as of Feb 17, 2021