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Patient Satisfaction and Crestal Bone Loss of Polymer Infiltrated Ceramic Network Versus Lithium Disilicate Implant Hybrid Abutment Crowns in Esthetic Zone

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ClinicalTrials.gov Identifier: NCT03333889
Recruitment Status : Unknown
Verified November 2017 by Inas Adel Mahmoud, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Inas Adel Mahmoud, Cairo University

Brief Summary:
P: Population: Patients requiring single unit implant restoration in esthetic zone I: Intervention: Polymer-infiltrated-ceramic-network abutment crown (VITA Enamic-VITA Zahnfabrik) C: Comparison: Lithium disilicate ceramic abutment crown (IPS e. max-Ivoclar Vivadent) O: Outcome: patient satisfaction , crestal bone loss and periodontal parameters T: Time: 12 months S :Randomized controlled trial research question:For patients receiving implants in esthetic zone, Does the use of polymer-infiltrated-ceramic-network hybrid abutment crown offer better patient satisfaction , less bone loss and better peri-implant clinical parameters when compared to lithium disilicate hybrid abutment crowns?

Condition or disease Intervention/treatment Phase
Hybrid Crowns on Single Implants in Esthetic Zone Other: Vita Enamic hybrid crown Other: emax hybrid crown Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: double blind :outcome asessor,participant
Primary Purpose: Treatment
Official Title: Patient Satisfaction and Crestal Bone Loss of Polymer Infiltrated Ceramic Network Versus Lithium Disilicate Implant Hybrid Abutment Crowns in Esthetic Zone
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Active Comparator: E-max hybrid crown
E-max hybrid crown Lithium Disilicate based ceramic which is characterized by high strength and optimum esthetics and considered a gold standard in anterior restorations
Other: emax hybrid crown
high srength glass ceramic that can be milled in sections up to 1mm .

Experimental: Vita Enamic hybrid crown
Vita Enamic hybrid crown polymer infilltrated ceramic network(hybrid ceramic) characterized by low modulus of elasticity that acts as cushion on implants.
Other: Vita Enamic hybrid crown
hybrid ceramic material in the form of mesoblocks where the ceramic block is attached to a ti base .The whole assembly is screw retained superstructure.




Primary Outcome Measures :
  1. patient satisfaction [ Time Frame: 12 months ]
    using visual analogue scale (o-unsatisfied up to max 10 satisfied)


Secondary Outcome Measures :
  1. crestal bone loss [ Time Frame: 12 months ]
    using digital subtraction technique



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients above 18 years old.
  2. Patients able to read and sign the informed consent document.
  3. Medically free patients or with controlled systemic disease.
  4. Patients with good bone quality and quantity evaluated using C.B.C.T.
  5. Patients willing to return for follow-up examinations and evaluation.
  6. Patients having single missing recently extracted premolar tooth.

Exclusion Criteria:

  1. Young patients in growth stage.
  2. Patients with unsuitable implantation sites (patients with major boney defects or sever bone resorption)
  3. Pregnant women to avoid any complication that may occur in dental office.
  4. Patients with uncontrolled systemic disease (hypertensive patient or uncontrolled diabetic patient)
  5. Psychiatric problems or unrealistic expectations.
  6. Multiple adjacent missing teeth.
  7. Patients with bad oral hygiene. -

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): NCT03333889


Contacts
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Contact: Inas Mahmoud, assistant lecturer +201008402645 inas.adel@dentistry.cu.edu.eg
Contact: Reham El Basty, lecturer 01207169671 Reham.elbasty@dentistry.cu.edu.eg

Locations
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Egypt
Inas adel mahmoud
Cairo, Egypt
Contact: inas Mahmoud, assistant leturer    01008402645    inas.adel@dentistry.cu.edu.eg   
Contact: Reham El Basty, lecturer    01207169671    Reham.elbasty@dentistry.cu.edu.eg   
Sponsors and Collaborators
Cairo University
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Responsible Party: Inas Adel Mahmoud, assistant lecturer,fixed prosthodontic department, faculty of oral and dental medicine, Cairo University
ClinicalTrials.gov Identifier: NCT03333889    
Other Study ID Numbers: CEBD-CU-2017-11-02
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
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