Patient Satisfaction and Peri-Implant Tissue Success of Hybrid Ceramic Versus E-Max Superstructures

October 19, 2016 updated by: Sherif Samir Bushra, Cairo University

Esthetic Patient Satisfaction and Peri-Implant Tissue Success of Crystal Ultra Hybrid Ceramic Compared to E-Max Superstructures in Esthetic Zone

In patients receiving implants in the esthetic zone, would the use of new Nano hybrid ceramic crown material (Crystal Ultra) improve esthetic patient satisfaction and peri-implant tissue success when compared with Lithium Disilicate crown (E-max)?

Study Overview

Status

Unknown

Conditions

Detailed Description

The patient will be treated in visits designated as follows:

Visit 1: Preoperative records, face-to-face adherence reminder session, signing consents, clinical, radiographic examination and primary impression for diagnostic cast construction.

Visit 2: (first stage surgery): implant placement surgical procedure and postoperative radiograph.

Visit 3: After 3months (second stage surgery): re-opening of surgical site, placement of healing abutments and temporary crowns.

Visit 4: After 2 weeks, removing of temporary restorations and taking of final impressions Visit 5: placement of different ceramic crown superstructures and recording different outcome values.

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age above 18 years with at least one tooth missing in the esthetic area.
  2. Available bone for implant placement:

    A. Labial and Palatal Plate of bone not less than 2mm. B. Mesio- distal dimension not less than 6.5mm. C. Bone length not less than 9mm.

  3. Patient with good oral hygiene.
  4. Class 1 occlusion.
  5. Lack of excessive parafunctional activity leading to implant failure.
  6. Tooth extracted not less than 6 month.

Exclusion Criteria:

  1. Young patients in whom the jaws are still growing. (Less than 18 years).
  2. Jaw pathology.
  3. Smokers.
  4. Uncontrolled Diabetic or particularly insulin-dependent.
  5. Radiotherapy to the neck or face.
  6. Multiple loss of teeth which may be indicated for more complicated procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Implant superstructure crown: All ceramic, IPS Emax
IPS Emax: is an all ceramic crown that has proven superior aesthetics and strength properties.
Other Names:
  • IPS-Emax, all ceramic crowns
Experimental: Intervention
Implant superstructure crown: Hybrid ceramic, crystal Ultra crown
Crystal Ultra: is a resin nano-ceramic material, that combines both advantages of ceramics and composites.
Other Names:
  • hybrid ceramics, resin nanoceramic e.g Cerasmart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Esthetic Patient satisfaction
Time Frame: 1 year
Measurement unit is Binary
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-implant tissue success (A-Marginal Bone Loss, B-Relative attachment level, C-Peri-Implant Probing depth, D-Sulcus bleeding)
Time Frame: 1 year
Measurement unit is Categorical
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jylian El Guindy, Professor, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Estimate)

October 21, 2016

Last Update Submitted That Met QC Criteria

October 19, 2016

Last Verified

October 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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