Back to resultsPatient Satisfaction and Peri-Implant Tissue Success of Hybrid Ceramic Versus E-Max Superstructures
Primary Purpose
Prosthesis Survival
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Crystal Ultra
All ceramic
Sponsored by
About this trial
This is an interventional treatment trial for Prosthesis Survival
Eligibility Criteria
Inclusion Criteria:
- Age above 18 years with at least one tooth missing in the esthetic area.
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.
- Patient with good oral hygiene.
- Class 1 occlusion.
- Lack of excessive parafunctional activity leading to implant failure.
- Tooth extracted not less than 6 month.
Exclusion Criteria:
- Young patients in whom the jaws are still growing. (Less than 18 years).
- Jaw pathology.
- Smokers.
- Uncontrolled Diabetic or particularly insulin-dependent.
- Radiotherapy to the neck or face.
- Multiple loss of teeth which may be indicated for more complicated procedure.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Intervention
Arm Description
Implant superstructure crown: All ceramic, IPS Emax
Implant superstructure crown: Hybrid ceramic, crystal Ultra crown
Outcomes
Primary Outcome Measures
Esthetic Patient satisfaction
Measurement unit is Binary
Secondary Outcome Measures
Peri-implant tissue success (A-Marginal Bone Loss, B-Relative attachment level, C-Peri-Implant Probing depth, D-Sulcus bleeding)
Measurement unit is Categorical
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02941575
Brief Title
Patient Satisfaction and Peri-Implant Tissue Success of Hybrid Ceramic Versus E-Max Superstructures
Official Title
Esthetic Patient Satisfaction and Peri-Implant Tissue Success of Crystal Ultra Hybrid Ceramic Compared to E-Max Superstructures in Esthetic Zone
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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)?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis Survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Implant superstructure crown: All ceramic, IPS Emax
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Implant superstructure crown: Hybrid ceramic, crystal Ultra crown
Intervention Type
Other
Intervention Name(s)
Crystal Ultra
Other Intervention Name(s)
hybrid ceramics, resin nanoceramic e.g Cerasmart
Intervention Description
Crystal Ultra: is a resin nano-ceramic material, that combines both advantages of ceramics and composites.
Intervention Type
Other
Intervention Name(s)
All ceramic
Other Intervention Name(s)
IPS-Emax, all ceramic crowns
Intervention Description
IPS Emax: is an all ceramic crown that has proven superior aesthetics and strength properties.
Primary Outcome Measure Information:
Title
Esthetic Patient satisfaction
Description
Measurement unit is Binary
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Peri-implant tissue success (A-Marginal Bone Loss, B-Relative attachment level, C-Peri-Implant Probing depth, D-Sulcus bleeding)
Description
Measurement unit is Categorical
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age above 18 years with at least one tooth missing in the esthetic area.
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.
Patient with good oral hygiene.
Class 1 occlusion.
Lack of excessive parafunctional activity leading to implant failure.
Tooth extracted not less than 6 month.
Exclusion Criteria:
Young patients in whom the jaws are still growing. (Less than 18 years).
Jaw pathology.
Smokers.
Uncontrolled Diabetic or particularly insulin-dependent.
Radiotherapy to the neck or face.
Multiple loss of teeth which may be indicated for more complicated procedure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherif Bushra
Phone
01224029053
Email
sherifsamir3000@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jylian El Guindy, Professor
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Patient Satisfaction and Peri-Implant Tissue Success of Hybrid Ceramic Versus E-Max Superstructures
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