- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02941575
Patient Satisfaction and Peri-Implant Tissue Success of Hybrid Ceramic Versus E-Max Superstructures
Esthetic Patient Satisfaction and Peri-Implant Tissue Success of Crystal Ultra Hybrid Ceramic Compared to E-Max Superstructures in Esthetic Zone
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sherif Bushra
- Phone Number: 01224029053
- Email: sherifsamir3000@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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:
|
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:
|
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
Sponsor
Investigators
- Principal Investigator: Jylian El Guindy, Professor, Cairo University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Prosthesis Failure
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Methamphetamine
Other Study ID Numbers
- CEBD-CU-2016-09-215
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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