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

NCT ID: NCT02941575

Last Updated: 2016-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-05-31

Brief Summary

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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

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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.

Conditions

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Prosthesis Survival

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Control

Implant superstructure crown: All ceramic, IPS Emax

Group Type ACTIVE_COMPARATOR

All ceramic

Intervention Type OTHER

IPS Emax: is an all ceramic crown that has proven superior aesthetics and strength properties.

Intervention

Implant superstructure crown: Hybrid ceramic, crystal Ultra crown

Group Type EXPERIMENTAL

Crystal Ultra

Intervention Type OTHER

Crystal Ultra: is a resin nano-ceramic material, that combines both advantages of ceramics and composites.

Interventions

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Crystal Ultra

Crystal Ultra: is a resin nano-ceramic material, that combines both advantages of ceramics and composites.

Intervention Type OTHER

All ceramic

IPS Emax: is an all ceramic crown that has proven superior aesthetics and strength properties.

Intervention Type OTHER

Other Intervention Names

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hybrid ceramics, resin nanoceramic e.g Cerasmart IPS-Emax, all ceramic crowns

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Sherif Samir Bushra

Lecturer Assistance

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jylian El Guindy, Professor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

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Sherif Bushra

Role: CONTACT

01224029053

Other Identifiers

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CEBD-CU-2016-09-215

Identifier Type: -

Identifier Source: org_study_id

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