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

Not Applicable

• Conditions: Prosthesis Survival

• Registration Number: NCT02941575
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-19
• Last Update Submitted: 2016-10-19
• Study First Posted: 2016-10-21
• Last Update Posted: 2016-10-21
• Study Start: 2016-12
• Primary Completion: 2018-03
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Esthetic Patient satisfaction	1 year	Measurement unit is Binary

Secondary Outcome Measures

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