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

Prosthesis Survival Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02941575
• Other study ID #: CEBD-CU-2016-09-215
• Status: Not yet recruiting
• Phase: N/A
• First received: October 18, 2016
• Last updated: October 19, 2016
• Start date: December 2016
• Est. completion date: May 2018

Study information

• Verified date: October 2016
• Source: Cairo University
• Contact: Sherif Bushra
• Phone: 01224029053
• Email: sherifsamir3000[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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)?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: May 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prosthesis Failure
• Prosthesis Survival

Intervention

Other:
• Crystal Ultra
Crystal Ultra: is a resin nano-ceramic material, that combines both advantages of ceramics and composites.
• All ceramic
IPS Emax: is an all ceramic crown that has proven superior aesthetics and strength properties.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Esthetic Patient satisfaction	Measurement unit is Binary	1 year	No
Secondary	Peri-implant tissue success (A-Marginal Bone Loss, B-Relative attachment level, C-Peri-Implant Probing depth, D-Sulcus bleeding)	Measurement unit is Categorical	1 year	No