Patient Satisfaction and Crestal Bone Loss of Polymer Infiltrated Ceramic Network Versus Lithium Disilicate Implant Hybrid Abutment Crowns in Esthetic Zone

P: Population: Patients requiring single unit implant restoration in esthetic zone I: Intervention: Polymer-infiltrated-ceramic-network abutment crown (VITA Enamic-VITA Zahnfabrik) C: Comparison: Lithium disilicate ceramic abutment crown (IPS e. max-Ivoclar Vivadent) O: Outcome: patient satisfaction , crestal bone loss and periodontal parameters T: Time: 12 months S :Randomized controlled trial research question:For patients receiving implants in esthetic zone, Does the use of polymer-infiltrated-ceramic-network hybrid abutment crown offer better patient satisfaction , less bone loss and better peri-implant clinical parameters when compared to lithium disilicate hybrid abutment crowns?

Study Overview

• Status: Unknown
• Conditions: Hybrid Crowns on Single Implants in Esthetic Zone
• Intervention / Treatment: Other: emax hybrid crown; Other: Vita Enamic hybrid crown

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Inas adel mahmoud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients above 18 years old.
2. Patients able to read and sign the informed consent document.
3. Medically free patients or with controlled systemic disease.
4. Patients with good bone quality and quantity evaluated using C.B.C.T.
5. Patients willing to return for follow-up examinations and evaluation.
6. Patients having single missing recently extracted premolar tooth.

Exclusion Criteria:

1. Young patients in growth stage.
2. Patients with unsuitable implantation sites (patients with major boney defects or sever bone resorption)
3. Pregnant women to avoid any complication that may occur in dental office.
4. Patients with uncontrolled systemic disease (hypertensive patient or uncontrolled diabetic patient)
5. Psychiatric problems or unrealistic expectations.
6. Multiple adjacent missing teeth.
7. Patients with bad oral hygiene. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: E-max hybrid crown; E-max hybrid crown Lithium Disilicate based ceramic which is characterized by high strength and optimum esthetics and considered a gold standard in anterior restorations	Other: emax hybrid crown; high srength glass ceramic that can be milled in sections up to 1mm .
Experimental: Vita Enamic hybrid crown; Vita Enamic hybrid crown polymer infilltrated ceramic network(hybrid ceramic) characterized by low modulus of elasticity that acts as cushion on implants.	Other: Vita Enamic hybrid crown; hybrid ceramic material in the form of mesoblocks where the ceramic block is attached to a ti base .The whole assembly is screw retained superstructure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	using visual analogue scale (o-unsatisfied up to max 10 satisfied)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
crestal bone loss	using digital subtraction technique	12 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: November 5, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 5, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CEBD-CU-2017-11-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No