Pink and White Esthetic Scores of Polymer-infiltrated-ceramic-network and Lithium Disilicate Implant Hybrid Abutment Crowns

Pink and White Esthetic Scores of Polymer-infiltrated-ceramic-network and Lithium Disilicate Implant Hybrid Abutment Crowns: Randomized Clinical Trial

The aim of this study is to evaluate the effect of polymer-infiltrated-ceramic-network hybrid ceramic on pink and white esthetics in comparison with lithium disilicate.

The research hypothesis is that there will be comparable clinical performance results between polymer-infiltrated-ceramic-network and lithium disilicate hybrid abutment crowns.

Study Overview

• Status: Unknown
• Conditions: Dental Implants
• Intervention / Treatment: Other: Lithium disilicate (IPS e.max) hybrid abutment crown; Other: PICN (VITA Enamic) hybrid abutment crown

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Literate, capable of reading and signing the informed consent document
• Healthy, free from or with controlled systemic disease
• With acceptable oral health to support implant restorations
• With good bone quality and quantity
• Cooperative, accepting follow up and maintenance sessions
• Having single missing tooth in esthetic zone

Exclusion Criteria:

• Under 18 years old
• Illiterate, unable of comprehending or signing the informed consent document
• Unhealthy with uncontrolled systemic disease
• Pregnancy
• With unfavorable oral state that might affect implant procedure and restoration
• Uncooperative, not willing to return for follow up visits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: IPS e.max hybrid abutment crown	Other: Lithium disilicate (IPS e.max) hybrid abutment crown; Glass ceramic
EXPERIMENTAL: VITA Enamic hybrid abutment crown	Other: PICN (VITA Enamic) hybrid abutment crown; Hybrid ceramic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pink Esthetic Score (PES)	Pink esthetics	6 months
White Esthetic Score (WES)	White esthetics	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2017
• Primary Completion (ANTICIPATED): April 1, 2018
• Study Completion (ANTICIPATED): April 1, 2018

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: July 14, 2017
• First Posted (ACTUAL): July 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2017
• Last Update Submitted That Met QC Criteria: July 14, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Lithium Carbonate
• Other Study ID Numbers: PES/WES Vita Enamic

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