NCT03220321

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

8 months

First QC Date

July 14, 2017

Last Update Submit

July 14, 2017

Conditions

Dental Implants

Outcome Measures

Primary Outcomes (2)

  • Pink Esthetic Score (PES)

    Pink esthetics

    6 months

  • White Esthetic Score (WES)

    White esthetics

    6 months

Study Arms (2)

IPS e.max hybrid abutment crown

ACTIVE COMPARATOR
Other: Lithium disilicate (IPS e.max) hybrid abutment crown

VITA Enamic hybrid abutment crown

EXPERIMENTAL
Other: PICN (VITA Enamic) hybrid abutment crown

Interventions

PICN (VITA Enamic) hybrid abutment crownOTHER

Hybrid ceramic

VITA Enamic hybrid abutment crown
Lithium disilicate (IPS e.max) hybrid abutment crownOTHER

Glass ceramic

IPS e.max hybrid abutment crown

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

VITA Enamiclithia disilicate

Central Study Contacts

Nourhan Elrifaie, B.D.S.

CONTACT

00201227473630nourhanelrifaie@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

July 14, 2017

First Posted

July 18, 2017

Study Start

August 1, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

July 18, 2017

Record last verified: 2017-07