NCT02941575

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)?

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
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

October 21, 2016

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

October 18, 2016

Last Update Submit

October 19, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Esthetic Patient satisfaction

    Measurement unit is Binary

    1 year

Secondary Outcomes (1)

  • Peri-implant tissue success (A-Marginal Bone Loss, B-Relative attachment level, C-Peri-Implant Probing depth, D-Sulcus bleeding)

    1 year

Study Arms (2)

Control

ACTIVE COMPARATOR

Implant superstructure crown: All ceramic, IPS Emax

Other: All ceramic

Intervention

EXPERIMENTAL

Implant superstructure crown: Hybrid ceramic, crystal Ultra crown

Other: Crystal Ultra

Interventions

Crystal Ultra: is a resin nano-ceramic material, that combines both advantages of ceramics and composites.

Also known as: hybrid ceramics, resin nanoceramic e.g Cerasmart
Intervention

IPS Emax: is an all ceramic crown that has proven superior aesthetics and strength properties.

Also known as: IPS-Emax, all ceramic crowns
Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age above 18 years with at least one tooth missing in the esthetic area.
  • 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.
  • Patient with good oral hygiene.
  • Class 1 occlusion.
  • Lack of excessive parafunctional activity leading to implant failure.
  • Tooth extracted not less than 6 month.

You may not qualify if:

  • Young patients in whom the jaws are still growing. (Less than 18 years).
  • Jaw pathology.
  • Smokers.
  • Uncontrolled Diabetic or particularly insulin-dependent.
  • Radiotherapy to the neck or face.
  • Multiple loss of teeth which may be indicated for more complicated procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jylian El Guindy, Professor

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

October 18, 2016

First Posted

October 21, 2016

Study Start

December 1, 2016

Primary Completion

March 1, 2018

Study Completion

May 1, 2018

Last Updated

October 21, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share