NCT03697018

Brief Summary

evaluation of wear behavior and patient satisfaction of monolithic zirconia and zirconia reinforced glass crowns after follow-up periods 0,3,6,12 months.

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
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

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

Study Start

First participant enrolled

October 1, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

October 2, 2018

Last Update Submit

October 5, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • wear of the antagonist natural enamel

    loss of opposing tooth structure which will be measured by 3D Profilometer

    from baseline till one year

Secondary Outcomes (1)

  • patient satisfaction

    from baseline till one year

Study Arms (2)

zirconia reinforced lithium silicate glass ceramic

EXPERIMENTAL

It represent a new generation of glass ceramic material, enriched with zirconia (10% by weight), the material offers natural esthetics with successful outcome.

Other: zirconia reinforced lithium silicate glass ceramic

monolithic zirconia

ACTIVE COMPARATOR

Zirconia or zirconium dioxide (ZrO2) is a highly attractive ceramic material in prosthodontics due to its excellent mechanical properties. It is widely used to build prosthetic devices.

Other: zirconia reinforced lithium silicate glass ceramic

Interventions

It represent a new generation of glass ceramic material. Using an innovative manufacturing process the glass ceramic is enriched with zirconia (10% by weight) for dental CAD/CAM applications for the fabrication of inlays, onlays, crowns and anterior and posterior single tooth restorations on implant abutments.

monolithic zirconiazirconia reinforced lithium silicate glass ceramic

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient age range from 20-60 to be able to read and write in order to sign the informed consent document.
  • Patients physically and psychologically able to tolerate conventional restorative procedures.
  • Patients with no active periodontal and or pulpal diseases, having teeth with good restorations.
  • Patients with root canal treated teeth requiring full coverage restorations.
  • Patients indicated for full coverage (e.g. moderate to severe discoloration, coronal fracture, malposed or malformed teeth).
  • Patients willing to return for follow-up examinations and assessments

You may not qualify if:

  • Patients in the growth stage with partially erupted teeth.
  • Patient with poor oral hygiene.
  • Patients with psychiatric problems or unrealistic expectations
  • Patient with no opposite occluding dentition in the area intended for restoration.
  • Patient suffering from Para functional habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

esraa mohamed hany

CONTACT

hesham katamesh, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD candidate, fixed prosthodontic department, faculty of Oral and dental Medicine

Study Record Dates

First Submitted

October 2, 2018

First Posted

October 5, 2018

Study Start

October 1, 2018

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

October 9, 2018

Record last verified: 2018-10