NCT03696849

Brief Summary

It is believed that final glazing yields the most acceptable ceramic surfaces in terms of smoothness. However, since reglazing must be performed in a dental laboratory with the use of a thermal furnace, it requires multiple office visits. Repeated firings have a destructive effect on ceramic surfaces and can cause deformation. Conversely, polishing is easy and simple and can be accomplished in a single session.

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
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 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

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
27 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

October 5, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

October 2, 2018

Last Update Submit

October 3, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Antagonists enamel wear using profilometer

    wear of enamel antagonists opposing to emaxPress crowns that will be measured in um

    1 year

Secondary Outcomes (2)

  • Restoration surface Roughness using profilometer

    1 year

  • Patient satisfaction

    1 year

Study Arms (2)

glazed emax Press

ACTIVE COMPARATOR
Other: polished emax Press

Polished emax Press

EXPERIMENTAL
Other: polished emax Press

Interventions

lithium disilicate glass ceramic crowns subjected to polishing only

Also known as: emaxPressable ceramics
Polished emax Pressglazed emax Press

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients from 18-50 years old who are able to read and sign the informed consent document.
  • Physically and psychologically able to tolerate conventional restorative procedures.
  • Have no active periodontal or pulpal diseases, have teeth with good restorations.
  • Patients have no temporomandibular disorders.
  • Each participant needed a crown on either a first or second premolar or first or second molar in any arch.
  • Teeth selected shoud include:
  • restorability with a crown:root ratio of at least 1:1. presence of an opposing natural tooth which was non-restored or minimally restored.
  • the presence of two non-restored or minimally restored teeth opposing each other on the same quadrants as the crowned tooth and the opposing to serve as enamel controls. Minimally restored was defined as teeth which have no restoration greater than a Class II amalgam restoration.
  • \- Willing to return for follow-up examinations and evaluation.

You may not qualify if:

  • Patients in the growth stage with partially erupted teeth.
  • Patients with poor oral hygiene and motivation.
  • Pregnant women.
  • Psychiatric problems or unrealistic expectations.
  • Lack of opposite occluding dentition in the area intended for restoration.
  • Patients with temporomandibular disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Central Study Contacts

Mervat Rouchdy, M.D.s

CONTACT

Lamia Khair Allah

CONTACT

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
assisstant lecturer, fixed prosthodontics department, faculty of oral and dental medicine

Study Record Dates

First Submitted

October 2, 2018

First Posted

October 5, 2018

Study Start

November 1, 2018

Primary Completion

November 1, 2019

Study Completion

January 1, 2020

Last Updated

October 5, 2018

Record last verified: 2018-10