NCT03298152

Brief Summary

Nowadays Endocrowns are classified as conservative treatment modality for restoration of Endodontically treated teeth in which pulp chamber is used as a retentive resource. With the advancement in technology in the field of adhesive dentistry its use is increasing day by day in clinical practice. Acid Etchable ceramics such as lithium Disilicate based ceramics are the gold standard ceramic material used for Endocrowns. The Etchable property and the translucent character of lithium Disilicate enhance strength and esthetic property. A new material CERASMART (Force Absorbing Flexible nano ceramic CAD/CAM block) contain high density of ultrafine glass particles with 71 wt% filled nano-composite. It combines high strength and unique aesthetics. full homogeneous and even distribution of nano ceramic network lead to unique physical properties for cerasmart . Uniform scuttle (very short inter-particle distance) of silanated and bonded particles is key to delivering CERASMART's™ with high strength and acceptable level of marginal adaptation. So, it can perfectly use in posterior, anterior, inlay, onlay, and implant restorations and also enables minimum tooth reduction for more conservative restoration. Awad et al (1) found that Cerasmart showed significantly higher flexural strength and modulus of elasticity, with lower flexural modulus values compared to other groups. Also, result in smoother margins compared with other types of ceramic. So, present research will evaluate patient satisfaction, bonding properties and marginal adaptation

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

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

September 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

2 months

First QC Date

September 27, 2017

Last Update Submit

October 10, 2017

Conditions

Keywords

lithium disilicate endocrownscerasmart endocrowns

Outcome Measures

Primary Outcomes (1)

  • Gross Fracture

    Categorical Alpha (A): Restoration is intact and fully retained. Bravo (B): Restoration is partially retained with some parts of the restoration still intact. Charlie (C): Restoration is completely missing

    one year

Secondary Outcomes (2)

  • Patient satisfaction

    one year

  • Marginal Integrity

    one year

Study Arms (2)

Emax CAD Endocrowns

ACTIVE COMPARATOR

Using lithium disilicate e.max restorations is documented in literature as a successful restoration. Two different ceramic crowns systems were investigated clinically for three-years and howed that patient was satisfied with the final restoration

Procedure: Emax Endocrown

Cerasmart Endocrowns

EXPERIMENTAL

A new material CERASMART (Force Absorbing Flexible nano ceramic CAD/CAM block) with high density of ultrafine glass particles with 71 wt% filled nano-composite. It combines high strength and unique aesthetics. full homogeneous and even distribution nano ceramic network lead to unique physical properties for cerasmart . Uniform scuttle (very short inter-particle distance) of silanated and bonded particles is key to delivering CERASMART's™ with exceptional strength, retention, acceptable level of marginal adaptation

Procedure: CERASMART Endocrown

Interventions

Endocrown fixed restoration used to restore endodontically treated anterior teeth using CERASMART blocks

Cerasmart Endocrowns

Endocrown fixed restoration used to restore endodontically treated anterior teeth using Emax material

Emax CAD Endocrowns

Eligibility Criteria

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

You may qualify if:

  • \- 1. Age range of the patients from 20-60 years old who can read and sign informed consent document.
  • \. Medically free patients or with controlled systemic disease. 3. No active periodontal disease.

You may not qualify if:

  • \- 1. Patients under 20 years old. 2. Patients with bad oral hygiene and motivation. 3. Patients with psychiatric problems or unrealistic expectation (patient have phobia from dental treatments or needle bricks).
  • \. Patients with parafunctional habits (clencing/bruxism).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, Egypt

Location

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Central Study Contacts

Norhan Abd El Haliem, MDs

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 2, 2017

Study Start

December 1, 2017

Primary Completion

February 1, 2018

Study Completion

April 1, 2019

Last Updated

October 12, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations