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Clinical Trials/NCT03298152
NCT03298152UnknownNot Applicable

One Year Clinical Evaluation of E-max CAD Versus Cerasmart Endocrowns in Anterior Endodontically Treated Teeth:A Randomized Clinical Trial

Cairo University1 site in 1 country32 target enrollmentStarted: December 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
32
Locations
1
Primary Endpoint
Gross Fracture

Study Overview

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

Detailed Description

This study will carried out on patients collected from the dental clinics in fixed prosthodontics clinic, Faculty of Dentistry, Cairo University

the visits will be designed as follows:

.1st visit: (N.N) will call participants before tooth preparation procedure for X-ray reviewing and pre-operative photographing using a Professional digital camera also; Impression will be taken using the alginate impression material * for study cast analysis with suitable stock tray** size.

Each participant will be asked to sign consent form written in patient native language.

2nd visit: (Tooth preparation) After performing adequate disinfection and sterilization process for each instrument and tools will be used in this trial; the anesthetic solution (Anesthetic solution: Septanest SP, 4%, Septodont, France.) will be injected using infiltration technique. Then patients will be left from five to ten minutes then; the operator will check with the subjective for anasthesia.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.
  • •No active periodontal disease.

Exclusion Criteria

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

Arms & Interventions

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

Intervention: Emax Endocrown (Procedure)

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

Intervention: CERASMART Endocrown (Procedure)

Outcomes

Primary Outcomes

Gross Fracture

Time Frame: one year

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

Secondary Outcomes

  • Patient satisfaction(one year)
  • Marginal Integrity(one year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Norhan Naief Abd El Haliem

assistant lecturer

Cairo University

Study Sites (1)

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