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Comparing Nano Hybrid Composite Blocks With Ceramic Blocks in Indirect Restorations 2. Protocol Registration:

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926676
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Hamsa Ashraf Abd El Menam, Cairo University

Brief Summary:
comparing nano hybrid composite blocks grandio blocks (VOCO) with ceramic blocks (Emax) in indirect restorations using modified USPH criteria (marginal integrity) to see if there will be a significant different between two blocks

Condition or disease Intervention/treatment Phase
the Clinical Performance of Indirect Restoration Fabricated From Nanohybrid Cad Cam Composite Blocks and Ceramic Blocks Other: grandio blocks Other: emax Not Applicable

Detailed Description:

Ceramic restorations are well - thought- out an excellent option to restore posterior teeth were esthetics is required and the size of the cavity preparation has surpassed the conventional for direct resin composites , Ceramic systems can syndicate esthetics with wear resistance , being considered a consistent treatment of choice ,peutzfeld evaluated , the failure rate of different restorative materials used in posterior teeth and stated that gold inlays didnt present a much lower failure rate than ceramic or composite inlays, consequently , the author suggested that other aspects besides longevity , such as esthetics , charge and number of visits should also be considered when relating treatment options

Different ceramic systems for constructing inlays and onlays restorations are available in the market, some of the ceramic restorations are made using feldspathic ceramic , the Cerec computer aided design/computer -aided manufacturing, CAD/CAM system or the hot-pressed leucite -reinforced ceramic fabricated by the conventional lost wax technique , other systems that employ alumina are available , there are three types of materials available for the dentist (glass ceramics /ceramics)resin hybrid ceramics and composite blocks Advantages of ceramic restortations are improved because of their increased translucency and light transmission ,Another advantage embraces minimal tooth reduction compared with metal ceramics , minimal thermal conductivity , they have desirable properties including their physical and mechanical properties , outstanding biocompatbility to periodontal tissues and less susceptibility to metal allergies though ceramic blocks will cause wear of opposing natural teeth ,expensive , that's why we have to shift to another material resin composite Resin composite materials have been quickly developed in the last few years , direct resin composite restorations become the gold standard for restoring intra coronal cavities , while for the extra coronal cavities , the indirect resin composite onlays be inclined to replace metallic restorations in most situations being more esthetics and conservative with lower cost.

One of the break throughs in resin composite technology is the evolution of the new resin composite blocks (Grandio blocks ) merits of grandio blocks the highest fillers content ( 86% by weight)resembles natural teeth perfectly , excellent physical values for flexural strength and abrasion , no firing required (a real one step), can be processed using any conventional milling unit , can be polished and repaired optimally , Ideal for grinding even incases with thin edges and its based on the nano hybrid technology .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: One-year Clinical Assessment of Indirect Restorations Fabricated From Nano Hybrid Composite Blocks Versus Ceramic Blocks in Badly Broken Teeth (Randomized Clinical Trial)
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: Grandio blocks
Nano hybrid composite blocks
Other: grandio blocks
nano hybrid composite blocks

Other: emax
ceramic blocks

Active Comparator: E max
ceramic blocks
Other: grandio blocks
nano hybrid composite blocks

Other: emax
ceramic blocks




Primary Outcome Measures :
  1. marginal integrity [ Time Frame: one year ]
    Modified USPH criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients with badly broken vital teeth

good oral hygiene measures

young adults males or females

cooperative patients approving to participate in the study

Exclusion Criteria:

  • patients with compromised medical history

lack of compliance

severe medical condition

severe or active periodontal disease


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926676


Contacts
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Contact: donia MA abd el moaty, bachelor 01220767085 doniamahmoud17@gmail.com
Contact: aya MO adly, bachelor 01221528843 adly_sweetdentist@hotmail.com

Locations
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Egypt
Cairo University Recruiting
Giza, Egypt
Contact: omar MO shallan, phd    01122665661      
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: shereen MO Hafez, phd Cairo University
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Responsible Party: Hamsa Ashraf Abd El Menam, Cairo University
ClinicalTrials.gov Identifier: NCT03926676    
Other Study ID Numbers: OPER-607
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No