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

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03926676

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 .

Study Design

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2019

Anticipated Primary Completion Date :

Aug 1, 2019

Anticipated Study Completion Date :

Sep 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

marginal integrity [one year]
Modified USPH criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Giza		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: shereen MO Hafez, phd, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hamsa Ashraf Abd El Menam, Hamsa Ashraf Abd El Menam, Cairo University

ClinicalTrials.gov Identifier:

NCT03926676

Other Study ID Numbers:

OPER-607

First Posted:

Apr 24, 2019

Last Update Posted:

Apr 24, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Apr 24, 2019