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

One-year Clinical Assessment of Indirect Restorations Fabricated From Nano Hybrid Composite Blocks Versus Ceramic Blocks in Badly Broken Teeth (Randomized Clinical Trial)

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

Study Overview

• Status: Unknown
• Conditions: the Clinical Performance of Indirect Restoration Fabricated From Nanohybrid Cad Cam Composite Blocks and Ceramic Blocks
• Intervention / Treatment: Other: grandio blocks; Other: emax

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 Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Cairo University
    • Contact: omar MO shallan, phd; Phone Number: 01122665661

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
marginal integrity	Modified USPH criteria	one year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: shereen MO Hafez, phd, Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ANTICIPATED): August 1, 2019
• Study Completion (ANTICIPATED): September 1, 2019

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 22, 2019
• First Posted (ACTUAL): April 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 22, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: OPER-607

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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