the Clinical Performance of Indirect Restoration Fabricated From Nanohybrid Cad Cam Composite Blocks and Ceramic BlocksNCT03926676
Comparing Nano Hybrid Composite Blocks With Ceramic Blocks in Indirect Restorations 2. Protocol Registration:
A study testing grandio blocks and emax in people with the Clinical Performance of Indirect Restoration Fabricated From Nanohybrid Cad Cam Composite Blocks and Ceramic Blocks, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- the Clinical Performance of Indirect Restoration Fabricated From Nanohybrid Cad Cam Composite Blocks and Ceramic Blocks
- What is being tested?
- grandio blocks and emax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with badly broken vital teeth
- good oral hygiene measures
- young adults males or females
- cooperative patients approving to participate in the study
Who cannot join
- patients with compromised medical history
- lack of compliance
- severe medical condition
- severe or active periodontal disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Giza
omar MO shallan, phd, 01122665661
About this study
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)
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
Read the 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 .
- Being tested
- grandio blocks, emax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
grandio blocksOther
nano hybrid composite blocks
emaxOther
ceramic blocks
| Study group | Role | What they receive |
|---|---|---|
| Grandio blocks | Experimental | Nano hybrid composite blocks Receives: Other: grandio blocks; Other: emax |
| E max | Active comparator | ceramic blocks Receives: Other: grandio blocks; Other: emax |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal integrity
Modified USPH criteria
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start1 Jan 2019
- Primary completionAug 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Clinical Performance of Indirect Restoration Fabricated From Nanohybrid Cad Cam Composite Blocks and Ceramic BlocksStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamsa Ashraf Abd El Menam, Cairo University
- Investigators
- shereen MO Hafez, phd, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926676
- Sponsor's protocol ID
- OPER-607
- Status last verified
- Apr 2019
- First submitted
- 22 Apr 2019
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03926676
- Acronym / sponsor ID
- OPER-607
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grandio blocks | Experimental | Other: grandio blocks, Other: emaxNano hybrid composite blocks |
| E max | Active comparator | Other: grandio blocks, Other: emaxceramic blocks |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients with badly broken vital teeth
- good oral hygiene measures
- young adults males or females
- cooperative patients approving to participate in the study
Key exclusion criteria (4 listed)
- patients with compromised medical history
- lack of compliance
- severe medical condition
- severe or active periodontal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| grandio blocksnano hybrid composite blocks | Other | E max, Grandio blocks |
| emaxceramic blocks | Other | E max, Grandio blocks |
Primary outcome
marginal integrity
Time frame: one year
Modified USPH criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shereen MO Hafez, phd principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing grandio blocks and emax in people with the Clinical Performance of Indirect Restoration Fabricated From Nanohybrid Cad Cam Composite Blocks and Ceramic Blocks, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact donia MA abd el moaty, bachelor (01220767085, doniamahmoud17@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
marginal integrity (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019; AzTrials last refreshed its copy on 1 Nov 2026.