Hybrid Crowns on Single Implants in Esthetic ZoneNCT03333889
Patient Satisfaction and Crestal Bone Loss of Polymer Infiltrated Ceramic Network Versus Lithium Disilicate Implant Hybrid Abutment Crowns in Esthetic Zone
A study testing Vita Enamic hybrid crown and emax hybrid crown in people with Hybrid Crowns on Single Implants in Esthetic Zone, run by Cairo University at 1 site in Egypt.
Trial summary
P: Population: Patients requiring single unit implant restoration in esthetic zone I: Intervention: Polymer-infiltrated-ceramic-network abutment crown (VITA Enamic-VITA Zahnfabrik) C: Comparison: Lithium disilicate ceramic abutment crown (IPS e. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hybrid Crowns on Single Implants in Esthetic Zone
- What is being tested?
- Vita Enamic hybrid crown and emax hybrid crown
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2018to Apr 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients above 18 years old.
- Patients able to read and sign the informed consent document.
- Medically free patients or with controlled systemic disease.
- Patients with good bone quality and quantity evaluated using C.B.C.T.
- Patients willing to return for follow-up examinations and evaluation.
- Patients having single missing recently extracted premolar tooth.
Who cannot join
- Young patients in growth stage.
- Patients with unsuitable implantation sites (patients with major boney defects or sever bone resorption)
- Pregnant women to avoid any complication that may occur in dental office.
- Patients with uncontrolled systemic disease (hypertensive patient or uncontrolled diabetic patient)
- Psychiatric problems or unrealistic expectations.
- Multiple adjacent missing teeth.
- Patients with bad oral hygiene. -
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Inas adel mahmoud
Cairo
inas Mahmoud, assistant leturer, 01008402645, inas.adel@dentistry.cu.edu.eg
Reham El Basty, lecturer, 01207169671, Reham.elbasty@dentistry.cu.edu.eg
About this study
P: Population: Patients requiring single unit implant restoration in esthetic zone I: Intervention: Polymer-infiltrated-ceramic-network abutment crown (VITA Enamic-VITA Zahnfabrik) C: Comparison: Lithium disilicate ceramic abutment crown (IPS e. max-Ivoclar Vivadent) O: Outcome: patient satisfaction , crestal bone loss and periodontal parameters T: Time: 12 months S :Randomized controlled trial research question:For patients receiving implants in esthetic zone, Does the use of polymer-infiltrated-ceramic-network hybrid abutment crown offer better patient satisfaction , less bone loss and better peri-implant clinical parameters when compared to lithium disilicate hybrid abutment crowns?
- Being tested
- Vita Enamic hybrid crown, emax hybrid crown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vita Enamic hybrid crownOther
hybrid ceramic material in the form of mesoblocks where the ceramic block is attached to a ti base .The whole assembly is screw retained superstructure.
emax hybrid crownOther
high srength glass ceramic that can be milled in sections up to 1mm .
| Study group | Role | What they receive |
|---|---|---|
| E-max hybrid crown | Active comparator | E-max hybrid crown Lithium Disilicate based ceramic which is characterized by high strength and optimum esthetics and considered a gold standard in anterior restorations Receives: Other: emax hybrid crown |
| Vita Enamic hybrid crown | Experimental | Vita Enamic hybrid crown polymer infilltrated ceramic network(hybrid ceramic) characterized by low modulus of elasticity that acts as cushion on implants. Receives: Other: Vita Enamic hybrid crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
using visual analogue scale (o-unsatisfied up to max 10 satisfied)
Measured: 12 months
Secondary outcomes (1)
crestal bone loss
using digital subtraction technique
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study startJan 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hybrid Crowns on Single Implants in Esthetic ZoneStudies 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, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inas Adel Mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333889
- Sponsor's protocol ID
- CEBD-CU-2017-11-02
- Status last verified
- Nov 2017
- First submitted
- 2 Nov 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Crestal Bone Loss of Polymer Infiltrated Ceramic Network Versus Lithium Disilicate Implant Hybrid Abutment Crowns in Esthetic Zone
- ClinicalTrials.gov ID
- NCT03333889
- Acronym / sponsor ID
- CEBD-CU-2017-11-02
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 7 Nov 2017 (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.
P: Population: Patients requiring single unit implant restoration in esthetic zone I: Intervention: Polymer-infiltrated-ceramic-network abutment crown (VITA Enamic-VITA Zahnfabrik) C: Comparison: Lithium disilicate ceramic abutment crown (IPS e. max-Ivoclar Vivadent) O: Outcome: patient satisfaction , crestal bone loss and periodontal parameters T: Time: 12 months S :Randomized controlled trial research question:For patients receiving implants in esthetic zone, Does the use of polymer-infiltrated-ceramic-network hybrid abutment crown offer better patient satisfaction , less bone loss and better peri-implant clinical parameters when compared to lithium disilicate hybrid abutment crowns?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-max hybrid crown | Active comparator | Other: emax hybrid crownE-max hybrid crown Lithium Disilicate based ceramic which is characterized by high strength and optimum esthetics and considered a gold standard in anterior restorations |
| Vita Enamic hybrid crown | Experimental | Other: Vita Enamic hybrid crownVita Enamic hybrid crown polymer infilltrated ceramic network(hybrid ceramic) characterized by low modulus of elasticity that acts as cushion on implants. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients above 18 years old.
- Patients able to read and sign the informed consent document.
- Medically free patients or with controlled systemic disease.
- Patients with good bone quality and quantity evaluated using C.B.C.T.
- Patients willing to return for follow-up examinations and evaluation.
Key exclusion criteria (7 listed)
- Young patients in growth stage.
- Patients with unsuitable implantation sites (patients with major boney defects or sever bone resorption)
- Pregnant women to avoid any complication that may occur in dental office.
- Patients with uncontrolled systemic disease (hypertensive patient or uncontrolled diabetic patient)
- Psychiatric problems or unrealistic expectations.
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 |
|---|---|---|
| Vita Enamic hybrid crownhybrid ceramic material in the form of mesoblocks where the ceramic block is attached to a ti base .The whole assembly is screw retained superstructure. | Other | Vita Enamic hybrid crown |
| emax hybrid crownhigh srength glass ceramic that can be milled in sections up to 1mm . | Other | E-max hybrid crown |
Primary outcome
patient satisfaction
Time frame: 12 months
using visual analogue scale (o-unsatisfied up to max 10 satisfied)
1 secondary outcome
crestal bone loss
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vita Enamic hybrid crown and emax hybrid crown in people with Hybrid Crowns on Single Implants in Esthetic Zone, 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 6 inclusion and 7 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 7 Nov 2017. 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 Inas Mahmoud, assistant lecturer (+201008402645, inas.adel@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction (time frame: 12 months). 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 7 Nov 2017.