Prosthesis SurvivalNCT02941575
Patient Satisfaction and Peri-Implant Tissue Success of Hybrid Ceramic Versus E-Max Superstructures
A study testing Crystal Ultra and All ceramic in people with Prosthesis Survival, run by Cairo University.
Trial summary
In patients receiving implants in the esthetic zone, would the use of new Nano hybrid ceramic crown material (Crystal Ultra) improve esthetic patient satisfaction and peri-implant tissue success when compared with Lithium Disilicate crown (E-max)? Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis Survival
- What is being tested?
- Crystal Ultra and All ceramic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to May 2018
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age above 18 years with at least one tooth missing in the esthetic area.
- Available bone for implant placement:
- Labial and Palatal Plate of bone not less than 2mm. B. Mesio- distal dimension not less than 6.5mm. C. Bone length not less than 9mm.
- Patient with good oral hygiene.
- Class 1 occlusion.
- Lack of excessive parafunctional activity leading to implant failure.
- Tooth extracted not less than 6 month.
Who cannot join
- Young patients in whom the jaws are still growing. (Less than 18 years).
- Jaw pathology.
- Smokers.
- Uncontrolled Diabetic or particularly insulin-dependent.
- Radiotherapy to the neck or face.
- Multiple loss of teeth which may be indicated for more complicated procedure.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Esthetic Patient Satisfaction and Peri-Implant Tissue Success of Crystal Ultra Hybrid Ceramic Compared to E-Max Superstructures in Esthetic Zone
In patients receiving implants in the esthetic zone, would the use of new Nano hybrid ceramic crown material (Crystal Ultra) improve esthetic patient satisfaction and peri-implant tissue success when compared with Lithium Disilicate crown (E-max)?
Read the detailed description
The patient will be treated in visits designated as follows:
Visit 1: Preoperative records, face-to-face adherence reminder session, signing consents, clinical, radiographic examination and primary impression for diagnostic cast construction.
Visit 2: (first stage surgery): implant placement surgical procedure and postoperative radiograph.
Visit 3: After 3months (second stage surgery): re-opening of surgical site, placement of healing abutments and temporary crowns.
Visit 4: After 2 weeks, removing of temporary restorations and taking of final impressions Visit 5: placement of different ceramic crown superstructures and recording different outcome values.
- Conditions
- Prosthesis Survival
- Being tested
- Crystal Ultra, All ceramic
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crystal UltraOther
Also called hybrid ceramics, resin nanoceramic e.g Cerasmart
Crystal Ultra: is a resin nano-ceramic material, that combines both advantages of ceramics and composites.
All ceramicOther
Also called IPS-Emax, all ceramic crowns
IPS Emax: is an all ceramic crown that has proven superior aesthetics and strength properties.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Implant superstructure crown: All ceramic, IPS Emax Receives: Other: All ceramic |
| Intervention | Experimental | Implant superstructure crown: Hybrid ceramic, crystal Ultra crown Receives: Other: Crystal Ultra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esthetic Patient satisfaction
Measurement unit is Binary
Measured: 1 year
Secondary outcomes (1)
Peri-implant tissue success (A-Marginal Bone Loss, B-Relative attachment level, C-Peri-Implant Probing depth, D-Sulcus bleeding)
Measurement unit is Categorical
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionMar 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis SurvivalStudies 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
- Care provider, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Samir Bushra, Cairo University
- Investigators
- Jylian El Guindy, Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941575
- Sponsor's protocol ID
- CEBD-CU-2016-09-215
- Status last verified
- Oct 2016
- First submitted
- 18 Oct 2016
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthetic Patient Satisfaction and Peri-Implant Tissue Success of Crystal Ultra Hybrid Ceramic Compared to E-Max Superstructures in Esthetic Zone
- ClinicalTrials.gov ID
- NCT02941575
- Acronym / sponsor ID
- CEBD-CU-2016-09-215
- Conditions
- Prosthesis Survival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 21 Oct 2016 (estimated)
- 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.
In patients receiving implants in the esthetic zone, would the use of new Nano hybrid ceramic crown material (Crystal Ultra) improve esthetic patient satisfaction and peri-implant tissue success when compared with Lithium Disilicate crown (E-max)?
Detailed description
The patient will be treated in visits designated as follows:
Visit 1: Preoperative records, face-to-face adherence reminder session, signing consents, clinical, radiographic examination and primary impression for diagnostic cast construction.
Visit 2: (first stage surgery): implant placement surgical procedure and postoperative radiograph.
Visit 3: After 3months (second stage surgery): re-opening of surgical site, placement of healing abutments and temporary crowns.
Visit 4: After 2 weeks, removing of temporary restorations and taking of final impressions Visit 5: placement of different ceramic crown superstructures and recording different outcome values.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: All ceramicImplant superstructure crown: All ceramic, IPS Emax |
| Intervention | Experimental | Other: Crystal UltraImplant superstructure crown: Hybrid ceramic, crystal Ultra crown |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age above 18 years with at least one tooth missing in the esthetic area.
- Available bone for implant placement:
- Patient with good oral hygiene.
- Class 1 occlusion.
- Lack of excessive parafunctional activity leading to implant failure.
Key exclusion criteria (6 listed)
- Young patients in whom the jaws are still growing. (Less than 18 years).
- Jaw pathology.
- Smokers.
- Uncontrolled Diabetic or particularly insulin-dependent.
- Radiotherapy to the neck or face.
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 |
|---|---|---|
| Crystal UltraAlso: hybrid ceramics, resin nanoceramic e.g CerasmartCrystal Ultra: is a resin nano-ceramic material, that combines both advantages of ceramics and composites. | Other | Intervention |
| All ceramicAlso: IPS-Emax, all ceramic crownsIPS Emax: is an all ceramic crown that has proven superior aesthetics and strength properties. | Other | Control |
Primary outcome
Esthetic Patient satisfaction
Time frame: 1 year
Measurement unit is Binary
1 secondary outcome
Peri-implant tissue success (A-Marginal Bone Loss, B-Relative attachment level, C-Peri-Implant Probing depth, D-Sulcus bleeding)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Jylian El Guindy, Professor principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Crystal Ultra and All ceramic in people with Prosthesis Survival, run by Cairo University.
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 7 inclusion and 6 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 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Sherif Bushra (01224029053, sherifsamir3000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esthetic Patient satisfaction (time frame: 1 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 21 Oct 2016; AzTrials last refreshed its copy on 8 Nov 2026.