Dental ImplantsNCT03220321
Pink and White Esthetic Scores of Polymer-infiltrated-ceramic-network and Lithium Disilicate Implant Hybrid Abutment Crowns
A study testing PICN (VITA Enamic) hybrid abutment crown and Lithium disilicate (IPS e.max) hybrid abutment crown in people with Dental Implants, run by Cairo University.
Trial summary
The aim of this study is to evaluate the effect of polymer-infiltrated-ceramic-network hybrid ceramic on pink and white esthetics in comparison with lithium disilicate. The research hypothesis is that there will be comparable clinical performance results between polymer-infiltrated-ceramic-network and lithium… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- What is being tested?
- PICN (VITA Enamic) hybrid abutment crown and Lithium disilicate (IPS e.max) hybrid abutment crown
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to Apr 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Literate, capable of reading and signing the informed consent document
- Healthy, free from or with controlled systemic disease
- With acceptable oral health to support implant restorations
- With good bone quality and quantity
- Cooperative, accepting follow up and maintenance sessions
- Having single missing tooth in esthetic zone
Who cannot join
- Under 18 years old
- Illiterate, unable of comprehending or signing the informed consent document
- Unhealthy with uncontrolled systemic disease
- Pregnancy
- With unfavorable oral state that might affect implant procedure and restoration
- Uncooperative, not willing to return for follow up visits
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pink and White Esthetic Scores of Polymer-infiltrated-ceramic-network and Lithium Disilicate Implant Hybrid Abutment Crowns: Randomized Clinical Trial
The aim of this study is to evaluate the effect of polymer-infiltrated-ceramic-network hybrid ceramic on pink and white esthetics in comparison with lithium disilicate.
The research hypothesis is that there will be comparable clinical performance results between polymer-infiltrated-ceramic-network and lithium disilicate hybrid abutment crowns.
- Conditions
- Dental Implants
- Being tested
- PICN (VITA Enamic) hybrid abutment crown, Lithium disilicate (IPS e.max) hybrid abutment crown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICN (VITA Enamic) hybrid abutment crownOther
Hybrid ceramic
Lithium disilicate (IPS e.max) hybrid abutment crownOther
Glass ceramic
| Study group | Role | What they receive |
|---|---|---|
| IPS e.max hybrid abutment crown | Active comparator | Not described Receives: Other: Lithium disilicate (IPS e.max) hybrid abutment crown |
| VITA Enamic hybrid abutment crown | Experimental | Not described Receives: Other: PICN (VITA Enamic) hybrid abutment crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pink Esthetic Score (PES)
Pink esthetics
Measured: 6 months
White Esthetic Score (WES)
White esthetics
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study startAug 2017 (estimated)
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Mohammed Elsaad Elrifaie, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220321
- Sponsor's protocol ID
- PES/WES Vita Enamic
- Status last verified
- Jul 2017
- First submitted
- 14 Jul 2017
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pink and White Esthetic Scores of Polymer-infiltrated-ceramic-network and Lithium Disilicate Implant Hybrid Abutment Crowns: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03220321
- Acronym / sponsor ID
- PES/WES Vita Enamic
- Conditions
- Dental Implants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 18 Jul 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.
The aim of this study is to evaluate the effect of polymer-infiltrated-ceramic-network hybrid ceramic on pink and white esthetics in comparison with lithium disilicate.
The research hypothesis is that there will be comparable clinical performance results between polymer-infiltrated-ceramic-network and 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 |
|---|---|---|
| IPS e.max hybrid abutment crown | Active comparator | Other: Lithium disilicate (IPS e.max) hybrid abutment crown |
| VITA Enamic hybrid abutment crown | Experimental | Other: PICN (VITA Enamic) hybrid abutment crown |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Literate, capable of reading and signing the informed consent document
- Healthy, free from or with controlled systemic disease
- With acceptable oral health to support implant restorations
- With good bone quality and quantity
- Cooperative, accepting follow up and maintenance sessions
Key exclusion criteria (6 listed)
- Under 18 years old
- Illiterate, unable of comprehending or signing the informed consent document
- Unhealthy with uncontrolled systemic disease
- Pregnancy
- With unfavorable oral state that might affect implant procedure and restoration
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 |
|---|---|---|
| PICN (VITA Enamic) hybrid abutment crownHybrid ceramic | Other | VITA Enamic hybrid abutment crown |
| Lithium disilicate (IPS e.max) hybrid abutment crownGlass ceramic | Other | IPS e.max hybrid abutment crown |
Primary outcome
Pink Esthetic Score (PES)
Time frame: 6 months
Pink esthetics
White Esthetic Score (WES)
Time frame: 6 months
White esthetics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Dental Implants
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
RecruitingObservational study
Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants
Dental Implants
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
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.
Questions about this trial
What is this clinical trial studying?
A study testing PICN (VITA Enamic) hybrid abutment crown and Lithium disilicate (IPS e.max) hybrid abutment crown in people with Dental Implants, 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 6 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 18 Jul 2017. 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 Nourhan Elrifaie, B.D.S. (00201227473630, nourhanelrifaie@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pink Esthetic Score (PES) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 18 Jul 2017.