Tooth LossNCT03521024
Effect of Zirconia Implant Supported PEKK Crowns Versus Lithium Disilicate Crowns on Esthetics
A study testing poly ether ketone ketone and lithium disilicate in people with Tooth Loss, run by Cairo University.
Trial summary
aim of study is to evaluate esthetic and biomechanical outcome of maxillary anterior single-tooth zirconia implant supported PEKK crowns compared to lithium disilicate crowns on PEKK abutments . Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- poly ether ketone ketone and lithium disilicate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2018to 15 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age >18 years
- No active intraoral or systemic disease
- No pregnancy or lactation
- controlled periodontal conditions
- Adequate bone volume to place an implant
- Occlusal function with a natural tooth
Who cannot join
- Current pregnancy.
- Psychiatric disorders.
- Smokers
- Poor motivation.
- Several occlusal parafunction.
- Persistent intraoral infections.
Show all 10Show fewer
- Severe mucosal disease.
- Active periodontitis.
- Poor oral hygiene.
- Lack of occluding dentition at implant rehabilitation level
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Esthetic and Biomechanical Outcome of Maxillary Anterior Single-Tooth Zirconia Implant Supported PEKK Crowns Versus Lithium Disilicate Crowns on PEKK Abutments: Randomized Controlled Trial
aim of study is to evaluate esthetic and biomechanical outcome of maxillary anterior single-tooth zirconia implant supported PEKK crowns compared to lithium disilicate crowns on PEKK abutments .
Read the detailed description
High performance polymers may be a valid alternative to other conventional materials for abutments and crowns over zirconia implants because of their cushioning effect and elastic modulus (5.1GPa), which absorb occlusal forces and avoid overload of the underlying bone from the direct transmission of biting impacts ; which could optimize and preserve osseointegration with time. Zirconia implants with high performance polymers restorations can be considered a good alternative for replacing natural teeth.
For many years lithium disilicate has been the esthetics standard used in Veneers ,Inlays , onlays, occlusal veneers, partial crowns,minimally invasive crowns and Implant superstructures due to its natural-looking tooth colouring and excellent light-optical properties.
Due to the promising esthetics of high performance polymers as it can be veneered with different veneering materials it would successfully restore esthetics.
- Conditions
- Tooth Loss
- Being tested
- poly ether ketone ketone, lithium disilicate
- Keywords
- Zirconia implants, PEKK crowns, high performance polymer crowns
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
poly ether ketone ketoneOther
Polyetherketoneketone (PEKK) forms a group of high-performance thermoplastic polymers. PEKK shows excellent biocompatibility and exhibits outstanding properties such as high wear resistance and high compressive (246 MPa), flexural (5.0GPa), and tensile strengths (115 MPa). The material is lightweight, allows shock absorption, and can be veneered with various commercially available dental materials
lithium disilicateOther
well documented in the literatures as successful restoration modality.
| Study group | Role | What they receive |
|---|---|---|
| lithium disilicate crowns | Active comparator | lithium disilicate crowns are well documented in the literatures as successful restoration modality. Receives: Other: poly ether ketone ketone; Other: lithium disilicate |
| poly ether ketone ketone crowns | Experimental | pekkton Receives: Other: poly ether ketone ketone; Other: lithium disilicate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esthetic outcome
measured by pink and white esthetics score
Measured: 9 month
Secondary outcomes (1)
bone resorption
measured by CBCT and measuring unit Housfield Unit(HU)
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start15 Sep 2018 (estimated)
- Primary completion15 Jun 2019 (estimated)
- Study completion15 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies 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
- Model description
- Patient will receive a restoration with superior function, esthetics, and quality.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamiaa Said Zaki AbdelSalam Elfadaly, Cairo University
- Investigators
- Lamiaa Abdelsalam, MSc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521024
- Sponsor's protocol ID
- Lamiaa Said Zaki Abd ElSalam
- Status last verified
- May 2018
- First submitted
- 26 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- 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 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Esthetic and Biomechanical Outcome of Maxillary Anterior Single-Tooth Zirconia Implant Supported PEKK Crowns Versus Lithium Disilicate Crowns on PEKK Abutments: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03521024
- Acronym / sponsor ID
- Lamiaa Said Zaki Abd ElSalam
- Conditions
- Tooth Loss
- Keywords
- Zirconia implants, PEKK crowns, high performance polymer crowns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2018 (estimated)
- Primary completion
- 15 Jun 2019 (estimated)
- Study completion
- 15 Sep 2019 (estimated)
- First posted
- 11 May 2018 (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.
aim of study is to evaluate esthetic and biomechanical outcome of maxillary anterior single-tooth zirconia implant supported PEKK crowns compared to lithium disilicate crowns on PEKK abutments .
Detailed description
High performance polymers may be a valid alternative to other conventional materials for abutments and crowns over zirconia implants because of their cushioning effect and elastic modulus (5.1GPa), which absorb occlusal forces and avoid overload of the underlying bone from the direct transmission of biting impacts ; which could optimize and preserve osseointegration with time. Zirconia implants with high performance polymers restorations can be considered a good alternative for replacing natural teeth.
For many years lithium disilicate has been the esthetics standard used in Veneers ,Inlays , onlays, occlusal veneers, partial crowns,minimally invasive crowns and Implant superstructures due to its natural-looking tooth colouring and excellent light-optical properties.
Due to the promising esthetics of high performance polymers as it can be veneered with different veneering materials it would successfully restore esthetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patient will receive a restoration with superior function, esthetics, and quality.
| Arm | Type | Receives |
|---|---|---|
| lithium disilicate crowns | Active comparator | Other: poly ether ketone ketone, Other: lithium disilicatelithium disilicate crowns are well documented in the literatures as successful restoration modality. |
| poly ether ketone ketone crowns | Experimental | Other: poly ether ketone ketone, Other: lithium disilicatepekkton |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age >18 years
- No active intraoral or systemic disease
- No pregnancy or lactation
- controlled periodontal conditions
- Adequate bone volume to place an implant
Key exclusion criteria (10 listed)
- Current pregnancy.
- Psychiatric disorders.
- Smokers
- Poor motivation.
- Several occlusal parafunction.
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 |
|---|---|---|
| poly ether ketone ketonePolyetherketoneketone (PEKK) forms a group of high-performance thermoplastic polymers. PEKK shows excellent biocompatibility and exhibits outstanding properties such as high wear resistance and high compressive (246 MPa), flexural (5.0GPa), and tensile strengths (115 MPa). The material is lightweight, allows shock absorption, and can be veneered with various commercially available dental materials | Other | lithium disilicate crowns, poly ether ketone ketone crowns |
| lithium disilicatewell documented in the literatures as successful restoration modality. | Other | lithium disilicate crowns, poly ether ketone ketone crowns |
Primary outcome
Esthetic outcome
Time frame: 9 month
measured by pink and white esthetics score
1 secondary outcome
bone resorption
Time frame: 9 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Lamiaa Abdelsalam, MSc principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing poly ether ketone ketone and lithium disilicate in people with Tooth Loss, 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 10 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 11 May 2018. 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 lamiaa Abdelsalam, MSc (201015833015, dr.l.fadaly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esthetic outcome (time frame: 9 month). 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 11 May 2018.