Single Posterior CrownsNCT03685513
One Year Clinical Evaluation of Milled BioHPP Polyetheretherketone (PEEK)-Based Versus Metal Ceramic Single Crowns
A study testing BioHPP PEEK-based single posterior crowns and Metal ceramic single posterior crowns in people with Single Posterior Crowns and Badly Decayed Teeth, Teeth Restored With Large Filling Restorations or Endodontically Treated Teeth, run by Cairo University.
Trial summary
Although the metal-ceramic system is still widely used to fabricate crowns and fixed partial dentures and is considered as the standard treatment in dentistry, aesthetic concerns have stimulated the development of new dental tooth-colored systems as PEEK. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Single Posterior Crowns, Badly Decayed Teeth, Teeth Restored With Large Filling Restorations or Endodontically Treated Teeth, Malformed Teeth, Malposed Teeth (Tilted, Over-erupted, Rotated, Etc.) or Spacing Between Posterior Teeth
- What is being tested?
- BioHPP PEEK-based single posterior crowns and Metal ceramic single posterior crowns
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 1 Jun 2020
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- From 18-50 years old, be able to read and sign the informed consent document.
- Have no active periodontal or pulpal diseases, have teeth with good restorations
- Psychologically and physically able to withstand conventional dental procedures
- Patients with teeth problems indicated for single posterior crowns:
- Badly decayed teeth
- Teeth restored with large filling restorations
Show all 11Show fewer
- Endodontically treated teeth
- Malformed teeth
- Malposed teeth (Tilted, over-erupted, rotated, etc.)
- Spacing between posterior teeth
- Able to return for follow-up examinations and evaluation
Who cannot join
- Patient less than 18 or more than 50 years
- Patient with active resistant periodontal diseases
- Patients with poor oral hygiene and uncooperative patients
- Pregnant women
- Patients in the growth stage with partially erupted teeth
- Psychiatric problems or unrealistic expectations
- Lack of opposing dentition in the area of interest
Trial locations and contacts
No sites are listed yet.
Amina Zaki contact
About this study
Although the metal-ceramic system is still widely used to fabricate crowns and fixed partial dentures and is considered as the standard treatment in dentistry, aesthetic concerns have stimulated the development of new dental tooth-colored systems as PEEK.
BioHPP PEEK is 20% ceramic reinforced, semicrystalline, thermoplastic and radiolucent polymer for extreme durability especially for frameworks for fixed and removable dental prostheses. It has many advantages as low density, light weight, shock absorber, biocompatible and venerable with composite resin.
The aim of this study is to evaluate the clinical performance of milled BioHPP PEEK-based single crowns and compare them to metal-based single crowns.
- Conditions
- Single Posterior Crowns, Badly Decayed Teeth, Teeth Restored With Large Filling Restorations or Endodontically Treated Teeth, Malformed Teeth, Malposed Teeth (Tilted, Over-erupted, Rotated, Etc.) or Spacing Between Posterior Teeth
- Being tested
- BioHPP PEEK-based single posterior crowns, Metal ceramic single posterior crowns
- Medical subject headings
- Tooth, Nonvital, Tooth Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioHPP PEEK-based single posterior crownsOther
BioHPP PEEK is 20% ceramic reinforced, semicrystalline, thermoplastic and radiolucent polymer for extreme durability especially for frameworks for fixed and removable dental prostheses. It has many advantages as low density, light weight, shock absorber, biocompatible and venerable with composite resin.
Metal ceramic single posterior crownsOther
Also called Porcelain fused to metal (PFM) or Ceramo-metallic
Standard metal coping veneered with glass ceramics
| Study group | Role | What they receive |
|---|---|---|
| Metal ceramic single posterior crowns | Active comparator | Metal copings veneered with feldspathic porcelain Receives: Other: Metal ceramic single posterior crowns |
| BioHPP PEEK-based single posterior crowns | Experimental | BioHPP PEEK copings veneered with composite resin Receives: Other: BioHPP PEEK-based single posterior crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture
Measured using modified USPHS criteria
Measured: 1 year
Secondary outcomes (1)
Marginal adaptation
Measured using modified USPHS criteria
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 posted26 Sep 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Posterior CrownsStudies 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Soliman Elsayed Badran, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685513
- Sponsor's protocol ID
- CEBD-CU-2018-09-30
- Status last verified
- Sep 2018
- First submitted
- 25 Sep 2018
- Last updated
- 26 Sep 2018
- 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 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Year Clinical Evaluation of Milled BioHPP Polyetheretherketone (PEEK)-Based Versus Metal Ceramic Single Crowns
- ClinicalTrials.gov ID
- NCT03685513
- Acronym / sponsor ID
- CEBD-CU-2018-09-30
- Conditions
- Single Posterior Crowns, Badly Decayed Teeth, Teeth Restored With Large Filling Restorations or Endodontically Treated Teeth, Malformed Teeth, Malposed Teeth (Tilted, Over-erupted, Rotated, Etc.) or Spacing Between Posterior Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 26 Sep 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.
Although the metal-ceramic system is still widely used to fabricate crowns and fixed partial dentures and is considered as the standard treatment in dentistry, aesthetic concerns have stimulated the development of new dental tooth-colored systems as PEEK.
BioHPP PEEK is 20% ceramic reinforced, semicrystalline, thermoplastic and radiolucent polymer for extreme durability especially for frameworks for fixed and removable dental prostheses. It has many advantages as low density, light weight, shock absorber, biocompatible and venerable with composite resin.
The aim of this study is to evaluate the clinical performance of milled BioHPP PEEK-based single crowns and compare them to metal-based single 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 |
|---|---|---|
| Metal ceramic single posterior crowns | Active comparator | Other: Metal ceramic single posterior crownsMetal copings veneered with feldspathic porcelain |
| BioHPP PEEK-based single posterior crowns | Experimental | Other: BioHPP PEEK-based single posterior crownsBioHPP PEEK copings veneered with composite resin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- From 18-50 years old, be able to read and sign the informed consent document.
- Have no active periodontal or pulpal diseases, have teeth with good restorations
- Psychologically and physically able to withstand conventional dental procedures
- Patients with teeth problems indicated for single posterior crowns:
- Able to return for follow-up examinations and evaluation
Key exclusion criteria (7 listed)
- Patient less than 18 or more than 50 years
- Patient with active resistant periodontal diseases
- Patients with poor oral hygiene and uncooperative patients
- Pregnant women
- Patients in the growth stage with partially erupted teeth
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 |
|---|---|---|
| BioHPP PEEK-based single posterior crownsBioHPP PEEK is 20% ceramic reinforced, semicrystalline, thermoplastic and radiolucent polymer for extreme durability especially for frameworks for fixed and removable dental prostheses. It has many advantages as low density, light weight, shock absorber, biocompatible and venerable with composite resin. | Other | BioHPP PEEK-based single posterior crowns |
| Metal ceramic single posterior crownsAlso: Porcelain fused to metal (PFM) or Ceramo-metallicStandard metal coping veneered with glass ceramics | Other | Metal ceramic single posterior crowns |
Primary outcome
Fracture
Time frame: 1 year
Measured using modified USPHS criteria
1 secondary outcome
Marginal adaptation
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 26 Sep 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.
Amina Zaki contact
Questions about this trial
What is this clinical trial studying?
A study testing BioHPP PEEK-based single posterior crowns and Metal ceramic single posterior crowns in people with Single Posterior Crowns and Badly Decayed Teeth, Teeth Restored With Large Filling Restorations or Endodontically Treated Teeth, 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 11 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 26 Sep 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 Abdelrahman Badran, M.D.s (01007029340, asbadran77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture (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 26 Sep 2018.