Carious ToothNCT03701178
One Year Clinical Evaluation of Milled BioHPP (PEEK) Versus Zirconia Veneered Single Crowns (RCT-one-year Evaluation).
A study testing BioHPP PEEK in people with Carious Tooth, run by Cairo University.
Trial summary
All ceramic crowns are indicated in case of mild to moderate discoloration, restoration of traumatized or fractured teeth and abnormal tooth anatomy. Long term success of all ceramic crowns is affected by many factors. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Carious Tooth
- What is being tested?
- BioHPP PEEK
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Nov 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 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 / 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.
Lamia Sayed, Professor contact
About this study
Official title: One Year Clinical Evaluation of Milled BioHPP Polyetheretherketone (PEEK) Versus Zirconia Veneered Single Crowns (Randomized Controlled Clinical Trial-one-year Evaluation).
All ceramic crowns are indicated in case of mild to moderate discoloration, restoration of traumatized or fractured teeth and abnormal tooth anatomy. Long term success of all ceramic crowns is affected by many factors. Fracture of the all ceramic crowns is the most repeated failure pattern and represents about 67% of total failures associated with this type of restoration through a period of 15 years of clinical performance.
Polyetheretherketone (PEEK) is a polymer that has many potentials uses in dentistry. Polyetheretherketone (PEEK) can be used to support fixed dental prostheses. However, information about physio mechanical characterization is still scarce.
Read the detailed description
Polyetheretherketone (PEEK) is a synthetic, tooth colored polymeric material that has been used as a biomaterial in orthopedics for many years due to its lower Young's (elastic) modulus (3-4 GPa) being close to human bone. PEEK can be modified easily by incorporation of other materials. For example; incorporation of carbon fibers or glass fibers can increase the elastic modulus up to 18 GPa which becomes comparable to those of cortical bone and dentin so the polymer could exhibit good stress distribution . Moreover, tensile properties of PEEK are also analogous to those of bone, enamel and dentin making it a suitable restorative material as far as the mechanical properties are concerned.
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.
BioHPP PEEK can be fabricated via CAD/CAM technology by milling PEEK blanks. It is also can be pressed by using granular or pellet-shaped PEEK. Three-unit PEEK fixed partial denture manufactured via CAD-CAM has been suggested to have a higher fracture resistance than pressed granular- or pellet-shaped PEEK dentures.
The fracture resistance of the CAD/CAM milled PEEK fixed dentures is much higher than those of lithium disilicate glass-ceramic (950N), alumina (851N) , zirconia (981-1331N). The abrasive properties of PEEK are excellent. Despite of significantly low elastic moduli and hardness, abrasive resistance of PEEK is competitive with metallic alloys .
BioHPP PEEK can be used under resin composite as a coping material. Because the mechanical properties of PEEK are similar to those of dentin and enamel, PEEK could have an advantage over alloy and ceramic restorations . A variety of procedures have been suggested to condition the surface of PEEK in order to facilitate its bonding with resin composite crowns. For example, air abrasion with and without silica coating creates a more wettable surface. Etching with sulphuric acid creates a rough and chemically altered surface which enables it to bond more effectively with hydrophobic resin composites .
Due to these unique physical and mechanical properties, BioHPP PEEK is a promising material for dental application and it has been proposed for other prosthodontic applications such as fixed prostheses and removable prostheses .
- Conditions
- Carious Tooth
- Being tested
- BioHPP PEEK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioHPP PEEKOther
milled BioHPP PEEK in a new material can be used as a dental restoration
| Study group | Role | What they receive |
|---|---|---|
| zirconia veneered crowns | Active comparator | we will use zirconia veneered single crowns as a control to evaluate the marginal integrity and fracture and patient satisfaction Receives: Other: BioHPP PEEK |
| milled BioHpp PEEK | Experimental | we will use milled BioHPP PEEK single crowns as a intervention to evaluate the marginal integrity and fracture and patient satisfaction Receives: Other: BioHPP PEEK |
What is being measured
The primary outcome is the main question the study is designed to answer.
fracture
number of fracture
Measured: 1 year
Secondary outcomes (1)
marginal interity
marginal gap at the finish line
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 posted9 Oct 2018
- Study startNov 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious ToothStudies 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mustafa hassan, Cairo University
- Investigators
- abdelrahman M el sokkary, mastrer, Study chair, researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701178
- Sponsor's protocol ID
- CEBD-CU-2018-09-38
- Status last verified
- Oct 2018
- First submitted
- 7 Oct 2018
- Last updated
- 11 Oct 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 11 Oct 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) Versus Zirconia Veneered Single Crowns (Randomized Controlled Clinical Trial-one-year Evaluation).
- ClinicalTrials.gov ID
- NCT03701178
- Acronym / sponsor ID
- CEBD-CU-2018-09-38
- Conditions
- Carious Tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 9 Oct 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.
All ceramic crowns are indicated in case of mild to moderate discoloration, restoration of traumatized or fractured teeth and abnormal tooth anatomy. Long term success of all ceramic crowns is affected by many factors. Fracture of the all ceramic crowns is the most repeated failure pattern and represents about 67% of total failures associated with this type of restoration through a period of 15 years of clinical performance.
Polyetheretherketone (PEEK) is a polymer that has many potentials uses in dentistry. Polyetheretherketone (PEEK) can be used to support fixed dental prostheses. However, information about physio mechanical characterization is still scarce.
Detailed description
Polyetheretherketone (PEEK) is a synthetic, tooth colored polymeric material that has been used as a biomaterial in orthopedics for many years due to its lower Young's (elastic) modulus (3-4 GPa) being close to human bone. PEEK can be modified easily by incorporation of other materials. For example; incorporation of carbon fibers or glass fibers can increase the elastic modulus up to 18 GPa which becomes comparable to those of cortical bone and dentin so the polymer could exhibit good stress distribution . Moreover, tensile properties of PEEK are also analogous to those of bone, enamel and dentin making it a suitable restorative material as far as the mechanical properties are concerned.
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.
BioHPP PEEK can be fabricated via CAD/CAM technology by milling PEEK blanks. It is also can be pressed by using granular or pellet-shaped PEEK. Three-unit PEEK fixed partial denture manufactured via CAD-CAM has been suggested to have a higher fracture resistance than pressed granular- or pellet-shaped PEEK dentures.
The fracture resistance of the CAD/CAM milled PEEK fixed dentures is much higher than those of lithium disilicate glass-ceramic (950N), alumina (851N) , zirconia (981-1331N). The abrasive properties of PEEK are excellent. Despite of significantly low elastic moduli and hardness, abrasive resistance of PEEK is competitive with metallic alloys .
BioHPP PEEK can be used under resin composite as a coping material. Because the mechanical properties of PEEK are similar to those of dentin and enamel, PEEK could have an advantage over alloy and ceramic restorations . A variety of procedures have been suggested to condition the surface of PEEK in order to facilitate its bonding with resin composite crowns. For example, air abrasion with and without silica coating creates a more wettable surface. Etching with sulphuric acid creates a rough and chemically altered surface which enables it to bond more effectively with hydrophobic resin composites .
Due to these unique physical and mechanical properties, BioHPP PEEK is a promising material for dental application and it has been proposed for other prosthodontic applications such as fixed prostheses and removable prostheses .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zirconia veneered crowns | Active comparator | Other: BioHPP PEEKwe will use zirconia veneered single crowns as a control to evaluate the marginal integrity and fracture and patient satisfaction |
| milled BioHpp PEEK | Experimental | Other: BioHPP PEEKwe will use milled BioHPP PEEK single crowns as a intervention to evaluate the marginal integrity and fracture and patient satisfaction |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 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: (Badly decayed teeth / Teeth restored with large filling restorations / 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.
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 PEEKmilled BioHPP PEEK in a new material can be used as a dental restoration | Other | milled BioHpp PEEK, zirconia veneered crowns |
Primary outcome
fracture
Time frame: 1 year
number of fracture
1 secondary outcome
marginal interity
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 11 Oct 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.
Lamia Sayed, Professor contact
abdelrahman M el sokkary, mastrer study chair
researcher
Questions about this trial
What is this clinical trial studying?
A study testing BioHPP PEEK in people with Carious Tooth, 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 5 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 11 Oct 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 mustafa, M.D.s (01024884480, dr_lamina_propria@windowslive.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 11 Oct 2018; AzTrials last refreshed its copy on 8 Nov 2026.