Clinical PerformanceNCT06092697
Evaluation of 3D Printed Polyether Ether Ketone (PEEK) and Milled PEEK Indirect Restorations Compared to Hybird Resin Composite Indirect Restorations Over One Year Period of Time ( A Randomized Clinical Trial )
A study testing 3D printed PEEK restorations in people with Clinical Performance, run by Cairo University.
Trial summary
Clinical performance evaluation of 3D Printed Polyether ether ketone (PEEK) and milled PEEK indirect restorations compared to hybird resin composite indirect restorations over one year period of time Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Performance
- What is being tested?
- 3D printed PEEK restorations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Apr 2025
- 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
- Patients aging (18-45) years.
- Patients with a high level of oral hygiene.
- Each patient enrolled in the study should have moderate carious lesion or defective restoration needs to be replaced on a mandibular permanent molar.
- Patients with ability to attend periodical follow-ups.
Who cannot join
- Patients with general/systemic diseases or allergies.
- Patients with chronic use of anti- inflammatory, analgesic, and psychotropic drugs.
- Pregnant or lactating females.
- Patients with parafunctional habits.
- Patients with experience of allergic reactions against any components of the used materials.
- Patients receiving orthodontic treatment.
- Inability to comply with study procedures.
- Collateral participation in another research study.
About this study
Clinical performance evaluation of 3D Printed Polyether ether ketone (PEEK) and milled PEEK indirect restorations compared to hybird resin composite indirect restorations over one year period of time
Read the detailed description
The aim of this study is to evaluate fracture and retention, wear of 3D printed PEEK indirect restorations and milled PEEK indirect restorations compared to milled indirect hybrid resin composite restorations according to FDI criteria over one year.
According to indirect restorations cavity preparation principles, shade selection and occlusal examination will be done preoperatively, followed by cavity preparations that will be carried out with tapered diamond stones.
The prepared teeth for the indirect restorations will be scanned with an optical scanner. Then restorations will be designed by a CAD software and files will be made in STL format, so as to be ready for either 3D printing or milling with different materials.
While the printed PEEK restorations are additively made, the milled PEEK and hybrid composite restorations are both milled out of either a disc or block ( size 12) using a CAD/CAM milling machine.
After the printing and the milling procedures are complete, the restorations are then promptly removed. Each restoration will be assessed and adjusted for its cavity after the occlusal surface is recontoured. This post-processing adjustments will be applied to both 3d printed ones and milled restorations. After assessment and needed adjustments are done, all restorations will be cemented into the cavities in accordance with the manufacturer's recommendations.
For each recall examination, two independent evaluators will perform the direct clinical evaluation for the fracture and retention at baseline, after 6 and 12 months using written criteria based on FDI world dental federation criteria. Together with the wear testing that will be performed by scanning of the restoration surfaces at baseline, after 6 and 12 months. Using parallel confocal technology, a 3D dental scanner (CEREC Primescan; Sirona, Bensheim, Germany) to attain the 3D Standard Tessellation Language (STL) models will be used. These scan models will be then introduced through a wear measuring software (Geomagic Design X; 3D Systems, Seoul, Korea) which will import, analyze, and superimpose the digitalized 3D models. So, it will automatically calculate the amount of occlusal volume lose due to wear.
- Conditions
- Clinical Performance
- Being tested
- 3D printed PEEK restorations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed PEEK restorationsOther
Also called Milled PEEK
Indirect dental restoration
| Study group | Role | What they receive |
|---|---|---|
| 3D printed PEEK | Experimental | Indirect dental restoration Receives: Other: 3D printed PEEK restorations |
| Milled PEEK | Experimental | Indirect dental restoration Receives: Other: 3D printed PEEK restorations |
| Hybird resin composite | Active comparator | Indirect dental restoration Receives: Other: 3D printed PEEK restorations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture and retention (Category F1)(Revised FDI criteria for evaluating direct and indirect dental restorations- recommendations for its clinical use, interpretation, and reporting)
Outcome:Fracture of the material and retention Measuring device: Revised FDI criteria for evaluating direct and indirect dental restorations- recommendations for its clinical use, interpretation, and reporting.
(Hickel et al., 2023) Measuring unit: Scoring system (Ordinal) 1. Clinically excellent/very good (sufficient) 2. Clinically good (sufficient) 3. Clinically satisfactory (sufficient) 4. Clinically unsatisfactory (partially insufficient) 5. Clinically poor (entirely insufficient)
Measured: Baseline, 6 months, 12 months
Secondary outcomes (1)
occlusion and wear (Category F5)
Wear potential of the restoration Measuring device: A. Digital scanner (CEREC Primescan intraoral Scanner) B. Geometrical Subtraction software (Geomagic control software) (Tang et al. 2021) Measuring unit : Microns (Quantitative)
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical PerformanceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A superiority frame randomized, controlled, parallel clinical trial with 1:1 allocation ratio.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Ahmed Abdalnaby Ahmed Attia, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092697
- Sponsor's protocol ID
- Hadeer'sPROTOCOL-PHD
- Status last verified
- Oct 2023
- First submitted
- 6 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abhay SS, Ganapathy D, Veeraiyan DN, Ariga P, Heboyan A, Amornvit P, Rokaya D, Srimaneepong V. Wear Resistance, Color Stability and Displacement Resistance of Milled PEEK Crowns Compared to Zirconia Crowns under Stimulated Chewing and High-Performance Aging. Polymers (Basel). 2021 Oct 30;13(21):3761. doi: 10.3390/polym13213761.
PubMed 34771318
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 3D Printed Polyether Ether Ketone (PEEK) and Milled PEEK Indirect Restorations Compared to Hybird Resin Composite Indirect Restorations Over One Year Period of Time ( A Randomized Clinical Trial )
- ClinicalTrials.gov ID
- NCT06092697
- Acronym / sponsor ID
- Hadeer'sPROTOCOL-PHD
- Conditions
- Clinical Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 23 Oct 2023 (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.
Clinical performance evaluation of 3D Printed Polyether ether ketone (PEEK) and milled PEEK indirect restorations compared to hybird resin composite indirect restorations over one year period of time
Detailed description
The aim of this study is to evaluate fracture and retention, wear of 3D printed PEEK indirect restorations and milled PEEK indirect restorations compared to milled indirect hybrid resin composite restorations according to FDI criteria over one year.
According to indirect restorations cavity preparation principles, shade selection and occlusal examination will be done preoperatively, followed by cavity preparations that will be carried out with tapered diamond stones.
The prepared teeth for the indirect restorations will be scanned with an optical scanner. Then restorations will be designed by a CAD software and files will be made in STL format, so as to be ready for either 3D printing or milling with different materials.
While the printed PEEK restorations are additively made, the milled PEEK and hybrid composite restorations are both milled out of either a disc or block ( size 12) using a CAD/CAM milling machine.
After the printing and the milling procedures are complete, the restorations are then promptly removed. Each restoration will be assessed and adjusted for its cavity after the occlusal surface is recontoured. This post-processing adjustments will be applied to both 3d printed ones and milled restorations. After assessment and needed adjustments are done, all restorations will be cemented into the cavities in accordance with the manufacturer's recommendations.
For each recall examination, two independent evaluators will perform the direct clinical evaluation for the fracture and retention at baseline, after 6 and 12 months using written criteria based on FDI world dental federation criteria. Together with the wear testing that will be performed by scanning of the restoration surfaces at baseline, after 6 and 12 months. Using parallel confocal technology, a 3D dental scanner (CEREC Primescan; Sirona, Bensheim, Germany) to attain the 3D Standard Tessellation Language (STL) models will be used. These scan models will be then introduced through a wear measuring software (Geomagic Design X; 3D Systems, Seoul, Korea) which will import, analyze, and superimpose the digitalized 3D models. So, it will automatically calculate the amount of occlusal volume lose due to wear.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A superiority frame randomized, controlled, parallel clinical trial with 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| 3D printed PEEK | Experimental | Other: 3D printed PEEK restorationsIndirect dental restoration |
| Milled PEEK | Experimental | Other: 3D printed PEEK restorationsIndirect dental restoration |
| Hybird resin composite | Active comparator | Other: 3D printed PEEK restorationsIndirect dental restoration |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aging (18-45) years.
- Patients with a high level of oral hygiene.
- Each patient enrolled in the study should have moderate carious lesion or defective restoration needs to be replaced on a mandibular permanent molar.
- Patients with ability to attend periodical follow-ups.
Key exclusion criteria (8 listed)
- Patients with general/systemic diseases or allergies.
- Patients with chronic use of anti- inflammatory, analgesic, and psychotropic drugs.
- Pregnant or lactating females.
- Patients with parafunctional habits.
- Patients with experience of allergic reactions against any components of the used materials.
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 |
|---|---|---|
| 3D printed PEEK restorationsAlso: Milled PEEKIndirect dental restoration | Other | 3D printed PEEK, Hybird resin composite, Milled PEEK |
Primary outcome
Fracture and retention (Category F1)(Revised FDI criteria for evaluating direct and indirect dental restorations- recommendations for its clinical use, interpretation, and reporting)
Time frame: Baseline, 6 months, 12 months
Outcome:Fracture of the material and retention Measuring device: Revised FDI criteria for evaluating direct and indirect dental restorations- recommendations for its clinical use, interpretation, and reporting. (Hickel et al., 2023) Measuring unit: Scoring system (Ordinal) 1. Clinically excellent/very good (sufficient) 2. Clinically good (sufficient) 3. Clinically satisfactory (sufficient) 4. Clinically unsatisfactory (partially insufficient) 5. Clinically poor (entirely insufficient)
1 secondary outcome
occlusion and wear (Category F5)
Time frame: Baseline, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Background: PubMed 34771318Abhay SS, Ganapathy D, Veeraiyan DN, Ariga P, Heboyan A, Amornvit P, Rokaya D, Srimaneepong V. Wear Resistance, Color Stability and Displacement Resistance of Milled PEEK Crowns Compared to Zirconia Crowns under Stimulated Chewing and High-Performance Aging. Polymers (Basel). 2021 Oct 30;13(21):3761. doi: 10.3390/polym13213761.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed PEEK restorations in people with Clinical Performance, 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 4 inclusion and 8 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 23 Oct 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture and retention (Category F1)(Revised FDI criteria for evaluating direct and indirect dental restorations- recommendations for its clinical use, interpretation, and reporting) (time frame: Baseline, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06092697, which also lists 1 linked publication.
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 23 Oct 2023.