Occlusal CariesNCT04532671
Evaluation of Clinical Performance of 3D Printed Polyether Ether Ketone (PEEK) Inlays
A study testing Poly ether ether ketone (PEEK), CADCAM Poly ether ether ketone (PEEK) and indirect resin composite in people with Occlusal Caries, run by Cairo University.
Trial summary
In patients using Inlay restorations will the use of 3D printed PEEK material and technique have superior clinical performance to milled PEEK one or to milled composite resin inlays, evaluation of restorations will be done at baseline, six months and 12 months using the modified US Public Health Service (USPHS)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occlusal Caries
- What is being tested?
- Poly ether ether ketone (PEEK), CADCAM Poly ether ether ketone (PEEK) and indirect resin composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Oct 2022
- 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
- Patients aging greater than or equal 18 years.
- Patients with a high level of oral hygiene.
- Each patient enrolled in the study had moderate to large size carious lesion or defective restoration to be replaced on a maxillary or mandibular permanent molar.
- Patients with good likelihood of recall availability.
Who cannot join
- Participants with general/systemic illness.
- Pregnant or lactating females.
- Concomitant participation in another research study.
- Inability to comply with study procedures.
- Heavy bruxism habits.
- Last experience with allergic reactions against any components of the used materials.
- Patients receiving orthodontic treatment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Clinical Performance of 3D Printed Polyether Ether Ketone (PEEK) Inlays Compared With Milled Indirect PEEK Inlays Versus Indirect Resin Composite Inlays Over One Year Period of Time (A Randomized Clinical Trial)
In patients using Inlay restorations will the use of 3D printed PEEK material and technique have superior clinical performance to milled PEEK one or to milled composite resin inlays, evaluation of restorations will be done at baseline, six months and 12 months using the modified US Public Health Service (USPHS) evaluation system
Read the detailed description
The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University; The operator in charge will be Donia Mamdouh Elshafey Patients will be selected from the outpatient clinic of the department Conservative Dentistry Department, Faculty of Dentistry, Cairo University All cavity preparations will be performed with fine inlay burs according to inlay cavity principles. The walls facing each other will be prepared 5 to 6 degree divergent with 80 μm diamond burs and were finished with 25 μm diamond burs. All internal angles will be rounded and all edges will terminate in the enamel. The pulpal floor will be prepared at a depth of at least 1.5 mm. The teeth will be discarded if isthmus width was more than 2/3 of the distance between the tubercule tips, or if the walls are thinner than 2 mm before the preparation or thinner than 1.5 mm after the preparation. The caries affected dentin tissue at the cavity floor will be left. The teeth will be discarded from study if the pulp is exposed. To eliminate irregular areas in the cavities, a liner will be applied as a blockout material. Then the operator will adhere strictly to the manufacturer's instructions in the imaging, computer design and machining of the restorations either 3D printing or milling procedure.
The prepared teeth for the indirect restorations will be scanned with an optical 3D camera (CEREC Omnicam, Dentsply Sirona, Bensheim, Germany), inlays will be designed by a CAD software (CEREC SW 4.6.1, Dentsply Sirona), and files will be created in STL format (inLab CAD SW 18.1, Dentsply Sirona) then inlays will additively manufactured After the printing process is finished, the inlays will be immediately removed from the building platform and cooled down at room temperature. The inlay will be adapted individually to its cavity, and the occlusal surface will be recontoured. Such post processing also will be performed on the milled inlays. After all inlays are adequately adapted, they will be adhesively inserted into the cavities.
- Conditions
- Occlusal Caries
- Being tested
- Poly ether ether ketone (PEEK), CADCAM Poly ether ether ketone (PEEK), indirect resin composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly ether ether ketone (PEEK)Other
PEEK has been used in dentistry so far in certain fields as for, removable and fixed dental prostheses, implants, and implant abutments as well as orthodontic devices, whereas in literature, it is mostly mentioned in relation to prosthetics. PEEK was predominantly processed out of CAD/CAM-supported milled out of prefabricated blanks. Producing dental restorations via Additive manufacturing is still hardly widespread
CADCAM Poly ether ether ketone (PEEK)Other
Increased demand for long-lasting restoration's properties have led to many improvements in the production techniques of posterior restorations such as CAD/CAM systems. This technique simplifies the production of indirect restorations and make it possible to use advanced materials as PEEK
indirect resin compositeOther
CADCAM resin composite blocks using milling process
| Study group | Role | What they receive |
|---|---|---|
| Poly ether ether ketone (PEEK) | Other | Poly ether ether keton (PEEK) is acknowledged as a high-performance polymer in engineering \& medical applications due to its favorable mechanical and chemical properties. Receives: Other: Poly ether ether ketone (PEEK) |
| CADCAM poly ether ether ketone (PEEK) | Other | PEEK was predominantly processed out of CAD/CAM-supported milled out of prefabricated blanks. Receives: Other: CADCAM Poly ether ether ketone (PEEK) |
| indirect resin composite | Active comparator | In CAD/CAM resin composite blocks, properties of flexibility and ease of use similar to that of resin composite are combined with durability and surface finish properties similar to that of ceramics Receives: Other: indirect resin composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal integrity
Visual inspection with explorer and mirror, Distance penetrated by the Explorer at the tooth restoration interface
Measured: 12 months
marginal discoloration
Visual inspection with a mirror at 18 inches, the degree of mismatch from the normal range of tooth shades and translucency Visual inspection to check the proximity of the shade from the natural tooth
Measured: 12 months
secondary caries
Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
Measured: 12 months
post operative sensitivity
Asking the patient if there is any associated pain after adding the restoration
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occlusal CariesStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, donia elshafey, Cairo University
- Investigators
- Donia M elshafey, master, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532671
- Sponsor's protocol ID
- 88245
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Performance of 3D Printed Polyether Ether Ketone (PEEK) Inlays Compared With Milled Indirect PEEK Inlays Versus Indirect Resin Composite Inlays Over One Year Period of Time (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04532671
- Acronym / sponsor ID
- 88245
- Conditions
- Occlusal Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 31 Aug 2020 (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.
In patients using Inlay restorations will the use of 3D printed PEEK material and technique have superior clinical performance to milled PEEK one or to milled composite resin inlays, evaluation of restorations will be done at baseline, six months and 12 months using the modified US Public Health Service (USPHS) evaluation system
Detailed description
The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University; The operator in charge will be Donia Mamdouh Elshafey Patients will be selected from the outpatient clinic of the department Conservative Dentistry Department, Faculty of Dentistry, Cairo University All cavity preparations will be performed with fine inlay burs according to inlay cavity principles. The walls facing each other will be prepared 5 to 6 degree divergent with 80 μm diamond burs and were finished with 25 μm diamond burs. All internal angles will be rounded and all edges will terminate in the enamel. The pulpal floor will be prepared at a depth of at least 1.5 mm. The teeth will be discarded if isthmus width was more than 2/3 of the distance between the tubercule tips, or if the walls are thinner than 2 mm before the preparation or thinner than 1.5 mm after the preparation. The caries affected dentin tissue at the cavity floor will be left. The teeth will be discarded from study if the pulp is exposed. To eliminate irregular areas in the cavities, a liner will be applied as a blockout material. Then the operator will adhere strictly to the manufacturer's instructions in the imaging, computer design and machining of the restorations either 3D printing or milling procedure.
The prepared teeth for the indirect restorations will be scanned with an optical 3D camera (CEREC Omnicam, Dentsply Sirona, Bensheim, Germany), inlays will be designed by a CAD software (CEREC SW 4.6.1, Dentsply Sirona), and files will be created in STL format (inLab CAD SW 18.1, Dentsply Sirona) then inlays will additively manufactured After the printing process is finished, the inlays will be immediately removed from the building platform and cooled down at room temperature. The inlay will be adapted individually to its cavity, and the occlusal surface will be recontoured. Such post processing also will be performed on the milled inlays. After all inlays are adequately adapted, they will be adhesively inserted into the cavities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Poly ether ether ketone (PEEK) | Other | Other: Poly ether ether ketone (PEEK)Poly ether ether keton (PEEK) is acknowledged as a high-performance polymer in engineering \& medical applications due to its favorable mechanical and chemical properties. |
| CADCAM poly ether ether ketone (PEEK) | Other | Other: CADCAM Poly ether ether ketone (PEEK)PEEK was predominantly processed out of CAD/CAM-supported milled out of prefabricated blanks. |
| indirect resin composite | Active comparator | Other: indirect resin compositeIn CAD/CAM resin composite blocks, properties of flexibility and ease of use similar to that of resin composite are combined with durability and surface finish properties similar to that of ceramics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aging greater than or equal 18 years.
- Patients with a high level of oral hygiene.
- Each patient enrolled in the study had moderate to large size carious lesion or defective restoration to be replaced on a maxillary or mandibular permanent molar.
- Patients with good likelihood of recall availability.
Key exclusion criteria (7 listed)
- Participants with general/systemic illness.
- Pregnant or lactating females.
- Concomitant participation in another research study.
- Inability to comply with study procedures.
- Heavy bruxism habits.
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 ether ketone (PEEK)PEEK has been used in dentistry so far in certain fields as for, removable and fixed dental prostheses, implants, and implant abutments as well as orthodontic devices, whereas in literature, it is mostly mentioned in relation to prosthetics. PEEK was predominantly processed out of CAD/CAM-supported milled out of prefabricated blanks. Producing dental restorations via Additive manufacturing is still hardly widespread | Other | Poly ether ether ketone (PEEK) |
| CADCAM Poly ether ether ketone (PEEK)Increased demand for long-lasting restoration's properties have led to many improvements in the production techniques of posterior restorations such as CAD/CAM systems. This technique simplifies the production of indirect restorations and make it possible to use advanced materials as PEEK | Other | CADCAM poly ether ether ketone (PEEK) |
| indirect resin compositeCADCAM resin composite blocks using milling process | Other | indirect resin composite |
Primary outcome
Marginal integrity
Time frame: 12 months
Visual inspection with explorer and mirror, Distance penetrated by the Explorer at the tooth restoration interface
marginal discoloration
Time frame: 12 months
Visual inspection with a mirror at 18 inches, the degree of mismatch from the normal range of tooth shades and translucency Visual inspection to check the proximity of the shade from the natural tooth
secondary caries
Time frame: 12 months
Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
post operative sensitivity
Time frame: 12 months
Asking the patient if there is any associated pain after adding the restoration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Individual participant dataSharing planned: Yes. Undecided: It is not yet known if there will be a plan to make IPD available.
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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.
Donia M elshafey, master principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Poly ether ether ketone (PEEK), CADCAM Poly ether ether ketone (PEEK) and indirect resin composite in people with Occlusal Caries, 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 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 31 Aug 2020. 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 donia M elshafey, master (1008820027 ext. +20, donia.mamdouh@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal integrity (time frame: 12 months). The study lists 4 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 31 Aug 2020.