Three-Dimensional Printing, Computer-Aided Design, DentalNCT05168852
Permanent Resin Restorations Fabricated by Three Dimension Printer
A study testing Formlabs Permanent CB Resin in people with Three-Dimensional Printing, Computer-Aided Design, Dental, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Additive manufacturing (AM) and 3D printing (3DP) technologies have advanced significantly in many different areas. With the time and cost advantage it provides in low-volume production, 3D printing technologies also come to the fore in the field of digital dentistry. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Three-Dimensional Printing, Computer-Aided Design, Dental
- What is being tested?
- Formlabs Permanent CB Resin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 30 Sep 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- premolar and/or molar tooth has class II caries lesion at D1 or D2 level according to ICDAS caries classification system.
Who cannot join
- bad oral hygiene
- bruxism,
- malocclusion,
- dry mouth,
- periodontal disease,
- teeth with restoration,
- periodontal or periapical pathology non-opposite and/or non-contact teeth will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Cukurova University, Faculty of Dentistry, Department of Restorative Dentistry
Adana, Sarıcam, 01120
zeliha G bek kurklu, PhD, 05334500892, goncabek@mynet.com
About this study
Official title: Evaluation of Clinical Performance of Permanent Resin Restorations Fabricated by 3D Printer
Additive manufacturing (AM) and 3D printing (3DP) technologies have advanced significantly in many different areas. With the time and cost advantage it provides in low-volume production, 3D printing technologies also come to the fore in the field of digital dentistry. A tooth-coloured, ceramic-filled permanent resin has been introduced by the manufacturer for the 3D fabrication of permanent single crowns, veneers, inlays and onlays. The aim of this clinical study was to clinically evaluate the long-term survival and intraoral performance of 3D-printed permanent resin. to the ICDAS caries classification system, 20 volunteers between the ages of 18-65 with class II caries lesion at D1 or D2 level were included in this study. Restorations were checked 1 week (baseline) and 6 months after completion and scored using the Modified Ryge Criteria (USPHS2(United States Public Health Service)). Statistical analysis was done by Kaplan-Meier survival analysis.
Read the detailed description
The design and manufacture of 3D printed restorations relies on the exchange of digital information (data) between 3D imaging, 3D virtual planning and/or 3D printing technologies. One of the key points in the widespread use of 3D printers is the emergence of these systems that allow data from different sources to be used in a personal computer with various design and production technologies. It saves Digital Imaging and Communication in Medicine (DICOM) files in STL format. STL files can be printed and processed with various CAD/CAM systems in local manufacturing or remote labs. This is an important advantage of using open source. With these systems, it is possible to produce restorations with clearer anatomical features thanks to current 3D printing technologies. In other words, low-cost restorations with more useful properties can be produced.
- Being tested
- Formlabs Permanent CB Resin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formlabs Permanent CB ResinOther
Tooth-colored, ceramic-filled permanent resin that can be fabricated with a 3D printer
| Study group | Role | What they receive |
|---|---|---|
| Permanent Resin 1 week | Experimental | 1st week control Receives: Other: Formlabs Permanent CB Resin |
| Permanent Resin 6 mouth | Experimental | 6th month control Receives: Other: Formlabs Permanent CB Resin |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 week follow up
Restorations will be scored 1 week after it is cemented onto the tooth using the Modified Ryge Criteria (USPHS2(United States Public Health Services))
Measured: 1 week
Secondary outcomes (1)
6 mouths follow up
Restorations will be scored 6 mouths after it is cemented onto the tooth using the Modified Ryge Criteria (USPHS2(United States Public Health Services))
Measured: 6 mouths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start1 Dec 2021
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Three-Dimensional Printing, Computer-Aided Design, DentalStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Model description
- After the restorations are applied, the patients are checked in the 1st week and 6th months.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zeliha gonca bek kurklu, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168852
- Sponsor's protocol ID
- cu scientific research unit
- Status last verified
- Dec 2021
- First submitted
- 9 Dec 2021
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Performance of Permanent Resin Restorations Fabricated by 3D Printer
- ClinicalTrials.gov ID
- NCT05168852
- Acronym / sponsor ID
- cu scientific research unit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 23 Dec 2021 (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.
Additive manufacturing (AM) and 3D printing (3DP) technologies have advanced significantly in many different areas. With the time and cost advantage it provides in low-volume production, 3D printing technologies also come to the fore in the field of digital dentistry. A tooth-coloured, ceramic-filled permanent resin has been introduced by the manufacturer for the 3D fabrication of permanent single crowns, veneers, inlays and onlays. The aim of this clinical study was to clinically evaluate the long-term survival and intraoral performance of 3D-printed permanent resin. to the ICDAS caries classification system, 20 volunteers between the ages of 18-65 with class II caries lesion at D1 or D2 level were included in this study. Restorations were checked 1 week (baseline) and 6 months after completion and scored using the Modified Ryge Criteria (USPHS2(United States Public Health Service)). Statistical analysis was done by Kaplan-Meier survival analysis.
Detailed description
The design and manufacture of 3D printed restorations relies on the exchange of digital information (data) between 3D imaging, 3D virtual planning and/or 3D printing technologies. One of the key points in the widespread use of 3D printers is the emergence of these systems that allow data from different sources to be used in a personal computer with various design and production technologies. It saves Digital Imaging and Communication in Medicine (DICOM) files in STL format. STL files can be printed and processed with various CAD/CAM systems in local manufacturing or remote labs. This is an important advantage of using open source. With these systems, it is possible to produce restorations with clearer anatomical features thanks to current 3D printing technologies. In other words, low-cost restorations with more useful properties can be produced.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- After the restorations are applied, the patients are checked in the 1st week and 6th months.
| Arm | Type | Receives |
|---|---|---|
| Permanent Resin 1 week | Experimental | Other: Formlabs Permanent CB Resin1st week control |
| Permanent Resin 6 mouth | Experimental | Other: Formlabs Permanent CB Resin6th month control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- premolar and/or molar tooth has class II caries lesion at D1 or D2 level according to ICDAS caries classification system.
Key exclusion criteria (7 listed)
- bad oral hygiene
- bruxism,
- malocclusion,
- dry mouth,
- periodontal disease,
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 |
|---|---|---|
| Formlabs Permanent CB ResinTooth-colored, ceramic-filled permanent resin that can be fabricated with a 3D printer | Other | Permanent Resin 1 week, Permanent Resin 6 mouth |
Primary outcome
1 week follow up
Time frame: 1 week
Restorations will be scored 1 week after it is cemented onto the tooth using the Modified Ryge Criteria (USPHS2(United States Public Health Services))
1 secondary outcome
6 mouths follow up
Time frame: 6 mouths
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
- Individual participant dataSharing planned: No
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.
Cukurova University, Faculty of Dentistry, Department of Restorative Dentistry
Adana, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formlabs Permanent CB Resin in people with Three-Dimensional Printing, Computer-Aided Design, Dental, run by Cukurova University at 1 site in Turkey (Türkiye).
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 1 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 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 week follow up (time frame: 1 week). 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 23 Dec 2021.