Edentulous MouthNCT06458738
Clinical Evaluation of a New Printable Denture Base Material
A study testing Printable denture base material in people with Edentulous Mouth, run by Ivoclar Vivadent AG at 1 site in Liechtenstein.
Trial summary
This clinical investigation is conducted to prove the long-term clinical performance of a new printable denture base material. The aim of this study is to assess the failure rate, the quality and functionality of the full dentures made with the printable denture base material over an investigational period of 5 years. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Edentulous Mouth
- What is being tested?
- Printable denture base material
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteLiechtenstein
- Study dates
- 29 Jul 2024to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 84 years
- informed consent signed and understood by the subject
- full edentulous patients
- a digital design of the dentures is already existing.
- ability to visit the clinic in person until the baseline recall
Who cannot join
- patient does not wear the dentures regularly
- mental health status does not allow reliable feedback
- patients with a proven allergy to one of the ingredients (methacrylates) of the materials used
- patients with severe systemic diseases
- poor oral / denture hygiene
- pregnancy
Trial locations and contacts
1 site in 1 country.
Liechtenstein1 site
Ivoclar Vivadent AG
Schaan, 9494
About this study
Official title: Clinical Evaluation of a New Printable Denture Base Material: A Prospective Single-arm Study
This clinical investigation is conducted to prove the long-term clinical performance of a new printable denture base material. The aim of this study is to assess the failure rate, the quality and functionality of the full dentures made with the printable denture base material over an investigational period of 5 years.
- Conditions
- Edentulous Mouth
- Being tested
- Printable denture base material
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Printable denture base materialDevice
The newly developed printable denture base material will be used for the production of dentures.
| Study group | Role | What they receive |
|---|---|---|
| Printable denture base material | Experimental | Not described Receives: Device: Printable denture base material |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of failures leading to replacement of denture
number of dentures
Measured: 5 years
Secondary outcomes (3)
functional (e.g. retention) properties of the dentures
Evaluated according to adapted FDI criteria (grade 1-4). Lower scores mean a better outcome.
Measured: 5 years
biological (e.g. plaque accumulation) properties of the dentures
Evaluated according to adapted FDI criteria (grade 1-4). Lower scores mean a better outcome.
Measured: 5 years
aesthetic (e.g. surface staining) properties of the dentures
Evaluated according to adapted FDI criteria (grade 1-4). Lower scores mean a better outcome.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start29 Jul 2024
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous MouthStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ivoclar Vivadent AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458738
- Sponsor's protocol ID
- OTCS 11891315
- Status last verified
- Nov 2026
- First submitted
- 6 Jun 2024
- Last updated
- 4 Nov 2026
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a New Printable Denture Base Material: A Prospective Single-arm Study
- ClinicalTrials.gov ID
- NCT06458738
- Acronym / sponsor ID
- OTCS 11891315
- Conditions
- Edentulous Mouth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Ivoclar Vivadent AGIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 14 Jun 2024 (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.
This clinical investigation is conducted to prove the long-term clinical performance of a new printable denture base material. The aim of this study is to assess the failure rate, the quality and functionality of the full dentures made with the printable denture base material over an investigational period of 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Printable denture base material | Experimental | Device: Printable denture base material |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18 to 84 years
- informed consent signed and understood by the subject
- full edentulous patients
- a digital design of the dentures is already existing.
- ability to visit the clinic in person until the baseline recall
Key exclusion criteria (6 listed)
- patient does not wear the dentures regularly
- mental health status does not allow reliable feedback
- patients with a proven allergy to one of the ingredients (methacrylates) of the materials used
- patients with severe systemic diseases
- poor oral / denture hygiene
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 |
|---|---|---|
| Printable denture base materialThe newly developed printable denture base material will be used for the production of dentures. | Device | Printable denture base material |
Primary outcome
rate of failures leading to replacement of denture
Time frame: 5 years
number of dentures
3 secondary outcomes
functional (e.g. retention) properties of the dentures
Time frame: 5 years
biological (e.g. plaque accumulation) properties of the dentures
Time frame: 5 years
aesthetic (e.g. surface staining) properties of the dentures
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Printable denture base material in people with Edentulous Mouth, run by Ivoclar Vivadent AG at 1 site in Liechtenstein.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. 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 Liechtenstein. 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?
This study is still under way. Results are not available in the source record yet.
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?
rate of failures leading to replacement of denture (time frame: 5 years). 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 4 Nov 2026.