Edentulous MouthNCT05599269
Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth
A study testing Examination of dentures with SR Phonares II teeth in people with Edentulous Mouth and Dental Prosthesis Failure, run by Ivoclar Vivadent AG at 1 site in Liechtenstein.
Trial summary
This retrospective study investigates the longevity of dentures with SR Phonares II teeth after a wearing period of more than 10 years. The primary objective is to assess the survival rate of dentures with SR Phonares II teeth after more than 10 years. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Mouth, Dental Prosthesis Failure
- What is being tested?
- Examination of dentures with SR Phonares II teeth
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteLiechtenstein
- Study dates
- 18 Nov 2022to 11 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- informed consent signed and understood by the subject
- partial or full denture with SR Phonares II teeth
- dentures delivered in the internal clinic between August 2010 and August 2012
- to be able to visit the internal clinic (Exception: Patients with limited mobility are also included if another person can carry the dentures to the internal clinic of Ivoclar Vivadent AG for the examination.)
Who cannot join
- patient does not wear the dentures regularly
- health status (physical and mental) does not allow participation.
Trial locations and contacts
1 site in 1 country.
Liechtenstein1 site
Ivoclar Vivadent AG
Schaan, 9494
About this study
Official title: Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth SR Phonares II
This retrospective study investigates the longevity of dentures with SR Phonares II teeth after a wearing period of more than 10 years.
The primary objective is to assess the survival rate of dentures with SR Phonares II teeth after more than 10 years. The secondary objectives asses the quality of the dentures concerning aesthetic, functional and biological properties.
- Conditions
- Edentulous Mouth, Dental Prosthesis Failure
- Being tested
- Examination of dentures with SR Phonares II teeth
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examination of dentures with SR Phonares II teethDevice
The intraoral situation will be examined similar to a standard dental examination. The dentures are then removed, cleaned and examined extraoral. Pictures and an impression of the dentures are taken.
| Study group | Role | What they receive |
|---|---|---|
| Examination of dentures with SR Phonares II teeth | Other | Not described Receives: Device: Examination of dentures with SR Phonares II teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rate of Dentures With SR Phonares II Teeth
After a wearing time of 10 years dentures with SR Phonares II teeth were examined by a dentist
Measured: 10 years
Secondary outcomes (1)
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
After a wearing time of 10 years dentures with SR Phonares II teeth were evaluated by a dentist according to adopted FDI criteria.
Aesthetic properties (surface luster, surface staining, plaque accumulation, color match (to a reference), functional properties (fracture of material, marginal adaption, occlusal contour and wear, patient's view (evaluated during discussion) and biological properties (adjacent mucosa, oral health) were eveluated according the following FDI grades:
- FDI grade 1: clinically excellent
- FDI grade 2: clinically good
- FDI grade 3: clinically satisfactory
- FDI grade 4: clinically unsatisfactory
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start18 Nov 2022
- Primary completion11 Apr 2023
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Model description
- retrospective study
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivoclar Vivadent AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599269
- Sponsor's protocol ID
- LL5267725
- Status last verified
- Sep 2025
- First submitted
- 20 Oct 2022
- Last updated
- 8 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth SR Phonares II
- ClinicalTrials.gov ID
- NCT05599269
- Acronym / sponsor ID
- LL5267725
- Conditions
- Edentulous Mouth, Dental Prosthesis Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Ivoclar Vivadent AGIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 31 Oct 2022 (actual)
- Results
- Posted 28 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective study investigates the longevity of dentures with SR Phonares II teeth after a wearing period of more than 10 years.
The primary objective is to assess the survival rate of dentures with SR Phonares II teeth after more than 10 years. The secondary objectives asses the quality of the dentures concerning aesthetic, functional and biological properties.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- retrospective study
| Arm | Type | Receives |
|---|---|---|
| Examination of dentures with SR Phonares II teeth | Other | Device: Examination of dentures with SR Phonares II teeth |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- informed consent signed and understood by the subject
- partial or full denture with SR Phonares II teeth
- dentures delivered in the internal clinic between August 2010 and August 2012
- to be able to visit the internal clinic (Exception: Patients with limited mobility are also included if another person can carry the dentures to the internal clinic of Ivoclar Vivadent AG for the examination.)
Key exclusion criteria (2 listed)
- patient does not wear the dentures regularly
- health status (physical and mental) does not allow participation.
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 |
|---|---|---|
| Examination of dentures with SR Phonares II teethThe intraoral situation will be examined similar to a standard dental examination. The dentures are then removed, cleaned and examined extraoral. Pictures and an impression of the dentures are taken. | Device | Examination of dentures with SR Phonares II teeth |
Primary outcome
Survival Rate of Dentures With SR Phonares II Teeth
Time frame: 10 years
After a wearing time of 10 years dentures with SR Phonares II teeth were examined by a dentist
1 secondary outcome
Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
Time frame: 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Examination of dentures with SR Phonares II teeth in people with Edentulous Mouth and Dental Prosthesis Failure, 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 8 Oct 2025. 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?
Yes. Results are posted in the registry (first posted 28 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Survival Rate of Dentures With SR Phonares II Teeth (time frame: 10 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 8 Oct 2025.