Complete EdentulismNCT05443048
Evaluation of Monolithic Milled Complete Removable Dentures
A study testing Ivoclar Ivotion Denture System in people with Complete Edentulism, run by Frauke Müller at 1 site in Switzerland.
Trial summary
The use of complete removable dental prostheses (CRDP) is a reliable and effective treatment option for the rehabilitation of edentulous persons. In recent years, the use of computer-aided design/computer-aided manufacturing (CAD/CAM) methods has become more popular for the fabrication of CRDPs, including subtractive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- Ivoclar Ivotion Denture System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2022to 31 Aug 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Informed Consent as documented by signature
- Healed edentulous maxilla and mandible (minimum one year since last extraction)
Who cannot join
- Contraindications to the medical devices used, e.g. known hypersensitivity or allergy
- Vulnerable subjects
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the investigation
- Participation in another investigation with a MD in the field of dentistry
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Show all 14Show fewer
- Reported severe bruxism or clenching habits, clinically present oro-facial pain
- Width of edentulous maxilla > 80 mm
- Width of edentulous mandible > 80 mm
- Vertical height needed for maxillary prosthesis > 38 mm
- Vertical height needed for mandibular prosthesis > 38 mm
- Depression: Geriatric Depression Scale > 9
- Xerostomia: SSFR ≤ 0.7ml/min
- Dementia: Clock-Drawing Test ≤ 5
Trial locations and contacts
1 site in 1 country.
About this study
The use of complete removable dental prostheses (CRDP) is a reliable and effective treatment option for the rehabilitation of edentulous persons.
In recent years, the use of computer-aided design/computer-aided manufacturing (CAD/CAM) methods has become more popular for the fabrication of CRDPs, including subtractive methods (milling) from a prefabricated resin puck. They present various advantages compared to conventional fabrication methods, namely improved mechanical properties, superior surface characteristics, shortened manufacturing time and lower cost for the patient.
Read more
However, one of the shortcomings in the manufacturing of CRDPs from a single block of resin is obtaining an adequate esthetic outcome, as the transition between the gingiva-colored (pink) and tooth-colored (white) resin is not as precise as with prefabricated prosthetic teeth which are incorporated into a denture base. A novel technology has recently been launched on the market and includes a new design of distribution of pink and white resin inside a prefabricated resin puck, which would allow a superior esthetic outcome than previous techniques.
The aim of this pilot study is to assess the end result of one of the available systems used for fabricating digital dentures (Ivoclar® Digital Denture®), while using the corresponding monolithic resin puck (Ivoclar® Ivotion Denture System®), and therefore determining whether this new technique is an adequate option for treating edentulous patients.
- Conditions
- Complete Edentulism
- Being tested
- Ivoclar Ivotion Denture System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivoclar Ivotion Denture SystemDevice
Fabrication of maxillary and mandibular complete removable dental prosthesis with the Ivoclar Ivotion Denture System
| Study group | Role | What they receive |
|---|---|---|
| Ivoclar Ivotion Denture System | Experimental | Not described Receives: Device: Ivoclar Ivotion Denture System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esthetics
The transition between the pink and white resin will be evaluated by means of a Visual Analogue Scale esthetic score Maximum (best outcome): 1000 Minimum (worst outcome): 0
Measured: Baseline (BL, with existing dentures)
Esthetics
The transition between the pink and white resin will be evaluated by means of a Visual Analogue Scale esthetic score Maximum (best outcome): 1000 Minimum (worst outcome): 0
Measured: Day 0 (T0, new dentures)
Esthetics
The transition between the pink and white resin will be evaluated by means of a Visual Analogue Scale esthetic score Maximum (best outcome): 1000 Minimum (worst outcome): 0
Measured: 3 months (T1)
Secondary outcomes (13)
Oral health-related quality of life
OHIP-EDENT: validated questionnaire with 19 questions related to 7 dimensions, by means of a 6-item Likert scale Maximum (worst outcome): 7 Minimum (best outcome: 0
Measured: Baseline (BL, with existing dentures)
Oral health-related quality of life
OHIP-EDENT: validated questionnaire with 19 questions related to 7 dimensions, by means of a 6-item Likert scale Maximum (worst outcome): 7 Minimum (best outcome: 0
Measured: Day 0 (T0, new dentures)
Oral health-related quality of life
OHIP-EDENT: validated questionnaire with 19 questions related to 7 dimensions, by means of a 6-item Likert scale Maximum (worst outcome): 7 Minimum (best outcome: 0
Measured: 3 months (T1)
Denture satisfaction
Denture Satisfaction Index: validated questionnaire with 24 questions related to 9 dimensions, by means of a Visual Analogue Scale Maximum (best outcome): 900 Minimum (worst outcome): 0
Measured: Baseline (BL, with existing dentures)
Denture satisfaction
Denture Satisfaction Index: validated questionnaire with 24 questions related to 9 dimensions, by means of a Visual Analogue Scale Maximum (best outcome): 900 Minimum (worst outcome): 0
Measured: Day 0 (T0, new dentures)
Denture satisfaction
Denture Satisfaction Index: validated questionnaire with 24 questions related to 9 dimensions, by means of a Visual Analogue Scale Maximum (best outcome): 900 Minimum (worst outcome): 0
Measured: 3 months (T1)
Masticatory analysis
Chewing efficiency will be evaluated with a two-color mixing ability test
Measured: Baseline (BL, with existing dentures)
Masticatory analysis
Chewing efficiency will be evaluated with a two-color mixing ability test
Measured: Day 0 (T0, new dentures)
Masticatory analysis
Chewing efficiency will be evaluated with a two-color mixing ability test
Measured: 3 months (T1)
Prosthetic Evaluation
Denture quality objectively based on the seven criteria adopted from Alfadda et al., 2014, using a scoring sheet with 16 questions, by means of a 3-item Likert scale Maximum (worst score): 48 Minimum (best score): 16
Measured: Day 0 (T0, new dentures)
Prosthetic Evaluation
Denture quality objectively based on the seven criteria adopted from Alfadda et al., 2014, using a scoring sheet with 16 questions, by means of a 3-item Likert scale Maximum (worst score): 48 Minimum (best score): 16
Measured: 3 months (T1)
Number of prosthetic maintenance needed
events such as adjustment and repair requirements will be recorded
Measured: 3 months (T1)
Willingness to Pay
open-ended contingency valuation (CV) method of questioning with the use of a payment card. The score is the amount in Swiss Francs the participant would be willing to pay for the treatment.
Maximum: no maximum Minimum: 0.
Measured: 3 months (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Sep 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete EdentulismStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frauke Müller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Frauke Müller, University of Geneva, Switzerland
- Investigators
- Sabrina Maniewicz, Dr, Principal investigator, Research and Teaching Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443048
- Sponsor's protocol ID
- Ivotion Pilot Study
- Status last verified
- Jun 2022
- First submitted
- 21 Jun 2022
- Last updated
- 17 Dec 2024
- 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 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Monolithic Milled Complete Removable Dentures
- ClinicalTrials.gov ID
- NCT05443048
- Acronym / sponsor ID
- Ivotion Pilot Study
- Conditions
- Complete Edentulism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Frauke MüllerUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 5 Jul 2022 (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.
The use of complete removable dental prostheses (CRDP) is a reliable and effective treatment option for the rehabilitation of edentulous persons.
In recent years, the use of computer-aided design/computer-aided manufacturing (CAD/CAM) methods has become more popular for the fabrication of CRDPs, including subtractive methods (milling) from a prefabricated resin puck. They present various advantages compared to conventional fabrication methods, namely improved mechanical properties, superior surface characteristics, shortened manufacturing time and lower cost for the patient.
However, one of the shortcomings in the manufacturing of CRDPs from a single block of resin is obtaining an adequate esthetic outcome, as the transition between the gingiva-colored (pink) and tooth-colored (white) resin is not as precise as with prefabricated prosthetic teeth which are incorporated into a denture base. A novel technology has recently been launched on the market and includes a new design of distribution of pink and white resin inside a prefabricated resin puck, which would allow a superior esthetic outcome than previous techniques.
The aim of this pilot study is to assess the end result of one of the available systems used for fabricating digital dentures (Ivoclar® Digital Denture®), while using the corresponding monolithic resin puck (Ivoclar® Ivotion Denture System®), and therefore determining whether this new technique is an adequate option for treating edentulous patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ivoclar Ivotion Denture System | Experimental | Device: Ivoclar Ivotion Denture System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Informed Consent as documented by signature
- Healed edentulous maxilla and mandible (minimum one year since last extraction)
Key exclusion criteria (14 listed)
- Contraindications to the medical devices used, e.g. known hypersensitivity or allergy
- Vulnerable subjects
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the investigation
- Participation in another investigation with a MD in the field of dentistry
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 |
|---|---|---|
| Ivoclar Ivotion Denture SystemFabrication of maxillary and mandibular complete removable dental prosthesis with the Ivoclar Ivotion Denture System | Device | Ivoclar Ivotion Denture System |
Primary outcome
Esthetics
Time frame: Baseline (BL, with existing dentures)
The transition between the pink and white resin will be evaluated by means of a Visual Analogue Scale esthetic score Maximum (best outcome): 1000 Minimum (worst outcome): 0
Esthetics
Time frame: Day 0 (T0, new dentures)
The transition between the pink and white resin will be evaluated by means of a Visual Analogue Scale esthetic score Maximum (best outcome): 1000 Minimum (worst outcome): 0
Esthetics
Time frame: 3 months (T1)
The transition between the pink and white resin will be evaluated by means of a Visual Analogue Scale esthetic score Maximum (best outcome): 1000 Minimum (worst outcome): 0
13 secondary outcomes
Oral health-related quality of life
Time frame: Baseline (BL, with existing dentures)
Oral health-related quality of life
Time frame: Day 0 (T0, new dentures)
Oral health-related quality of life
Time frame: 3 months (T1)
Denture satisfaction
Time frame: Baseline (BL, with existing dentures)
Denture satisfaction
Time frame: Day 0 (T0, new dentures)
Denture satisfaction
Time frame: 3 months (T1)
Masticatory analysis
Time frame: Baseline (BL, with existing dentures)
Masticatory analysis
Time frame: Day 0 (T0, new dentures)
Masticatory analysis
Time frame: 3 months (T1)
Prosthetic Evaluation
Time frame: Day 0 (T0, new dentures)
Prosthetic Evaluation
Time frame: 3 months (T1)
Number of prosthetic maintenance needed
Time frame: 3 months (T1)
Willingness to Pay
Time frame: 3 months (T1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- 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.
Sabrina Maniewicz, Dr principal investigator
Research and Teaching Fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ivoclar Ivotion Denture System in people with Complete Edentulism, run by Frauke Müller at 1 site in Switzerland.
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 3 inclusion and 14 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 17 Dec 2024. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Esthetics (time frame: Baseline (BL, with existing dentures)). The study lists 3 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 17 Dec 2024.