Evaluation of Monolithic Milled Complete Removable Dentures
NCT ID: NCT05443048
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2022-09-01
2023-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ivoclar Ivotion Denture System
Ivoclar Ivotion Denture System
Fabrication of maxillary and mandibular complete removable dental prosthesis with the Ivoclar Ivotion Denture System
Interventions
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Ivoclar Ivotion Denture System
Fabrication of maxillary and mandibular complete removable dental prosthesis with the Ivoclar Ivotion Denture System
Eligibility Criteria
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Inclusion Criteria
* Informed Consent as documented by signature
* Healed edentulous maxilla and mandible (minimum one year since last extraction)
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Frauke Müller
OTHER
Responsible Party
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Frauke Müller
Professor
Principal Investigators
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Sabrina Maniewicz, Dr
Role: PRINCIPAL_INVESTIGATOR
Research and Teaching Fellow
Locations
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University of Geneva
Geneva, Canton of Geneva, Switzerland
Countries
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Other Identifiers
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Ivotion Pilot Study
Identifier Type: -
Identifier Source: org_study_id