Evaluation of Monolithic Milled Complete Removable Dentures

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Monolithic Milled Complete Removable Dentures

Conditions
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Complete Edentulism

Intervention / Treatment
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* Device: Ivoclar Ivotion Denture System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Informed Consent as documented by signature Healed edentulous maxilla and mandible (minimum one year since last extraction) Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ivoclar Ivotion Denture System<br> | Device: Ivoclar Ivotion Denture System<br>* Fabrication of maxillary and mandibular complete removable dental prosthesis with the Ivoclar Ivotion Denture System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 3 months (T1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | 3 months (T1) | 
| Masticatory analysis | Chewing efficiency will be evaluated with a two-color mixing ability test | Baseline (BL, with existing dentures) | 
| Masticatory analysis | Chewing efficiency will be evaluated with a two-color mixing ability test | Day 0 (T0, new dentures) | 
| Masticatory analysis | Chewing efficiency will be evaluated with a two-color mixing ability test | 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 | 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 | 3 months (T1) | 
| Number of prosthetic maintenance needed | events such as adjustment and repair requirements will be recorded | 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. | 3 months (T1) |