Evaluation of Monolithic Milled Complete Removable Dentures

Complete Edentulism Clinical Trial

Official title:

Evaluation of Monolithic Milled Complete Removable Dentures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05443048
• Other study ID #: Ivotion Pilot Study
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: June 2022
• Source: University of Geneva, Switzerland
• Contact: Frauke Müller, Pr
• Phone: +41 22 379 40 60
• Email: frauke.mueller[@]unige.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complete Edentulism

Intervention

Device:
• Ivoclar Ivotion Denture System
Fabrication of maxillary and mandibular complete removable dental prosthesis with the Ivoclar Ivotion Denture System

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Frauke Müller

Outcome

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