Clinical trial NCT05443048: Evaluation of Monolithic Milled Complete Removable Dentures
Official title: Evaluation of Monolithic Milled Complete Removable Dentures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complete Edentulism
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Esthetics
timeFrame: Baseline (BL, with existing dentures)
measure: Esthetics
timeFrame: Day 0 (T0, new dentures)
measure: Esthetics
timeFrame: 3 months (T1)
Secondary outcomes:
measure: Oral health-related quality of life
timeFrame: Baseline (BL, with existing dentures)
measure: Oral health-related quality of life
timeFrame: Day 0 (T0, new dentures)
measure: Oral health-related quality of life
timeFrame: 3 months (T1)
measure: Denture satisfaction
timeFrame: Baseline (BL, with existing dentures)
measure: Denture satisfaction
timeFrame: Day 0 (T0, new dentures)
measure: Denture satisfaction
timeFrame: 3 months (T1)
measure: Masticatory analysis
timeFrame: Baseline (BL, with existing dentures)
measure: Masticatory analysis
timeFrame: Day 0 (T0, new dentures)
measure: Masticatory analysis
timeFrame: 3 months (T1)
measure: Prosthetic Evaluation
timeFrame: Day 0 (T0, new dentures)
measure: Prosthetic Evaluation
timeFrame: 3 months (T1)
measure: Number of prosthetic maintenance needed
timeFrame: 3 months (T1)
measure: Willingness to Pay
timeFrame: 3 months (T1)
Other outcomes:
Locations:
city: Genève
country: Switzerland
facility: University of Geneva
state: GE
Study officials:
affiliation: Research and Teaching Fellow
name: Sabrina Maniewicz, Dr
role: PRINCIPAL_INVESTIGATOR
References: