Evaluation of Monolithic Milled Complete Removable Dentures

NCT05443048 | Completed

• 1 other identifier: Ivotion Pilot Study
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Complete Edentulism

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• Oral health-related quality of life

  Baseline (BL, with existing dentures)

• Oral health-related quality of life

  Day 0 (T0, new dentures)

• Oral health-related quality of life

  3 months (T1)

• Denture satisfaction

  Baseline (BL, with existing dentures)

• Denture satisfaction

  Day 0 (T0, new dentures)

Study Arms (1)

Ivoclar Ivotion Denture System

EXPERIMENTAL

Device: Ivoclar Ivotion Denture System

Interventions

Ivoclar Ivotion Denture System DEVICE

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

Ivoclar Ivotion Denture System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Informed Consent as documented by signature
• Healed edentulous maxilla and mandible (minimum one year since last extraction)

You may not qualify if:

• 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

Sponsors & Collaborators

• Frauke Müller: lead

Study Sites (1)

University of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location

Study Officials

• Sabrina Maniewicz, Dr

  Research and Teaching Fellow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 5, 2022
• Study Start: September 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: December 17, 2024

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)