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Completed

NCT Number: NCT05443048

Evaluation of Monolithic Milled Complete Removable Dentures

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.

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Key information

Conditions

Complete Edentulism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ivoclar Ivotion Denture System

Device

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

Primary outcomes

  1. Esthetics

    Time frame: Baseline (BL, with existing dentures)

    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

  2. Esthetics

    Time frame: Day 0 (T0, new dentures)

    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. Esthetics

    Time frame: 3 months (T1)

    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

Secondary outcomes

  1. Oral health-related quality of life

    Time frame: Baseline (BL, with existing dentures)

    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

  2. Oral health-related quality of life

    Time frame: Day 0 (T0, new dentures)

    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. Oral health-related quality of life

    Time frame: 3 months (T1)

    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

  4. Denture satisfaction

    Time frame: Baseline (BL, with existing dentures)

    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

  5. Denture satisfaction

    Time frame: Day 0 (T0, new dentures)

    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

  6. Denture satisfaction

    Time frame: 3 months (T1)

    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

  7. Masticatory analysis

    Time frame: Baseline (BL, with existing dentures)

    Chewing efficiency will be evaluated with a two-color mixing ability test

  8. Masticatory analysis

    Time frame: Day 0 (T0, new dentures)

    Chewing efficiency will be evaluated with a two-color mixing ability test

  9. Masticatory analysis

    Time frame: 3 months (T1)

    Chewing efficiency will be evaluated with a two-color mixing ability test

  10. Prosthetic Evaluation

    Time frame: Day 0 (T0, new dentures)

    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

  11. Prosthetic Evaluation

    Time frame: 3 months (T1)

    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

  12. Number of prosthetic maintenance needed

    Time frame: 3 months (T1)

    events such as adjustment and repair requirements will be recorded

  13. Willingness to Pay

    Time frame: 3 months (T1)

    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.

Sponsors and collaborators

Lead sponsor

Frauke Müller

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 5, 2022
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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