Sponsor study identifier
interventional
10
1 country
1
Study Start
September 1, 2022
Actual (reported)Primary Completion
August 31, 2023
Actual (reported)Study Completion
August 31, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2023
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 21, 2022
Actual (reported)July 5, 2022
Actual (reported)September 1, 2022
Actual (reported)August 31, 2023
Actual (reported)August 31, 2023
Actual (reported)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)
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)
Fabrication of maxillary and mandibular complete removable dental prosthesis with the Ivoclar Ivotion Denture System
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Geneva
Geneva, Canton of Geneva, 1211, Switzerland
Sabrina Maniewicz, Dr
Research and Teaching Fellow
10 participants (actual enrollment reported by the registry).
First Submitted
June 21, 2022
First Posted
July 5, 2022
Study Start
September 1, 2022
Actual (reported)Simplified Technique in Removable Complete Prosthesis Versus Conventional Technique in Edentulous Patients
Contact the study team to confirm eligibility.
Primary Completion
August 31, 2023
Actual (reported)Study Completion
August 31, 2023
Actual (reported)Last Updated
December 17, 2024
Record last verified: 2022-06
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Source: ClinicalTrials.gov.
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