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出境医 / 临床实验 / An Observational Clinical Case Series Study to Assess Fit and Quality of Full Dentures Fabricated by AM

An Observational Clinical Case Series Study to Assess Fit and Quality of Full Dentures Fabricated by AM

Study Description
Brief Summary:
This observational clinical case series investigation will be conducted on approximately five (5) enrolled subjects at one (1) site in the US. Treatment of subjects encompasses all steps to fabricate new dentures for maxilla and/or mandible. The subjects will be followed 7-10 days after final delivery of the denture

Condition or disease Intervention/treatment
Mouth, Edentulous Device: Removable prostheses

Detailed Description:

This investigation is undertaken to evaluate the workflow and concomitant products to create full dentures by using additive manufacturing (AM) technology, i.e. Digital Light Processing™ Technology (Carbon 3D) to restore fully edentulous jaws. The assessment includes quality of materials provided by Dentsply Sirona Lab by using printers for AM (M series, Carbon 3D 1089 Mills Way, Redwood City, CA 94063). This assessment will be done by clinical review of the AM dentures on fit and quality. In addition, the evaluation includes a patient survey to assess current dentures and the new AM dentures with a subjective comparison of both.

The target subjects are male or female, 18 years and older with the need of a full denture in one or both jaws, being completely edentulous. The newly fabricated denture is to replace an existing full denture. For this descriptive study, no minimum number of patients is defined, but to achieve a reasonable subject number, a minimum of five (5) and a maximum of ten (10) patients will be enrolled, i.e. ten to twenty (10-20) denture arches will be fabricated within this study.

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Observational Clinical Case Series Study to Assess Fit and Quality of Full Dentures
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020
Arms and Interventions
Group/Cohort Intervention/treatment
Edentulous Patients
The investigational device is part of a treatment concept for edentulous patients of all ages, gender and races. The incidence for tooth loss has not declined over years, and the prevalence for edentulism is significantly higher for adults 50 years and older. For this descriptive two-part survey, no minimum number of patients is defined, but to achieve a reasonable subject number, a minimum of five (5) patients will be enrolled, i.e. 10 dentures will be fabricated within this study.
 Device: Removable prostheses
Full dentures created by Additive manufacturing (Carbon Printers)
Other Name: Lucitone 3D print resin dentures
Outcome Measures
Primary Outcome Measures :
  1. Assessment of the fit of the denture [ Time Frame: At Final Placement of Denture, through study completion, an average of one month ]

    A questionnaire of assessment of fit by ranking, in comparison to the previous denture, using a Likert Scale from a minimum of 5 to a maximum of 1.

    Much worse (5) Worse (4) Same (3) Better (2) Much better (1)



Secondary Outcome Measures :
  1. Aesthetics of dentures [ Time Frame: At Final Placement of Denture,through study completion, an average of one month ]

    A questionnaire of assessment of aesthetics by ranking, in comparison to the previous denture, using a Likert Scale from a minimum of 5 to a maximum of 1.

    Much worse (5) Worse (4) Same (3) Better (2) Much better (1)


  2. Function of dentures [ Time Frame: At Final Placement of Denture,through study completion, an average of 1 month ]

    A questionnaire of assessment of function by ranking, in comparison to the previous denture, using a Likert Scale from a minimum of 5 to a maximum of 1.

    Much worse (5) Worse (4) Same (3) Better (2) Much better (1)


  3. Dentist's satisfaction with treatment: questionnaire [ Time Frame: At Final Placement of Denture, through study completion, an average of 1 month ]

    A questionnaire of assessment of satisfactions of treatment by ranking, in comparison to the previous placed denture, using a Likert Scale from a minimum of 5 to a maximum of 1.

    Much worse (5) Worse (4) Same (3) Better (2) Much better (1)



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The investigational device is part of a treatment concept for edentulous patients of all ages, gender and races. The incidence for tooth loss has not declined over years, and the prevalence for edentulism is significantly higher for adults 50 years and older. For this descriptive two-part survey, no minimum number of patients is defined, but to achieve a reasonable subject number, a minimum of five (5) patients will be enrolled, i.e. 10 dentures will be fabricated within this study.
Criteria

Inclusion Criteria:

  • Subject is 18 years or older.
  • Subject has given written consent to participate in the trial.
  • Subject is in good general health.
  • Subject requires a new removable full denture for both jaws.
  • Subject is completely edentulous in the maxilla and mandible.
  • Subject is already wearing a full denture in the maxilla and mandible.
  • Subject is willing to undergo dental treatment to receive a new full denture for both jaws.
  • Subject confirms availability for treatment and all indicated follow-up visits.

Exclusion Criteria:

  • Subject is younger than 18 years.
  • Subject is pregnant.
  • Subject has disabilities that do not allow a regular dental treatment.
  • Subject with some systemic medical complications that cause difficulty in impression taking or judging occlusion of device.
  • Subject is currently participating in another study.
  • Subject has an allergic history regarding materials used in this trial.
  • Subject with xerostomia/ dry-mouth syndrome.
  • Lack of compliance is expected.
  • Those subjects who cannot provide informed consent for any reason
  • Acute stomatitis.
  • Status after tumor treatment in head-neck region (removal, radiotherapy).
  • Acute cancer.
  • Incomplete hard and/or soft tissue in the oral cavity.
  • Muscle and/or nerve damage in the head-neck region.
  • Insufficient vertical height and/or insufficient mouth opening.
  • Resilient hyperplastic mucosa ("flappy ridges").
  • Bruxism.
  • Insufficient oral hygiene. The existing dentures should have no visible calculus.
  • Previously enrolled in the present investigation.
  • Involvement in the planning and conduct of the clinical investigation. (applies to all Dentsply Sirona & Carbon 3D staff, investigational site staff staff and third party vendor).
Contacts and Locations

Locations
Layout table for location information
United States, Massachusetts
Boston University Goldman School of Dental MEdicine
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Dentsply International
Tracking Information
First Submitted Date July 12, 2019
First Posted Date July 17, 2019
Last Update Posted Date February 10, 2021
Actual Study Start Date August 1, 2019
Actual Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 15, 2019) 		Assessment of the fit of the denture [ Time Frame: At Final Placement of Denture, through study completion, an average of one month ]
A questionnaire of assessment of fit by ranking, in comparison to the previous denture, using a Likert Scale from a minimum of 5 to a maximum of 1. Much worse (5) Worse (4) Same (3) Better (2) Much better (1)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 15, 2019)
  • Aesthetics of dentures [ Time Frame: At Final Placement of Denture,through study completion, an average of one month ]
    A questionnaire of assessment of aesthetics by ranking, in comparison to the previous denture, using a Likert Scale from a minimum of 5 to a maximum of 1. Much worse (5) Worse (4) Same (3) Better (2) Much better (1)
  • Function of dentures [ Time Frame: At Final Placement of Denture,through study completion, an average of 1 month ]
    A questionnaire of assessment of function by ranking, in comparison to the previous denture, using a Likert Scale from a minimum of 5 to a maximum of 1. Much worse (5) Worse (4) Same (3) Better (2) Much better (1)
  • Dentist's satisfaction with treatment: questionnaire [ Time Frame: At Final Placement of Denture, through study completion, an average of 1 month ]
    A questionnaire of assessment of satisfactions of treatment by ranking, in comparison to the previous placed denture, using a Likert Scale from a minimum of 5 to a maximum of 1. Much worse (5) Worse (4) Same (3) Better (2) Much better (1)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Clinical Case Series Study to Assess Fit and Quality of Full Dentures Fabricated by AM
Official Title An Observational Clinical Case Series Study to Assess Fit and Quality of Full Dentures
Brief Summary This observational clinical case series investigation will be conducted on approximately five (5) enrolled subjects at one (1) site in the US. Treatment of subjects encompasses all steps to fabricate new dentures for maxilla and/or mandible. The subjects will be followed 7-10 days after final delivery of the denture
Detailed Description

This investigation is undertaken to evaluate the workflow and concomitant products to create full dentures by using additive manufacturing (AM) technology, i.e. Digital Light Processing™ Technology (Carbon 3D) to restore fully edentulous jaws. The assessment includes quality of materials provided by Dentsply Sirona Lab by using printers for AM (M series, Carbon 3D 1089 Mills Way, Redwood City, CA 94063). This assessment will be done by clinical review of the AM dentures on fit and quality. In addition, the evaluation includes a patient survey to assess current dentures and the new AM dentures with a subjective comparison of both.

The target subjects are male or female, 18 years and older with the need of a full denture in one or both jaws, being completely edentulous. The newly fabricated denture is to replace an existing full denture. For this descriptive study, no minimum number of patients is defined, but to achieve a reasonable subject number, a minimum of five (5) and a maximum of ten (10) patients will be enrolled, i.e. ten to twenty (10-20) denture arches will be fabricated within this study.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The investigational device is part of a treatment concept for edentulous patients of all ages, gender and races. The incidence for tooth loss has not declined over years, and the prevalence for edentulism is significantly higher for adults 50 years and older. For this descriptive two-part survey, no minimum number of patients is defined, but to achieve a reasonable subject number, a minimum of five (5) patients will be enrolled, i.e. 10 dentures will be fabricated within this study.
Condition Mouth, Edentulous
Intervention Device: Removable prostheses
Full dentures created by Additive manufacturing (Carbon Printers)
Other Name: Lucitone 3D print resin dentures
Study Groups/Cohorts Edentulous Patients
The investigational device is part of a treatment concept for edentulous patients of all ages, gender and races. The incidence for tooth loss has not declined over years, and the prevalence for edentulism is significantly higher for adults 50 years and older. For this descriptive two-part survey, no minimum number of patients is defined, but to achieve a reasonable subject number, a minimum of five (5) patients will be enrolled, i.e. 10 dentures will be fabricated within this study.
Intervention: Device: Removable prostheses
Publications *
  • Celebić A, Knezović-Zlatarić D, Papić M, Carek V, Baucić I, Stipetić J. Factors related to patient satisfaction with complete denture therapy. J Gerontol A Biol Sci Med Sci. 2003 Oct;58(10):M948-53.
  • Schwindling FS, Bömicke W, Hassel AJ, Rammelsberg P, Stober T. Randomized clinical evaluation of a light-cured base material for complete dentures. Clin Oral Investig. 2014;18(5):1457-65. doi: 10.1007/s00784-013-1110-4. Epub 2013 Sep 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: July 15, 2019) 		10
Original Estimated Enrollment Same as current
Actual Study Completion Date April 1, 2020
Actual Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subject is 18 years or older.
  • Subject has given written consent to participate in the trial.
  • Subject is in good general health.
  • Subject requires a new removable full denture for both jaws.
  • Subject is completely edentulous in the maxilla and mandible.
  • Subject is already wearing a full denture in the maxilla and mandible.
  • Subject is willing to undergo dental treatment to receive a new full denture for both jaws.
  • Subject confirms availability for treatment and all indicated follow-up visits.

Exclusion Criteria:

  • Subject is younger than 18 years.
  • Subject is pregnant.
  • Subject has disabilities that do not allow a regular dental treatment.
  • Subject with some systemic medical complications that cause difficulty in impression taking or judging occlusion of device.
  • Subject is currently participating in another study.
  • Subject has an allergic history regarding materials used in this trial.
  • Subject with xerostomia/ dry-mouth syndrome.
  • Lack of compliance is expected.
  • Those subjects who cannot provide informed consent for any reason
  • Acute stomatitis.
  • Status after tumor treatment in head-neck region (removal, radiotherapy).
  • Acute cancer.
  • Incomplete hard and/or soft tissue in the oral cavity.
  • Muscle and/or nerve damage in the head-neck region.
  • Insufficient vertical height and/or insufficient mouth opening.
  • Resilient hyperplastic mucosa ("flappy ridges").
  • Bruxism.
  • Insufficient oral hygiene. The existing dentures should have no visible calculus.
  • Previously enrolled in the present investigation.
  • Involvement in the planning and conduct of the clinical investigation. (applies to all Dentsply Sirona & Carbon 3D staff, investigational site staff staff and third party vendor).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04023006
Other Study ID Numbers PRPA 22901 / CR 02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dentsply International
Study Sponsor Dentsply International
Collaborators Not Provided
Investigators Not Provided
PRS Account Dentsply International
Verification Date February 2021

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