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

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ClinicalTrials.gov Identifier: NCT04023006
Recruitment Status : Not yet recruiting
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Dentsply International

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.


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Study Type : Observational
Estimated 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
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

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




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)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023006


Contacts
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Contact: Kathleen A Catanzaro 609-845-8457 kathleen.catanzaro@dentsplysirona.com
Contact: Clark Smith, Dr. 1-816-678-1808 Clark.smith@dentsplysirona.com

Locations
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United States, Massachusetts
Boston University Goldman School of Dental MEdicine Not yet recruiting
Boston, Massachusetts, United States, 02118
Contact: Alexander Bendayan, DMD    617-358-5067    bendayan@bu.edu   
Contact: Sarahanne Sohm    617-358-8300    sasohm@bu.edu   
Principal Investigator: Alexander Bendayan, DMD         
Sub-Investigator: Ronnie A Schnell, DMD         
Sponsors and Collaborators
Dentsply International

Publications:
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Responsible Party: Dentsply International
ClinicalTrials.gov Identifier: NCT04023006     History of Changes
Other Study ID Numbers: PRPA 22901 / CR 02
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dentsply International:
Denture

Additional relevant MeSH terms:
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Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases