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

NCT04023006 | Terminated FDA Device

• 1 other identifier: PRPA 22901 / CR 02
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Mouth, Edentulous

Keywords

Denture

Outcome Measures

Primary Outcomes (1)

• Assessment of the fit of the denture

  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)

  At Final Placement of Denture, through study completion, an average of one month

Secondary Outcomes (3)

• Aesthetics of dentures

  At Final Placement of Denture,through study completion, an average of one month

• Function of dentures

  At Final Placement of Denture,through study completion, an average of 1 month

• Dentist's satisfaction with treatment: questionnaire

  At Final Placement of Denture, through study completion, an average of 1 month

Study Arms (1)

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

Interventions

Removable prostheses DEVICE

Full dentures created by Additive manufacturing (Carbon Printers)

Also known as: Lucitone 3D print resin dentures

Edentulous Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dentsply International: lead

Study Sites (1)

Boston University Goldman School of Dental MEdicine

Boston, Massachusetts, 02118, United States

Location

Related Publications (2)

• Celebic A, Knezovic-Zlataric D, Papic M, Carek V, Baucic I, Stipetic J. Factors related to patient satisfaction with complete denture therapy. J Gerontol A Biol Sci Med Sci. 2003 Oct;58(10):M948-53. doi: 10.1093/gerona/58.10.m948.

  PMID: 14570864 BACKGROUND

• Schwindling FS, Bomicke 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.

  PMID: 24057919 BACKGROUND

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 17, 2019
• Study Start: August 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)