A Descriptive, Prospective Clinical Study to Evaluate Full Dentures Fabricated by Additive Manufacturing

Mouth, Edentulous Clinical Trial

Official title:

A Descriptive, Prospective Clinical Study to Evaluate Fit and Quality of Full Dentures Fabricated by Additive Manufacturing

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03997604
• Other study ID #: PRPA2290/CR-01
• Status: Withdrawn
• Start date: May 29, 2019
• Est. completion date: October 29, 2022

Study information

• Verified date: August 2022
• Source: Dentsply International
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 Additive Manufacturing (M2 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 trial includes a patient survey to assess current dentures and the new AM dentures with a subjective comparison of both.

Description:

Study Design: - This descriptive, prospective, clinical investigation will be conducted on approximately forty (40) enrolled subjects at four (4) sites in the US. - Treatment of subjects encompasses all steps to fabricate new dentures for maxilla and mandible (no greater than five (5) visits; 30-60 min. chair time per appointment). - The subjects will be followed 7-10 days after final delivery of the denture for function check. - Long-term follow-up will be performed after 6 months, 12 months, 24 months and 36 months to assess fit, function, and esthetics under function performed by the dental professional and by capturing according feedback by the patient.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 29, 2022
• Est. primary completion date: October 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 sift 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/Affordable staff and third party vendor).

Related Conditions & MeSH terms

• Mouth, Edentulous

Intervention

Device:
• Full Dentures created by additive manufacturing
Full dentures created by Additive manufacturing (Carbon Printers)

Locations

Country	Name	City	State
United States	Wagner Denture Group 801 Encino Pl NE A3	Albuquerque	New Mexico
United States	Affordable Dentures and Implants	Northglenn	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply International

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of the fit of the denture	Assessment of the fit of the new dentures in comparison to the previous prostheses in the mouth immediately after first insertion by dentist. A questionnaire of Assessment of fit by ranking from; Much worse; Worse; Same; Better; Much better	7 days after final placement of dentures
Secondary	Aesthetics of dentures	patients overall satisfactions of the dentures aesthetics. A questionnaire of assessment of fit by ranking from; Much worse; Worse; Same; Better; Much better	7 days after final placement of dentures
Secondary	Function of dentures	patients overall satisfaction of dentures to masticate. Assessment of fit by ranking from; Much worse; Worse; Same; Better; Much better	7 days after final placement of dentures
Secondary	Patient's satisfaction with denture and treatment	Patients are asked to compare existing and new denture by using a survey. a Questionnaire Assessment of fit by ranking from; Much worse; Worse; Same; Better; Much better	36 months after final placement
Secondary	Dentist's satisfaction with treatment	Assessment of treatment process in comparison to traditional denture fabrication process. A questionnaire Assessment of fit by ranking from; Much worse; Worse; Same; Better; Much better	7 Days after final placement
Secondary	Health of oral cavity and related tissues	Continuously clinical intra-oral inspection of oral landmarks and tissues with regard to any findings. ** *parameters according to Grandmont, ** Scottish Dental effectiveness program. Assessment of by scoring: pigmented; ulcus; white; red; swelling; negative	36 months after final placement