Stereolithographic Technique for Dentures

Jaw Edentulous Clinical Trial

— PRIDENTPRO  

Official title:

Stereolithographic Technique for Complete Denture Fabrication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02911038
• Other study ID #: CCDI-UEFISCDI 30/2016
• Status: Completed
• Phase: N/A
• First received: September 18, 2016
• Last updated: January 25, 2018
• Start date: November 2016
• Est. completion date: January 2018

Study information

• Verified date: January 2018
• Source: Concordia Dent Srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this observational study is: producing complete dental prosthesis with the aid of CAD-CAM (Computer aided design & manufacturing) - 3D printing (Stereolithography) technology - using as printable material Poli(methylmetacrylate) - PMMA - with Nano TiO2 nanoparticles composite completely characterized.

Description:

In order to improve complete dentures fabrications an experimental model for optimizing the composite material and the execution technique for the 3D printed dental prosthesis was developed.

• A new polymer - nano-TiO2 composite system for dentures printing was obtained by adding 0,4-1%TiO2 nanoparticle in the commercially available E-Dent 100 (EnvisionTEC, Germany).

• The new polymer was completely characterized and biocompatibility tests were perform.

• A stereolithography technique was set-up for CAD-CAM complete dentures manufacturing.

• 3D printed dental prosthesis will be inserted to a number of 35 complete edentulous patients from a target group;

• Clinical follow-up at 6, 12 and 18 months and quality assessment of the dentures will be recorded in a specific chart.

• A statistical evaluation of data recorded during the entire follow-up period will be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients requiring mobile or removable dentures after establishing diagnosis and treatment plan, following initial clinical and laboratory examinations,

• Persons having mental competence, decision-making capacity, legal competence.

• Patients willing to accept complete denture treatment.

• Patients with good systemic health, able to attend all the follow-up sessions.

• Patients accepting the participation in the study, including the 18 months follow-up and signing the consent form.

Exclusion Criteria:

• Patients do not agree the CAD-CAM technique for denture manufacturing.

• Patients refusing participation in the study and signing consent form.

• Patients not willing removable dental restorations.

• Patients not willing to participate at 18 months follow-up evaluation.

Related Conditions & MeSH terms

• Jaw Edentulous
• Mouth Edentulous
• Mouth, Edentulous

Locations

Country	Name	City	State
Romania	"Carol Davila"University of Medicine and Pharmacy	Bucharest

Sponsors (6)

Lead Sponsor	Collaborator
Corina Marilena Cristache	Carol Davila University of Medicine and Pharmacy, DDX Europa SRL, Bucharest, Romania, Romanian National Authority for Scientific Research and Innovation (UEFISCIDI), TURKEY MEDISEN Ltd, University Politechnica of Bucharest

Country where clinical trial is conducted

Romania, 

References & Publications (7)

Gautam R, Singh RD, Sharma VP, Siddhartha R, Chand P, Kumar R. Biocompatibility of polymethylmethacrylate resins used in dentistry. J Biomed Mater Res B Appl Biomater. 2012 Jul;100(5):1444-50. doi: 10.1002/jbm.b.32673. Epub 2012 Mar 27. Review. — View Citation

Kane RJ, Yue W, Mason JJ, Roeder RK. Improved fatigue life of acrylic bone cements reinforced with zirconia fibers. J Mech Behav Biomed Mater. 2010 Oct;3(7):504-11. doi: 10.1016/j.jmbbm.2010.05.007. Epub 2010 Jun 8. — View Citation

Kummer KM, Taylor EN, Durmas NG, Tarquinio KM, Ercan B, Webster TJ. Effects of different sterilization techniques and varying anodized TiO2 nanotube dimensions on bacteria growth. J Biomed Mater Res B Appl Biomater. 2013 Jul;101(5):677-88. doi: 10.1002/jbm.b.32870. Epub 2013 Jan 29. — View Citation

Mallineni SK, Nuvvula S, Matinlinna JP, Yiu CK, King NM. Biocompatibility of various dental materials in contemporary dentistry: a narrative insight. J Investig Clin Dent. 2013 Feb;4(1):9-19. doi: 10.1111/j.2041-1626.2012.00140.x. Epub 2012 Dec 17. Review. — View Citation

Totu EE, Nechifor AC, Nechifor G, Aboul-Enein HY, Cristache CM. Poly(methyl methacrylate) with TiO(2) nanoparticles inclusion for stereolitographic complete denture manufacturing - the fututre in dental care for elderly edentulous patients? J Dent. 2017 A — View Citation

Tsuji M, Ueda T, Sawaki K, Kawaguchi M, Sakurai K. Biocompatibility of a titanium dioxide-coating method for denture base acrylic resin. Gerodontology. 2016 Dec;33(4):539-544. doi: 10.1111/ger.12204. Epub 2015 Jul 30. — View Citation

Wang Y, Wen C, Hodgson P, Li Y. Biocompatibility of TiO2 nanotubes with different topographies. J Biomed Mater Res A. 2014 Mar;102(3):743-51. doi: 10.1002/jbm.a.34738. Epub 2013 Jun 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of changes in Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT)	OHIP-EDENT-RO, validated for Romanian language questionnaire will be administrated at denture insertion and at 6, 12, 18 month follow-up	up to 18 months
Secondary	Evaluation of changes in masticatory performances assessed with Visual Analogue Scale (VAS)	At 6, 12 and 18 months clinical follow-up masticatory performance will be evaluated using VAS with units from 0 to 10 where 0 is "totally satisfied" and 10 is "not at all satisfied".	up to 18 months
Secondary	Evaluation of changes in denture retention with VAS	At 6, 12 and 18 months denture retention will be evaluated using VAS with units from 0 to 10 where 0 is "strong retention" ("totally satisfied") and 10 is "poor retention"("not at all satisfied").	up to 18 months
Secondary	Evaluation of denture changes in aesthetic aspect with VAS	At 6, 12 and 18 months denture aesthetic will be evaluated using VAS with units from 0 to 10 where 0 is "totally satisfied" and 10 is "not at all satisfied".	up to 18 months

External Links

•   Link to the PRIDENTPRO project.