Clinical trial NCT02911038: Stereolithographic Technique for Dentures
Official title: Stereolithographic Technique for Complete Denture Fabrication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mouth Edentulous
Jaw Edentulous
Keywords: Complete denture
PMMA
Stereolithography
Lead sponsor: Concordia Dent Srl
Sponsor class: OTHER
Collaborators: name: Carol Davila University of Medicine and Pharmacy
name: Romanian National Authority for Scientific Research and Innovation (UEFISCIDI)
name: University Politechnica of Bucharest
name: TURKEY MEDISEN Ltd
name: DDX Europa SRL, Bucharest, Romania
First posted: 2016-09-22
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fully edentulous patients: maxillary, mandible or both dental arches.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of changes in Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT)
timeFrame: up to 18 months
Secondary outcomes:
measure: Evaluation of changes in masticatory performances assessed with Visual Analogue Scale (VAS)
timeFrame: up to 18 months
measure: Evaluation of changes in denture retention with VAS
timeFrame: up to 18 months
measure: Evaluation of denture changes in aesthetic aspect with VAS
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: "Carol Davila"University of Medicine and Pharmacy
Study officials:
affiliation: UNIV. POLITEHNICA OF BUCHAREST
name: Eugenia Eftimie Totu, Prof.
role: STUDY_DIRECTOR
References:
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.
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.
citation: Kummer KM, Taylor EN, Durmas NG, Tarquinio KM, Ercan B, Webster TJ. Effects of different sterilization techniques and varying anodized TiO(2) 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.
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.
citation: 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.
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.
citation: Totu EE, Nechifor AC, Nechifor G, Aboul-Enein HY, Cristache CM. Poly(methyl methacrylate) with TiO2 nanoparticles inclusion for stereolitographic complete denture manufacturing - the fututre in dental care for elderly edentulous patients? J Dent. 2017 Apr;59:68-77. doi: 10.1016/j.jdent.2017.02.012. Epub 2017 Feb 20.