Stereolithographic Technique for Dentures
PRIDENTPRO
1 other identifier
observational
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2016
CompletedFirst Posted
Study publicly available on registry
September 22, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedJanuary 26, 2018
January 1, 2018
10 months
September 18, 2016
January 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Evaluation of changes in masticatory performances assessed with Visual Analogue Scale (VAS)
up to 18 months
Evaluation of changes in denture retention with VAS
up to 18 months
Evaluation of denture changes in aesthetic aspect with VAS
up to 18 months
Eligibility Criteria
Fully edentulous patients: maxillary, mandible or both dental arches.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Corina Marilena Cristachelead
- Carol Davila University of Medicine and Pharmacycollaborator
- Romanian National Authority for Scientific Research and Innovation (UEFISCIDI)collaborator
- University Politechnica of Bucharestcollaborator
- TURKEY MEDISEN Ltdcollaborator
- DDX Europa SRL, Bucharest, Romaniacollaborator
Study Sites (1)
"Carol Davila"University of Medicine and Pharmacy
Bucharest, Romania
Related Publications (7)
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.
PMID: 23554372BACKGROUNDMallineni 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.
PMID: 23255468BACKGROUNDKummer 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.
PMID: 23359494BACKGROUNDKane 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.
PMID: 20696415BACKGROUNDGautam 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.
PMID: 22454327BACKGROUNDTsuji 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.
PMID: 26223290BACKGROUNDTotu 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.
PMID: 28223199RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eugenia Eftimie Totu, Prof.
UNIV. POLITEHNICA OF BUCHAREST
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Senior Lecturer, PhD, Dr
Study Record Dates
First Submitted
September 18, 2016
First Posted
September 22, 2016
Study Start
November 1, 2016
Primary Completion
September 1, 2017
Study Completion
January 1, 2018
Last Updated
January 26, 2018
Record last verified: 2018-01