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Mouth EdentulousPRIDENTPRONCT02911038

Stereolithographic Technique for Dentures

An observational study of Mouth Edentulous and Jaw Edentulous, run by Corina Marilena Cristache at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Mouth Edentulous, Jaw Edentulous
How many people
35 participants
Where
1 siteRomania
Study dates
Nov 2016to Jan 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Fully edentulous patients: maxillary, mandible or both dental arches.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Romania1 site

  • "Carol Davila"University of Medicine and Pharmacy

    Bucharest

Other trials in Romania

About this study

Official title: Stereolithographic Technique for Complete Denture Fabrication

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.

Read the 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.
Keywords
Complete denture, PMMA, Stereolithography
Medical subject headings
Mouth, Edentulous, Jaw, Edentulous

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 18 months

Secondary outcomes (3)

  1. 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".

    Measured: up to 18 months

  2. 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").

    Measured: up to 18 months

  3. 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".

    Measured: up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionSep 2017
  4. Study completionJan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02911038
Sponsor's protocol ID
CCDI-UEFISCDI 30/2016
Acronym
PRIDENTPRO
Status last verified
Jan 2018
First submitted
18 Sep 2016
Last updated
26 Jan 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 23554372

  • 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.

    PubMed 23255468

  • 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.

    PubMed 23359494

  • 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.

    PubMed 20696415

  • 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.

    PubMed 22454327

  • 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.

    PubMed 26223290

  • 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.

    PubMed 28223199

Questions about this trial

What is this clinical trial studying?

An observational study of Mouth Edentulous and Jaw Edentulous, run by Corina Marilena Cristache at 1 site in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of changes in Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT) (time frame: up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02911038, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.

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