Stereolithographic Technique for Dentures (PRIDENTPRO)

January 25, 2018 updated by: Corina Marilena Cristache

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania
        • "Carol Davila"University of Medicine and Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of changes in Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT)
Time Frame: up to 18 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of changes in masticatory performances assessed with Visual Analogue Scale (VAS)
Time Frame: up to 18 months
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
Evaluation of changes in denture retention with VAS
Time Frame: up to 18 months
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
Evaluation of denture changes in aesthetic aspect with VAS
Time Frame: up to 18 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corina Marilena Cristache

Collaborators

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

Investigators

  • Study Director: Eugenia Eftimie Totu, Prof., UNIV. POLITEHNICA OF BUCHAREST

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

September 18, 2016

First Submitted That Met QC Criteria

September 21, 2016

First Posted (Estimate)

September 22, 2016

Study Record Updates

Last Update Posted (Actual)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 25, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCDI-UEFISCDI 30/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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