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Completed

NCT Number: NCT02911038

Stereolithographic Technique for Dentures

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

"Carol Davila"University of Medicine and Pharmacy

Bucharest, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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".

  2. 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").

  3. 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".

Sponsors and collaborators

Lead sponsor

Corina Marilena Cristache

Other

Collaborators

  • 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

Registry information

Official study title

Stereolithographic Technique for Complete Denture Fabrication

Acronym: PRIDENTPRO

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Sep 22, 2016
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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