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Accuracy of 3D Printed Maxillary Complete Dentures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03613896
Recruitment Status : Not yet recruiting
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Information provided by (Responsible Party):
Hadeer mohamed mohamed, Cairo University

Brief Summary:
Conventional complete dentures have been used for almost a century as a treatment choice for edentulous patients, despite of their inaccuracy & dimensional changes during manufacturing. Recently, new manufacturing techniques like RP/3D printing (rapid prototyping) has progressed in the dental field including prosthodontics, does the 3D printed complete denture show more accuracy than conventional ones?

Condition or disease Intervention/treatment Phase
Accuracy of 3d Printed Dentures Procedure: conventional dentures Procedure: 3d printed denture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Accuracy of 3D Printed Maxillary Complete Dentures Compared With Conventional Complete Dentures: Non-Randomized Control Trial
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arm Intervention/treatment
Placebo Comparator: conventional dentures
a complete denture made through conventional processing technique
Procedure: conventional dentures
conventional dentures

Active Comparator: 3D printed dentures
a complete denture made through 3d printing
Procedure: 3d printed denture
construction of a 3d printed denture through a recent method instead of conventional heat processing

Primary Outcome Measures :
  1. Accuracy in terms of dimensional changes in denture base [ Time Frame: immediately after denture construction ]
    we will use radio-opaque markers to measure accuracy on software

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Cooperative patients with well developed ridges..

Exclusion Criteria:

  • Pathological changes of residual ridges.
  • Patients with any systemic diseases.
  • Patients with xerostomia.
  • Patients with flabby and flat ridges.
  • Patients with allergy to resins.
  • Patient with sever undercuts, or irregular bony exostosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03613896

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Contact: Hadeer mohamed olaiwa, masters 01024455385

Sponsors and Collaborators
Cairo University

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Responsible Party: Hadeer mohamed mohamed, Principal Investigator, Cairo University Identifier: NCT03613896    
Other Study ID Numbers: hadeer`s protocol
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No