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Retention of Complete Denture Using Rapid Prototyping

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: NCT03507179
Recruitment Status : Not yet recruiting
First Posted : April 24, 2018
Last Update Posted : April 24, 2018
Information provided by (Responsible Party):
lina khalaf, Cairo University

Brief Summary:

Nineteen patients will be selected from the clinic following the inclusion and exclusion criteria. Each one of them will receive two dentures. The first denture will be a conventional complete denture while the second denture will be a complete denture made by Rapid prototyping method.

For both groups, a preliminary impression will be made & after pouring the primary impression, self-cured acrylic resin trial denture bases with a wax rim will be constructed on the primary casts for the upper & lower arches for a jaw relation record. A facebow record will be used to mount the upper cast, while the lower cast will be mounted using a centric relation record. Setting of artificial teeth will be performed, then the denture will be tried in patient`s mouth. Functional impression will be taken during the try in stage which.

For the first denture, the functional impression will be poured in normal way to obtain the master cast. Then Processing will be done in normal way and the denture will be finished and polished and delivered to the patient.

But for the second denture construction CBCT scanning of the try in with the functional impression will be done to obtain STL file then denture base manufacturing will be done by 3D printing.

For group A and group B Retention will be measured for the upper denture immediately, with a wash out period one month between the two dentures.

Condition or disease Intervention/treatment Phase
Retention of 3D Printed Dentures Other: 3d printed denture Other: conventional dentures Not Applicable

Detailed Description:
Heat processed denture base is the treatment of choice for most of edentulous patients and it is considered as the golden standard and the main comparator for the new techniques. But using Heat Cured Acrylic resin would require many laboratory steps which introduce several errors . Meanwhile, the introduction of rapid prototyping method with high accuracy which eliminates some of the laboratory steps was the reason for choosing it to compare it with the conventional method.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Retention of Complete Denture Using Rapid Prototyping Versus a Conventional Complete Denture: Cross Over Randomized Control Trial
Estimated Study Start Date : May 4, 2018
Estimated Primary Completion Date : October 4, 2018
Estimated Study Completion Date : November 4, 2018

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
Other: conventional dentures
conventional dentures

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

Primary Outcome Measures :
  1. retention [ Time Frame: immediately after denture construction ]
    We will Determine the geographic center for upper denture base to measure retention then A loop will be attached to each denture base at the position of geographic center using clear self cure acrylic resin and the retention will be measured by applying the forces perpendicular to the denture using Digital Force Meter Each base will be tested 3 times and the average will be calculated. Then the loop will be removed and the denture will finished and polish. Retention will be measured immediately after denture insertion.

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:   Yes

Inclusion Criteria:

  1. Age ranging from 40-70 years.
  2. Cooperative patients.
  3. male or female patients

Exclusion Criteria:

  1. Pathological changes of residual ridges.
  2. Patients with any systemic diseases.
  3. Patients with xerostomia.
  4. Patients with flabby and flat ridges.
  5. Patients with allergy to resins.
  6. 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): NCT03507179

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Contact: lina ismail, masters 01092468850

Sponsors and Collaborators
Cairo University

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Responsible Party: lina khalaf, teaching assistant, Cairo University Identifier: NCT03507179    
Other Study ID Numbers: lina''s protocol
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 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