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Patient Satisfaction and Retention of Upper Complete Denture Base Using Rapid Prototyping Versus a Conventional One

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.
 
ClinicalTrials.gov Identifier: NCT03354715
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Omar Mahmoud Youssef, Cairo University

Brief Summary:
Comparing patient satisfaction and retention of upper complete denture fabricated using two different denture base materials, the first fabricated using rapid prototyping method while the second is following conventional methods.

Condition or disease Intervention/treatment Phase
Complete Denture Device: Rapid prototyping Denture base Device: Heat Cured Conventional Complete Denture Not Applicable

Detailed Description:

Searching for other materials or other fabrication technologies has been one of the goals to help to re-innovate the fabrication of complete dentures , which would greatly influence completely edentulous Patient satisfaction. The introduction of rapid prototyping (RP)Stereo lithography (SLA) technology has many advantage as high accuracy, high mechanical strength, smooth surface finish with close tolerance and fine details printing, but it has some limitation as it is only limited Material, in addition to the high material and equipment cost.

SLA has been used in dental fields like maxillofacial prosthesis , wax pattern fabrication for crown bridge , removable partial denture 19, but still complete denture was reported in a very few reports indicating that RP is not yet successfully applied in Complete denture manufacturing 19-21A randomised trial is therefore needed to asses accurately wether the introduction of rapid prototyping in complete denture fabrication is successful or not in comparison to the conventional technique and to discover the possible challenges in this recent technique and the ways to overcome it.

Retention of complete dentures and patient satisfaction has been reported in many studies22-26. Patients have showed a higher satisfaction, as retention of both maxillary and mandibular complete dentures increased.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Patient Satisfaction and Retention of Upper Complete Denture Base Using Rapid Prototyping Versus a Conventional One: Randomized Control Trial
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arm Intervention/treatment
Sham Comparator: Rapid prototyping Denture base
Complete Denture Using Rapid Prototyping method for fabrication of the complete denture depending on
Device: Rapid prototyping Denture base
The introduction of rapid prototyping (RP)Stereo lithography (SLA) technology, which mainly depends on addition of layers of materials which would be polymerized using a light curing unit. It consists of a bath of photo polymerized liquid and ultraviolet unit for curing these layers, that would bond to each other till forming the full object. SLA has many advantage as high accuracy, high mechanical strength, smooth surface finish with close tolerance and fine details printing, but it has some limitation as it is only limited Material, in addition to the high material and equipment cost.

Sham Comparator: Heat Cured Conventional Complete Denture
Complete Denture using heat cured Denture base using flasking and deflasking method
Device: Heat Cured Conventional Complete Denture
it is the main treatment for most of completely edentoulous Cases




Primary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: 3 month ]
    Patient Satisfaction Questionnaire using likert scale five points represent degree of satisfaction and compare the result to each other


Secondary Outcome Measures :
  1. Retention [ Time Frame: 3 month ]
    resistance to tissue away movement using digital force meter and recording the average of 10 reading in one time and compare the results of the two denture



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  1. Age ranging from 40-70 years.
  2. Patients who can understand and respond to a written questionnaire in Arabic.
  3. Cooperative patients

Exclusion Criteria:

  1. Pathological changes of residual ridges.
  2. Patients with debilitating systemic diseases.
  3. Patients with xerostomia.
  4. Patients with flabby and flat ridges.
  5. Patients with allergy to acrylic resin
  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 ClinicalTrials.gov identifier (NCT number): NCT03354715


Locations
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Egypt
Faculty of Dentistry Recruiting
CAiro, Egypt, 111789
Contact: Atef AS Shaker, dr    23634965    atefshaker@dentistry.cu.edu.eg   
Sponsors and Collaborators
Cairo University

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Responsible Party: Omar Mahmoud Youssef, Master Student, Cairo University
ClinicalTrials.gov Identifier: NCT03354715    
Other Study ID Numbers: 2717
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 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
Product Manufactured in and Exported from the U.S.: No