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Complete Denture Tooth Movement in Digital Light Processing Versus Conventional Fabrication Techniques

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: NCT04025697
Recruitment Status : Not yet recruiting
First Posted : July 19, 2019
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Shaymaa Belety, Cairo University

Brief Summary:

The purposes of this study are to compare the denture tooth movement, the amount of occlusal adjustment needed and the chairside time required for CAD-CAM and conventional dentures.

PICOT Format:

P: completely edentulous patients. I: Complete denture fabricated by digital light processing method. C: Complete denture fabricated by the conventional method.

O:

Primary Outcome: Denture tooth movement

Secondary outcomes:

  • Amount of occlusal adjustments needed
  • Chairside time T: Three months with a wash-up period of 2 weeks

Condition or disease Intervention/treatment Phase
Rapid Prototyping in Dentures Other: Complete Denture Other: Rapid prototyped denture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Complete Denture Tooth Movement in Digital Light Processing Versus Conventional Fabrication Techniques: A Randomized Controlled Trial
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arm Intervention/treatment
Placebo Comparator: Conventional CD
A conventional Complete denture will be constructed and the amount of denture tooth movement will be measured
Other: Complete Denture
A conventional CD will be constructed

Active Comparator: Rapid Prototyped Denture
A digital light processed denture will be constructed and the amount of tooth movement will be measured
Other: Rapid prototyped denture
A 3d printed complete denture will be constructed




Primary Outcome Measures :
  1. The amount of tooth movement [ Time Frame: 8 months ]

    The amount of tooth movement will be measured immediately after denture construction using the Geomagic surface matching software (Geomagic Control 2014; 3D Systems Inc.) Laser scan images of the denture obtained both after trial setup of teeth and of the final denture after being hydrated for 24 hours. Those images will be transferred into STL files that will then be superimposed using the global registration function of the software by finding 10,000 points in common between both pre and pot processing STL files.

    Measurements will be made at different points using the software and colour surface maps will be created using the 3D comparison function to display the amount and direction of tooth movement




Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ranging from 40-70 years.
  • Cooperative patients with no history of psychological diseases.
  • Completely edentulous patients with types I, II and III mandibles according to McGarry et al.

Exclusion Criteria:

  • Pathological changes of residual ridges
  • Patients with xerostomia.
  • Patients with flabby ridges.
  • Temporomandibular disorders and neuromuscular disorders e.g. Parkinson's disease

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): NCT04025697


Contacts
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Contact: Shaymaa M Belety +201224101002 sbelety@hotmail.com

Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Iman A Radi Cairo University

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Responsible Party: Shaymaa Belety, Assistant Lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT04025697    
Other Study ID Numbers: Rapid Prototyping Dentures
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019

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