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Retention of Computer Aided Design and Computer Aided Manufacturing Titanium Versus Co/Cr Single 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.
 
ClinicalTrials.gov Identifier: NCT03675594
Recruitment Status : Not yet recruiting
First Posted : September 18, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Amr Gamal Ismail Mohamed, Cairo University

Brief Summary:
  • Steps in short: Undergoing the conventional steps of maxillary single denture construction till the step of framework construction that will be designed and constructed using CAD/CAM after optical scanning of the master cast ( 2 frameworks to cover the palate and crest of the ridge : one made of titanium and the other made of cobalt/chromium) then conventional steps will be undergone including bite, Try-in and delivery ending by measuring the denture retention.
  • Number of visits & follow up period :

Visits: will be 5-6 visits for each patient. Follow up period: 6.5 months (immediately post-insertion then after 1 week then after 3 months for the first type then 2 weeks washout period and the same for the second type)


Condition or disease Intervention/treatment Phase
Edentulous Mouth Device: CAD/CAM titanium denture base Device: CAD/CAM cobalt/chromium denture bases Not Applicable

Detailed Description:

The study will be carried out in the department of prosthodontics-cairo university. Patients will be selected from the out-patient clinic according to the inclusion criteria, The primary impression will be made with alginate (cavex-normal set) and will be border-molded to get the acceptable extension and border thickness, a tray will be prepared with self-activated acrylic resin over the study cast. A secondary impression will be made with heavy putty consistency as a border molding material and the final impression will be made with light rubber base (3M) impression material, Then Pouring of the final impressions with type 4 Hydrocal dental stone (Hydrocal Dental stone, Bayer, and Germany). Master casts will be optically scanned using 3 shape optical scanner. Duplication of master casts will be done using silicone duplicating material. Titanium and cobalt/chromium metallic bases will be milled using 3shape milling machine to cover the palate with mesh extension over the ridge. They will be tried intra-orally regarding sitting and stability. Occlusal rim will be set on titanium metallic base then face bow record will be recorded then mounting the maxillary master cast. Centric relation will be registered then mounting of the mandibular cast will be done. The same will be done for the duplicate cast with the Cobalt/Chromium metallic base. Then Setting of the anatomical teeth for both master casts then try-in stage will be checked intra-orally then packing of cast and duplicate cast with conventional heat cured acrylic resin (Dentsply, Dentsply limited, Weybridge, Surrey. England) after flasking each denture will be finished.

The dentures will be delivered, then the assessment will be immediately and after 1 week then after 3 months that a hook screw with its nut (Digital force gauge instrument, model 475044) will be secured in the polished mid-palatal surface of the upper denture using metallic adhesive to record the amount of the force required for dislodgment. The pull end of the digital force gauge device will be connected to the hook positioned at maxillary dentures for one type of the two dentures and will be pulled vertically until denture dislodgement occurred, then the patient will take off his first type of denture for 2 weeks as a washout period then the second type of denture will be delivered and the same assessment will be done.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: the participants will not be told which type they received till obtaining the final results of both types.Outcomes will be collected only by the supervisor.
Primary Purpose: Other
Official Title: Retention of Computer Aided Design and Computer Aided Manufacturing Titanium Versus Cobalt/Chromium Maxillary Single Denture Bases: A Randomized Clinical Trial.
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arm Intervention/treatment
Experimental: intervention arm
the group of participants will take the CAD/CAM titanium denture bases and assessment during and after the first 3 months after delivery of the first type.
Device: CAD/CAM titanium denture base
metallic denture base made of titanium

Experimental: intervention arm 2
the same group of participants will take the CAD/CAM cobalt/chromium denture bases and assessment during and after the second 3 months after delivery of the second type.
Device: CAD/CAM cobalt/chromium denture bases
metallic denture bases made of cobalt/chromium




Primary Outcome Measures :
  1. Retention of single denture [ Time Frame: 6.5 months ]
    the dislodgement force of the denture will be assessed



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 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Completely edentulous maxillary arch and fully dentate mandibular arch with adequate interarch space.
  • The edentulous ridges should be covered by firm healthy mucosa.
  • Angle class I maxillomandibular relationship
  • Healthy and co-operative patients.

Exclusion Criteria:

  • Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than I 0 cigarettes/day).
  • Previous history of radiotherapy or chemotherapy.
  • Any skeletal problem dictates surgical intervention.

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): NCT03675594


Contacts
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Contact: Amal el rekaby, professor 0122258794 prosthetic@dentistry.cu.edu.eg
Contact: ahmed saad, lecturer 0118976584 ahmed_saad@dentistry.cu.edu.eg

Locations
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Egypt
Faculty of Oral and Dental Medicine
Cairo, Manyal, Egypt, 12554
Contact: atef shaker, dean    (+202) 23642938    dean@dentistry.cu.edu.eg   
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: iman rady, professor head of evidence based dentistry
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Responsible Party: Amr Gamal Ismail Mohamed, Assistant lecturer of prosthodontics, Cairo University
ClinicalTrials.gov Identifier: NCT03675594    
Other Study ID Numbers: 28912240102212
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: it will not be shared with other researchers except my supervisor

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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
Keywords provided by Amr Gamal Ismail Mohamed, Cairo University:
Dislodgement force
Digital denture
CAD/CAM metallic dentures
Additional relevant MeSH terms:
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Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Cobalt
Chromium
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs