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Bone Changes Assessment in Screw-Retained Maxillary Complete Denture With Electric Welded Framework Versus Cast One

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ClinicalTrials.gov Identifier: NCT04548258
Recruitment Status : Unknown
Verified October 2020 by Shaimaa Magdy Abd Elhakm Mohmed, Cairo University.
Recruitment status was:  Recruiting
First Posted : September 14, 2020
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Shaimaa Magdy Abd Elhakm Mohmed, Cairo University

Study Description
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Brief Summary:
comparing bony changes around implants that will be joined by ametal framework either with electric weiling or with the conventional casting metal

Condition or disease Intervention/treatment Phase
Bone Resorption Device: electric intraoral weilding Device: casting Not Applicable

Detailed Description:
joining multiple implants together in the edentulous arches is considered agood solution, using the conventional casting technique has many disadvantages due to lab errors and time and cost consuming on ,the other hand the study aims to owercome these disadvantages using electric welding metal framework.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bone Changes Assessment in Screw-Retained Maxillary Implant Supported Complete Denture With Electric Welded Metal Framework Versus Cast One (Randomized Control,Split Mouth Trial)
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arms and Interventions
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Arm Intervention/treatment
Experimental: electric welded metal framework
using electric welding device to intraorally join metal framework where the study aim to save time and cost and eliminate lab errors
 Device: electric intraoral weilding
weilding metal framework to the implants in completely edentulous maxilla using electric weilding device intraorally
Experimental: conventional cast metal technique
using the conventional casting technique to join metal framework and compare it with the electric welding technique
 Device: casting
casting metal framework


Outcome Measures
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Primary Outcome Measures :
  1. bony changes assessment [ Time Frame: 12 months ]
    assessment of bone height changes around implants using digital periapical paralling imaging technique and the unit will be meagured in mm.


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age range from 30 to 65 years old.
  • Absence of any medical disorder that could complicate the Surgical phase or affect osseointegration.
  • The patients must be completely edentulous.
  • The patient must have enough bone height for implants minimum length of 10mm and a minimum diameter of 5 mm.
  • Patients with good oral hygiene.
  • Complete denture wearer.
  • Adequate inter arch space for screw retained prosthesis.
  • Absence of any intra-oral pathological condition.

Exclusion Criteria:

Patients with recent extraction(less than three months).

  • Patients with inflamed ridge or candida infection.
  • Patients with flappyridge.
  • Parafunctional habits.
Contacts and Locations
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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): NCT04548258


Contacts
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Contact: faculty of dentistry cairo university 0235676105 ext +2 dentmail@dentistry.cu.edu.eg

Locations
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Egypt
Cairo University ,Faculty of Dentistry Recruiting
Cairo, Egypt, 11553
Contact: faculty of dentistry cairo dentistry         
Contact: cairo university faculty of dentistry         
Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Shaimaa Magdy Abd Elhakm Mohmed, principle investigator, Cairo University
ClinicalTrials.gov Identifier: NCT04548258    
Other Study ID Numbers: 6420
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bone Resorption
Bone Diseases
Musculoskeletal Diseases