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Ball and Socket Versus Locator Attachment Retained Implant Overdentures

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ClinicalTrials.gov Identifier: NCT03930862
Recruitment Status : Unknown
Verified April 2019 by Lamees Hosam Ramadan, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Lamees Hosam Ramadan, Cairo University

Study Description
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Brief Summary:
Will the use of locator attachment influence the muscle efficacy when compared to ball and socket attachment in mandibular implant overdenture? '

Condition or disease Intervention/treatment Phase
Complete Edentulism Device: Locator Attachment (positioner) Not Applicable

Detailed Description:
In this study we will use a two different types of attachments in implants overdenture in mandibular completely edentulous patients to increase the retention and stability of the denture and this can be recognized by record the masticatory function of the muscles of the mandibular jaw.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Muscle Activity and Patients Satisfaction on Implants Supported Overdenture Using Ball and Socket Versus Locator Attachment
Estimated Study Start Date : September 15, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ball and socket
It is an attachment retaining implant overdentures to increase retention and stability of the denture
 Device: Locator Attachment (positioner)
intra oral attachment
Experimental: Locator attachment
attachment retaining implant overdentures
 Device: Locator Attachment (positioner)
intra oral attachment


Outcome Measures
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Primary Outcome Measures :
  1. Muscle Activity [ Time Frame: 6 month ]
    Digital Electromyogram


Secondary Outcome Measures :
  1. Patient Satisfaction: questionnaire [ Time Frame: 6 month ]
    questionnaire from zero to 10 where zero is completely unsatisfied and 10 is highly satisfied


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:   No
Criteria

Inclusion Criteria:

- Upper and lower completely edentulous patients. Acceptance of the existing denture if it is good, or constructing a new one if it is defected.

Patients with adequate bone quality and quantity. Tooth extracted not less than 6 month.

Exclusion Criteria:

  1. Young patients.
  2. Diseases affecting neuromuscular coordination.
  3. TMJ diseases.
  4. Soft tissue abnormalities.
  5. Bony exostosis.
  6. Parathyroid dysfunction
  7. uncontrolled Diabetes
  8. Radiotherapy to the neck or head
  9. Pregnancy.
  10. Drug and alcohol dependency.
  11. Smokers.
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): NCT03930862


Contacts
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Contact: Lamees Hosame, Master 020-1020111367 Lamees_bota@hotmail.com

Sponsors and Collaborators
Lamees Hosam Ramadan
Investigators
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Study Director: Nada Sherine, PhD Lecturer of Prosthdontics
More Information
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Responsible Party: Lamees Hosam Ramadan, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03930862    
Other Study ID Numbers: Muscle activity
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
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