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Maxillary Sinus Floor Elevation Using DENSAH Burs Versus Summers Osteotomes

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ClinicalTrials.gov Identifier: NCT03732885
Recruitment Status : Unknown
Verified November 2018 by Sohaib Mohamed Alzamzamy Mohamed Elsheikh, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Sohaib Mohamed Alzamzamy Mohamed Elsheikh, Cairo University

Study Description
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Brief Summary:
To investigate the efficacy of osseodensification drills (Densah bure) as a new closed sinus lift tool and to compare the effect of it in bone gaine versus traditional osteotomes.

Condition or disease Intervention/treatment Phase
Implant Tissue Failure Device: densah burs osseo densification drills Device: Summer's Osteotomes Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Crestal Maxillary Sinus Floor Elevation Using Osseodensification Drills (Densah Burs) Versus Summers Osteotomes
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : April 15, 2019
Estimated Study Completion Date : July 15, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: densah burs drilling group
maxillary sinus floor elevation during implant placement using Densah burs
 Device: densah burs osseo densification drills
maxillary sinus floor elevation during implant placement using Densah burs
Experimental: Summers osteotomes
maxillary sinus floor elevation during implant placement using Summer's Osteotomes
 Device: Summer's Osteotomes
maxillary sinus floor elevation during implant placement using Summer's Osteotomes


Outcome Measures
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Primary Outcome Measures :
  1. implant stability [ Time Frame: 6 months after surgery ]
    measurement of implant stability using the Ostell


Secondary Outcome Measures :
  1. bone gain [ Time Frame: 6 months after surgery ]
    measurement of bone gain around implant using cone-beam computed tomography CBCT


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with partially edentulous in the posterior area of the maxilla, with a residual ridge that allowed insertion of ≤8 mm length implants.
  • both sexes.
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placement.

Exclusion Criteria:

  • Sinus pathology.
  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems.
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
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): NCT03732885


Contacts
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Contact: Sohaib M Elsheikh, masters 00201222500517 ext 0 alzamzamy44@hotmail.com

Locations
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Egypt
Sohaib M Elsheikh
Cairo, Egypt, 11311
Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Sohaib Mohamed Alzamzamy Mohamed Elsheikh, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03732885    
Other Study ID Numbers: NCT035
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sohaib Mohamed Alzamzamy Mohamed Elsheikh, Cairo University:
Sinus
Stability
Bone gain
Osseodensification