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Custom-made Ceramic Barrier vs Titanium Mesh

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ClinicalTrials.gov Identifier: NCT03734094
Recruitment Status : Completed
First Posted : November 7, 2018
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed El Saharty, Cairo University

Study Description
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Brief Summary:
It is a comparative study between custom-made ceramic barrier and titanium mesh for augmentation of atrophic posterior mandible.

Condition or disease Intervention/treatment Phase
Bone Loss Device: Ceramic barrier Device: Titanium Mesh Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparative Study Between Custom-made Ceramic Barrier and Titanium Mesh for Augmentation of Atrophic Posterior Mandible
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 1, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Ceramic Barrier
The use of a ceramic barrier to induce bone formation during GBR
 Device: Titanium Mesh
The use of a titanium mesh to induce bone formation during GBR
Active Comparator: Titanium mesh
The use of a titanium mesh to induce bone formation during GBR
 Device: Ceramic barrier
The use of a ceramic barrier to induce bone formation during GBR


Outcome Measures
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Primary Outcome Measures :
  1. Bone height [ Time Frame: 6 months ]
    CBCT & Three dimensional planning software to measure the height of bone gained in millimeters.

  2. Bone width [ Time Frame: 6 months ]
    CBCT & Three dimensional planning software to measure the width of bone gained in millimeters.


Secondary Outcome Measures :
  1. Histomorphometric - bone area percent [ Time Frame: 6 months ]
    Histomorphometric analysis of bone area percent


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with atrophic posterior mandible
  • Both sexes
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placement

Exclusion Criteria:

  • Untreated gingivitis
  • Periodontitis
  • Insufficient oral hygiene
  • Previous radiation therapy
  • Head and neck neoplasia
  • Systemic disorders
  • Heavy smokers
  • Bone pathology
  • Psychiatric problems
  • Emotional instability
  • Unrealistic aesthetic demands
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): NCT03734094


Locations
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Egypt
Cairo University
Cairo, Egypt, 12611
Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Mohamed El Saharty, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03734094    
Other Study ID Numbers: 737
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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