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Assesment of the Accuracy of Surgical Guide Designed From CBCT With Different Voxel Sizes

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ClinicalTrials.gov Identifier: NCT03389594
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Accuracy Of CBCT affected by many factors. On of the most factors the affect the image quality is voxel size. Larger voxel size give a higher accuracy of the images but with higher radiation dose.

The study is to assist the accuracy of surgical guides designed from CBCT with different voxel sizes .


Condition or disease Intervention/treatment
Accuracy of Surgical Guide in Implants Other: Surgical guide

Detailed Description:

Accuracy Of CBCT affected by many factors. On of the most factors the affect the image quality is voxel size. Larger voxel size give a higher accuracy of the images but with higher radiation dose.

The study is to assist the accuracy of surgical guides designed from CBCT with different voxel sizes (voxel size 0.4mm & 0.2mm)


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Each patient will be given a code by researcher (M.H) and the observers will be blind to which group this case belong
Primary Purpose: Other
Official Title: Assesment of the Accuracy of Surgical Guide Designed From CBCT With Different Voxel Size in Computer Guided Implantology Randomized Clinical Trial
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : March 15, 2018
Estimated Study Completion Date : April 1, 2018
Arms and Interventions

Arm Intervention/treatment
No Intervention: Surgical guide designed from voxel size 0.2mm
Surgical guide will be designed based on CBCT voxel size 0.2mm
Active Comparator: Surgical guide designed from voxel size 0.4m
Surgical guide will be designed based on CBCT voxel size 0.4 mm
Other: Surgical guide
Surgical Guide for this group will designed from 0.4mm voxel size


Outcome Measures

Primary Outcome Measures :
  1. Angular deviation [ Time Frame: Immediate post operative ]
    Evaluation of angular deviation of virtual implant and actual implant positions according to voxel size difference (0.2 mm versus 0.4 mm)

  2. Linear deviation [ Time Frame: Immediate post operative ]
    Evaluation of linear deviation of virtual implant and actual implant positions according to voxel size difference (0.2 mm versus 0.4 mm


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • partially edentulous patients seeking for dental implant
  • Bucco-lingual width more than 6 mm
  • Medically free patients

Exclusion Criteria:

  • patients with thin ridges that may need augmentation
  • patients with systematic diseases that may affect bone quality
  • completely edentulous patients
  • patients with limited mouth opening
Contacts and Locations

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): NCT03389594


Contacts
Contact: Mohamed Elhag, Bachelorie (+202) 23634965 ext 202 dentmail@dentistry.cu.edu.eg

Locations
Egypt
Cairo University Recruiting
Cairo, Egypt, 02
Contact: Info@dentistry.cu.edu.eg    0223634965    Info@dentistry.cu.edu.eg   
Principal Investigator: Mohammed Elhag         
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Cairo university Cairo University, Faculty of dentistry
More Information

Responsible Party: Mohammed Mohammed Ahmed Elhag, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03389594     History of Changes
Other Study ID Numbers: ElhagCUImplant
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Mohammed Mohammed Ahmed Elhag, Cairo University:
Surgical guide
Computer guided implantology
CBCT voxel size