The Effect of Printing Layer Thickness on the Accuracy of Computer Aided Surgical Guides

NCT ID: NCT03025243

Last Updated: 2017-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-01-31

Brief Summary

The purpose of this study is to evaluate the effect of printing layer thickness on accuracy of computer aided surgical guide

Detailed Description

Computer aided surgical guide has many variables that affect its accuracy , in this study one variable is considered that may affect the accuracy of surgical guide which is printing of layer thickness of surgical guide whether 50 micron or 100 micron.

computer aided surgical guide is constructed by imaging the patient pre-operative cone beam CT wearing scan appliance , then virtual implant placement on special soft ware ( Blue sky Bio ) and optical scanning of patient casts , afterword superimposition of the virtual implants on the scanned casts to design the surgical guide and printing on 3D printer ( Zenith 3D printer , Dentis , Korea ) with printing layer thickness 50 micron in first group and 100 micron in second group . Fixation of surgical guide in patient mouth and drilling of implant osteotomy through the guiding sleeves , post-operative Cone Beam CT with the same apparatus and setting as pre-operative scan .

Finally, the pre-operative and post operative scans were then overlapped to measure linear and angular deviation of the virtually planned and actual implants position.

Conditions

Guided Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

50 micron

surgical guide constructed with 3D printing with printing layer thickness 50 micron

Group Type: EXPERIMENTAL

computer aided surgical guide

Intervention Type: DEVICE

comparing accuracy of surgical guide of printing layer thickness of 50 micron and 100 micron by superimposition of pre-operative and post-operative CBCT

100 micron

surgical guide constructed with 3D printing with printing layer thickness 100 micron

Group Type: ACTIVE_COMPARATOR

computer aided surgical guide

Intervention Type: DEVICE

comparing accuracy of surgical guide of printing layer thickness of 50 micron and 100 micron by superimposition of pre-operative and post-operative CBCT

Interventions

computer aided surgical guide

comparing accuracy of surgical guide of printing layer thickness of 50 micron and 100 micron by superimposition of pre-operative and post-operative CBCT

Intervention Type: DEVICE

Other Intervention Names

surgical guide

Eligibility Criteria

Inclusion Criteria

• patients partially or totally edentulous arches .
• patients with Bucco-lingual bone thickness >6 mm allowing flapless implant placement
• patients free from any systemic diseases that may affect bone quality e.g diabetes .

Exclusion Criteria

• patients with thin ridges.
• patients with systemic disease that may affect bone quality.
• Patients with poor oral hygiene and active periodontal diseases.
• Anatomical situations requiring regenerative procedure.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amr Mohamed Ahmed Hanafy

Master students

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahmoud El far, phd

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

Amr M Hanafy, master

Role: CONTACT

amrhanafy201055@yahoo.com

01111228022

Amr H El-Khadem, phd

Role: CONTACT

amrelkhadem@gmail.com

01001162401

Other Identifiers

CEBC-CU-2017-01-08

Identifier Type: -

Identifier Source: org_study_id