CClinicalTrials.gg
Status unknownNCT03025243Updated Jan 19, 2017

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

An interventional study of computer aided surgical guide in Guided Surgery, sponsored by Cairo University. Status unknown. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-19.

Sponsored by Cairo University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Guided Surgery

Keywords

  • computer aided design , dental implants , accuracy
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    50 micron

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

    Device: computer aided surgical guide

  • Active comparator
    100 micron

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

    Device: computer aided surgical guide

Interventions

  • Devicecomputer 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

    Also known as: surgical guide

06

What researchers measure

Primary outcomes

  1. accuracy of surgical guide

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03025243
Lead sponsor
Cairo University
Responsible party
Amr Mohamed Ahmed Hanafy (Master students, Cairo University) — Principal investigator
First posted
Jan 19, 2017
Start date
Jan 2017
Primary completion
Jan 2018 (estimated)
Completion
Jan 2018 (estimated)
Last update
Jan 19, 2017

Study contacts

Amr M Hanafy, master
Contact
amrhanafy201055@yahoo.com
01111228022
Amr H El-Khadem, phd
Contact
amrelkhadem@gmail.com
01001162401
Mahmoud El far, phd
study director · Cairo University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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