NCT03025243

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

January 16, 2017

Last Update Submit

January 16, 2017

Conditions

Guided Surgery

Keywords

computer aided design , dental implants , accuracy

Outcome Measures

Primary Outcomes (1)

  • accuracy of surgical guide

    6 months

Study Arms (2)

50 micron

EXPERIMENTAL

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

Device: computer aided surgical guide

100 micron

ACTIVE COMPARATOR

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

Device: computer aided surgical guide

Interventions

computer aided surgical guideDEVICE

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
100 micron50 micron

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Mahmoud El far, phd

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Amr M Hanafy, master

CONTACT

01111228022amrhanafy201055@yahoo.com

Amr H El-Khadem, phd

CONTACT

01001162401amrelkhadem@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master students

Study Record Dates

First Submitted

January 16, 2017

First Posted

January 19, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

January 19, 2017

Record last verified: 2017-01