NCT03389594

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 .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

July 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2018

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

January 3, 2018

Status Verified

December 1, 2017

Enrollment Period

9 months

First QC Date

December 13, 2017

Last Update Submit

January 2, 2018

Conditions

Accuracy of Surgical Guide in Implants

Keywords

Surgical guideComputer guided implantologyCBCT voxel size

Outcome Measures

Primary Outcomes (2)

  • Angular deviation

    Evaluation of angular deviation of virtual implant and actual implant positions according to voxel size difference (0.2 mm versus 0.4 mm)

    Immediate post operative

  • Linear deviation

    Evaluation of linear deviation of virtual implant and actual implant positions according to voxel size difference (0.2 mm versus 0.4 mm

    Immediate post operative

Study Arms (2)

Surgical guide designed from voxel size 0.2mm

NO INTERVENTION

Surgical guide will be designed based on CBCT voxel size 0.2mm

Surgical guide designed from voxel size 0.4m

ACTIVE COMPARATOR

Surgical guide will be designed based on CBCT voxel size 0.4 mm

Other: Surgical guide

Interventions

Surgical guideOTHER

Surgical Guide for this group will designed from 0.4mm voxel size

Surgical guide designed from voxel size 0.4m

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 02, Egypt

RECRUITING

Study Officials

  • Cairo university

    Cairo University, Faculty of dentistry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Elhag, Bachelorie

CONTACT

(+202) 23634965dentmail@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Each patient will be given a code by researcher (M.H) and the observers will be blind to which group this case belong
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 13, 2017

First Posted

January 3, 2018

Study Start

July 1, 2017

Primary Completion

March 15, 2018

Study Completion

April 1, 2018

Last Updated

January 3, 2018

Record last verified: 2017-12

Locations

EG(1)