Assessment of the Accuracy of Surgical Guide Designed From Dental Model Optical Scan Versus Impression Inversion With Markers Techniques in Computer Guided Implantology. Randomized Clinical Trial.

December 8, 2017 updated by: Abdullah Ahmed Elmasry, Cairo University

Dental model cast accuracy can be affected by many variables as tray material, impression material and time elapsed before pouring the impression. All these factors would affect the accuracy of the surgical guide

Impression inversion with markers technique avoids the dimension changes that may happen from pouring of the dental model cast. Also it saves time as no need for optical scan of the model cast and for scan appliance even in cases of multiple restoration. Adding markers to impression tray ensures an accurate merge even if the patient has restored dentition that may cause scatter during the CT/CBCT scan.

This study will is for Assessment of the Accuracy of Surgical Guide designed from Dental Model Optical Scan versus Impression Inversion with Markers techniques in Computer Guided Implantology.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • Recruiting
        • Faculty of dentistry , Cairo university
        • Contact:
        • Principal Investigator:
          • Abdullah A Elmasry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Partially Edentulous patients seeking for dental implants
  2. Patients with Bucco-lingual bone thickness more than 6 mm allowing flapless implant placement.
  3. Medically free patients.

    -

    Exclusion Criteria:

1- Patients with thin ridges. 2- Patients with systemic disease that may affect bone quality. 3- Patients with poor oral hygiene and active periodontal diseases. 4- Anatomical situations requiring regenerative procedure. 5- Completely edentulous patient 6-Patient with limited mouth opening

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Accuracy of surgical guide from Model optical scan
Active Comparator: Accuracy of surgical guide from Impression inversion Technique
Rather than using optical scan of the cast , We will use impression inversion technique with VPS impression and adding CBCT Markers on the tray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of angular deviation of virtual implants and actual implant position according to scanning protocol "optical scan of the model" Versus "impression inversion" using CBCT.
Time Frame: Immediate post operative
Immediate post operative

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of linear deviation of virtual implants and actual implant position according to scanning protocol " optical scan of the model" Versus " impression inversion " using CBCT
Time Frame: Immediate post operative
Immediate post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Anticipated)

March 15, 2018

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

December 5, 2017

First Submitted That Met QC Criteria

December 5, 2017

First Posted (Actual)

December 11, 2017

Study Record Updates

Last Update Posted (Actual)

December 12, 2017

Last Update Submitted That Met QC Criteria

December 8, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • SGCBCTELMASRY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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