Digital Assessment of a Full Digital Implant-Prosthetic Workflow for a Prefabricated Single Implant-Supported Restoration

March 28, 2020 updated by: Nourhan M.Aly

Digital Assessment of a Full Digital Implant-Prosthetic Workflow for a Prefabricated Single Implant-Supported Restoration (A Clinical Trial)

The aim of the present study was to evaluate the accuracy of a prefabricated digitally planned provisional restoration on a single- implant placed with a fully guided surgical protocol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fifteen dental implants were placed in partially edentulous patients with single bounded lower posterior edentulous area selected from those admitted to the Prosthodontics Department, Faculty of Dentistry, Alexandria University. A full digital implant-prosthetic protocol was followed and a quantitative evaluation of the accuracy of the protocol was performed using computer software and superimposition of the planned and post-operative images was done.

Study Type

Interventional

Enrollment (Actual)

15

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

  • Egypt
      • Alexandria, Egypt, 21512
        • Faculty of Dentistry, Alexandria University

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

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients missing lower first molar unilaterally or bilaterally.
  • Presence of full or nearly full complement of opposing natural teeth.

Exclusion Criteria:

  • If teeth adjacent to the planned implant site showed infections, endodontic or periodontal problems.
  • Patients with a debilitating systemic disease, bone diseases, radiotherapy or chemotherapy.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Virtual Implant Planning
Other: Virtual Implant Planning
According to the virtual implant plan, a CAD/CAM tooth supported surgical guide will be fabricated to place the dental implant with a fully guided surgical protocol.The surgical guide will be manufactured from a photopolymer resin using a 3D printing machine. A hex- shaped metal sleeve will be inserted in the surgical guide with the flat surface located buccally so that it will help in orientation of the implant hex during the implant placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3D- Deviation of the implant
Time Frame: 3 months
The 3D deviation will be calculated by a software taking into consideration the deviation on each direction set as follows: x= buccolingual error, y= mesiodistal error, and z= apicocoronal error, using Pythagorean Theorem: 3D deviation= square root of (x squared + y squared + z squared)
3 months

Collaborators and Investigators

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

Sponsor

Nourhan M.Aly

Collaborators

Alexandria University

Investigators

  • Principal Investigator: Mariam Bahgat, M.Sc, Faculty of Dentistry, Alexandria University, Egypt
  • Principal Investigator: Haitham Ismail, M.Sc, Faculty of Dentistry, Alexandria University, Egypt
  • Principal Investigator: Yassmin Tahamawy, M.Sc, Faculty of Dentistry, Alexandria University, Egypt
  • Principal Investigator: Naema Ammar, M.Sc, Faculty of Dentistry, Alexandria University, Egypt

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)

June 28, 2019

Primary Completion (ACTUAL)

January 30, 2020

Study Completion (ACTUAL)

February 1, 2020

Study Registration Dates

First Submitted

March 28, 2020

First Submitted That Met QC Criteria

March 28, 2020

First Posted (ACTUAL)

April 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 1, 2020

Last Update Submitted That Met QC Criteria

March 28, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Virtual implant planning

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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