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

Dental Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04329169
• Other study ID #: Virtual implant planning
• Status: Completed
• Phase: N/A
• Start date: June 28, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: March 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 1, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implants

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Nourhan M.Aly	Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3D- Deviation of the implant	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