Digital Assessment of a Full Digital Implant-Prosthetic Workflow for a Prefabricated Single Implant-Supported Restoration
1 other identifier
interventional
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedFirst Submitted
Initial submission to the registry
March 28, 2020
CompletedFirst Posted
Study publicly available on registry
April 1, 2020
CompletedApril 1, 2020
March 1, 2020
7 months
March 28, 2020
March 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Virtual Implant Planning
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Patients missing lower first molar unilaterally or bilaterally.
- Presence of full or nearly full complement of opposing natural teeth.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nourhan M.Alylead
- Alexandria Universitycollaborator
Study Sites (1)
Faculty of Dentistry, Alexandria University
Alexandria, 21512, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
Muhammed Badee, M.Sc
Faculty of Dentistry, Alexandria University, Egypt
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dental Public Health clinical instructor and study statistician
Study Record Dates
First Submitted
March 28, 2020
First Posted
April 1, 2020
Study Start
June 28, 2019
Primary Completion
January 30, 2020
Study Completion
February 1, 2020
Last Updated
April 1, 2020
Record last verified: 2020-03