- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04908618
The Accuracy of Conventional Versus Digital Implant Impression Techniques
May 26, 2021 updated by: Mohamed Mahmoud Dohiem
Comparing the Accuracy of Intraoral Scanning of Ready Made Abutments Versus Intraoral Scan Bodies, Digitized Conventional Open and Closed Tray Implant Impression Techniques. A Controlled Clinical Trial
Intraoral oral scanning significantly improves scanning accuracy compared to digitized conventional impression techniques.
The digitized closed tray impression technique showed significantly more accurate results than the digitized open-tray impression technique in partially edentulous patients.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The study was a controlled clinical trial using cone-beam computed tomography (CBCT) imaging and flapless surgical technique to place implants.
Cone-beam Computed Topography of the patients was taken by x-ray machine to create a DICOM file of the patient.
Intraoral scanning to create STL Files of the patient arches.
Each patient had undergone four impression techniques: Conventional impression I; Closed tray impression technique, Conventional impression II; Splinted Open tray impression technique, Digital impression I; intraoral scanning of readymade abutments and Digital impression II; intraoral scanning using scan bodies.
To digitize the Conventional impressions I and II, the readymade abutment was screwed on the analogs of the resultant stone casts, followed by digital scanning.
Using the scan body, the exact implant position was determined and the implants were added using a digital library.
The custom abutment was fabricated on the implant replica with the same readymade abutment measurement.
Using the inspection software, a custom abutment was superimposed on each readymade abutment in all the readymade abutment scanning data with the best-fit algorithm.
Then the custom abutment was saved as a new STL file for comparison.
The digital impression I was set as a reference in all the coming comparisons.
The comparison was done from different data acquisition techniques by using inspection software between Digital impression I, Digital impression II; and finally, with the digitized STL of the Conventional impressions I and II.
Study Type
Interventional
Enrollment (Anticipated)
8
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 Contact
- Name: mohamed M DOHIEM, lecturer
- Phone Number: 00201002411965
- Email: mdohiem@zu.edu.eg
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Mohamed Mahmoud Dohiem
-
Contact:
- mohamed mahmoud, lecturer
- Phone Number: 01002411965
- Email: mdohiem@zu.edu.eg
-
-
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
30 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
Partial edentulous patients
- Sufficient bone volume to insert implants
- Age ranging from 30-50.
- Good oral hygiene.
- Intact hard and soft tissues, including treated teeth decay and healed teeth extraction socket
Exclusion Criteria:
• Completely edentulous patients
- Patients with Bruxism or clinching
- need for bone augmentation,
- uncompensated diabetes mellitus,
- immunocompromised status, radio- and/or chemotherapy
- previous treatment with oral and/or intravenous aminobisphosphonates.
- Undergoing orthodontic treatment;
- Patients with metal crowns and any other metal materials on teeth
- Patients with soft tissue lesions and postoperative scars on the palate
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: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: digital impression with normal abutment for dental implant
digital impression using a ready-made abutment for dental implant
|
Accuracy of scan body impression
Accuracy of open tray impression
Accuracy of closed tray impression
|
Experimental: digital impression with scan abutment for dental implant
digital impression with scan body abutment for dental implant
|
Accuracy of scan body impression
Accuracy of open tray impression
Accuracy of closed tray impression
|
Experimental: open tray conventional dental implant impression
Digitized open tray dental implant impression
|
Accuracy of scan body impression
Accuracy of open tray impression
Accuracy of closed tray impression
|
Experimental: closed tray impression for dental implant
Digitized closed tray dental implant impression
|
Accuracy of scan body impression
Accuracy of open tray impression
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
total deviation between digital impression and conventional impression
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 20, 2021
Primary Completion (Actual)
May 21, 2021
Study Completion (Anticipated)
May 22, 2021
Study Registration Dates
First Submitted
May 21, 2021
First Submitted That Met QC Criteria
May 26, 2021
First Posted (Actual)
June 1, 2021
Study Record Updates
Last Update Posted (Actual)
June 1, 2021
Last Update Submitted That Met QC Criteria
May 26, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 256413854
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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