The Accuracy of Conventional Versus Digital Implant Impression Techniques
Primary Purpose
Missing Teeth
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
digital impression for normal abutment
open tray impression
closed tray impression
Sponsored by
About this trial
This is an interventional treatment trial for Missing Teeth
Eligibility Criteria
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
Sites / Locations
- Mohamed Mahmoud DohiemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
digital impression with normal abutment for dental implant
digital impression with scan abutment for dental implant
open tray conventional dental implant impression
closed tray impression for dental implant
Arm Description
digital impression using a ready-made abutment for dental implant
digital impression with scan body abutment for dental implant
Digitized open tray dental implant impression
Digitized closed tray dental implant impression
Outcomes
Primary Outcome Measures
total deviation between digital impression and conventional impression
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04908618
Brief Title
The Accuracy of Conventional Versus Digital Implant Impression Techniques
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
May 21, 2021 (Actual)
Study Completion Date
May 22, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed Mahmoud Dohiem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
control clinical trial
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
digital impression with normal abutment for dental implant
Arm Type
Active Comparator
Arm Description
digital impression using a ready-made abutment for dental implant
Arm Title
digital impression with scan abutment for dental implant
Arm Type
Experimental
Arm Description
digital impression with scan body abutment for dental implant
Arm Title
open tray conventional dental implant impression
Arm Type
Experimental
Arm Description
Digitized open tray dental implant impression
Arm Title
closed tray impression for dental implant
Arm Type
Experimental
Arm Description
Digitized closed tray dental implant impression
Intervention Type
Other
Intervention Name(s)
digital impression for normal abutment
Intervention Description
Accuracy of scan body impression
Intervention Type
Other
Intervention Name(s)
open tray impression
Intervention Description
Accuracy of open tray impression
Intervention Type
Other
Intervention Name(s)
closed tray impression
Intervention Description
Accuracy of closed tray impression
Primary Outcome Measure Information:
Title
total deviation between digital impression and conventional impression
Time Frame
1 day
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed M DOHIEM, lecturer
Phone
00201002411965
Email
mdohiem@zu.edu.eg
Facility Information:
Facility Name
Mohamed Mahmoud Dohiem
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed mahmoud, lecturer
Phone
01002411965
Email
mdohiem@zu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
The Accuracy of Conventional Versus Digital Implant Impression Techniques
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