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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
Mohamed Mahmoud Dohiem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Missing Teeth

Eligibility Criteria

30 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

First Posted
May 21, 2021
Last Updated
May 26, 2021
Sponsor
Mohamed Mahmoud Dohiem
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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

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The Accuracy of Conventional Versus Digital Implant Impression Techniques

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