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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04908618
Other study ID # 256413854
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 20, 2021
Est. completion date May 22, 2021

Study information

Verified date May 2021
Source Zagazig University
Contact mohamed M DOHIEM, lecturer
Phone 00201002411965
Email mdohiem@zu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 8
Est. completion date May 22, 2021
Est. primary completion date May 21, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 30 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
digital impression for normal abutment
Accuracy of scan body impression
open tray impression
Accuracy of open tray impression
closed tray impression
Accuracy of closed tray impression

Locations

Country Name City State
Egypt Mohamed Mahmoud Dohiem Cairo

Sponsors (1)

Lead Sponsor Collaborator
Mohamed Mahmoud Dohiem

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary total deviation between digital impression and conventional impression 1 day
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