The Accuracy of Conventional Versus Digital Implant Impression Techniques

Missing Teeth Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04908618
• Other study ID #: 256413854
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anodontia
• Missing Teeth
• Tooth Loss

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