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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06343441
Other study ID # SH9H-2024-T29-2
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 31, 2024
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the accuracy of digital impression and conventional impression for complete-arch implant-supported fixed prosthesis


Description:

The Intraoral scan is digital optical scan method, that has advantages such as being more comfortable, easy to transfer, and full digital workflow. Conventional impression using silicon rubber and gained stable accuracy of impression. This study aims to compare the accuracy of two methods.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 22
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Age 18-70 years old (including 18 and 70 years old); - The patient's maxilla or mandible cannot be preserved due to missing teeth or remaining teeth proposed for implant-retained restoration; - The patient's missing teeth area is available for placement of 4-6 implants; - Completion of osseointegration of the patient's implants after implant surgery; - The patient has at least 2 mm width of keratinized mucosa in the remaining alveolar ridge; - The patient voluntarily participates in the trial and signs an informed consent form Exclusion Criteria: - The patient has a severe gag reflex; - The patient has an intermaxillary distance of less than 20 mm in the posterior region; - The distance between the two implants is less than 10 mm; - Implants fitted with composite abutments with the abutment screw holes penetrating at an angle greater than 60 degrees to the alveolar ridge; - Other patients judged by the investigator to be unsuitable for inclusion

Study Design


Related Conditions & MeSH terms


Intervention

Device:
intraoral scan
intraoral scanning of the edentulous arch and scan body
open tray impression
conventional method of impression making with silicone rubber material

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Outcome

Type Measure Description Time frame Safety issue
Primary Grade of framework passive fit The passive fit of the titanium framework is measured with a scoring system. Five aspects are evaluated. whether to pry; Single Screw Probing misfit; All Screws; Probing misfit; Smooth during screwing; X-ray for misfit. For each aspect, 0/1 is scored. the total score is between 0 and 5. during the deliver of the framework
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