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NCT04627649 Clinical Trial

Accuracy of Digital Implant Impression

Edentulous Jaw Clinical Trial

Official title:
Accuracy of Complete-arch Digital Implant Impression With Newly Designed Scan Bodies

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04627649
Other study ID # RuoxuanHuang
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2020
Est. completion date February 2021

Study information
Verified date November 2020
Source Sun Yat-sen University
Contact Ruoxuan Huang, MDS
Phone 86-18819472978
Email huangrx3@mail2.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to investigate the accuracy of complete-arch digital implant impression using newly designed scan bodies with extensional structure.

Description:

Fully edentulous patients with 2-6 dental implants are included in this study. For each patient, the follow three impressions are made: conventional splinted open-tray impression, digital impression using scan bodies without extensional structure, and digital impression using scan bodies with extensional structure. The accuracy of the three impressions is compared in an inspection software.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 15
Est. completion date February 2021
Est. primary completion date February 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - At least 18 years old and able to understand an informed consent - Fully edentulous jaw - 2-6 dental implants have been placed in the edentulous jaw - The implants have been osseointegrated - Mouth opening larger than 4.5 cm Exclusion Criteria: - Poor oral hygiene - Presence of peri-implantitis or peri-implant mucositis - Presence of temporamandibular joint disease - Unwilling to paticipate in the research

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Guanghua school of stomatology, hospital of stomtology, Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

Chochlidakis K, Papaspyridakos P, Tsigarida A, Romeo D, Chen YW, Natto Z, Ercoli C. Digital Versus Conventional Full-Arch Implant Impressions: A Prospective Study on 16 Edentulous Maxillae. J Prosthodont. 2020 Apr;29(4):281-286. doi: 10.1111/jopr.13162. Epub 2020 Mar 24. — View Citation

Mizumoto RM, Yilmaz B, McGlumphy EA Jr, Seidt J, Johnston WM. Accuracy of different digital scanning techniques and scan bodies for complete-arch implant-supported prostheses. J Prosthet Dent. 2020 Jan;123(1):96-104. doi: 10.1016/j.prosdent.2019.01.003. Epub 2019 Apr 27. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary accuracy the accuracy is evaluated by comparing the test scans with the reference scan 0 day
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