- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04627649
Accuracy of Digital Implant Impression
November 8, 2020 updated by: Zhuofan Chen, Sun Yat-sen University
Accuracy of Complete-arch Digital Implant Impression With Newly Designed Scan Bodies
This study aims to investigate the accuracy of complete-arch digital implant impression using newly designed scan bodies with extensional structure.
Study Overview
Status
Unknown
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ruoxuan Huang, MDS
- Phone Number: 86-18819472978
- Email: huangrx3@mail2.sysu.edu.cn
Study Contact Backup
- Name: Zhipeng Li, DDS
- Phone Number: 86-15920395261
- Email: implants@163.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Guanghua school of stomatology, hospital of stomtology, Sun Yat-sen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
15 patients are anticipated.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
accuracy
Time Frame: 0 day
|
the accuracy is evaluated by comparing the test scans with the reference scan
|
0 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Zhuofan Chen, DDS, Guanghua School of Stomatology, Hospital of Stomatology, Sun Yat-sen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2020
Primary Completion (Anticipated)
February 1, 2021
Study Completion (Anticipated)
February 1, 2021
Study Registration Dates
First Submitted
October 19, 2020
First Submitted That Met QC Criteria
November 8, 2020
First Posted (Actual)
November 13, 2020
Study Record Updates
Last Update Posted (Actual)
November 13, 2020
Last Update Submitted That Met QC Criteria
November 8, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RuoxuanHuang
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Edentulous Jaw
-
Dentsply Sirona Implants and ConsumablesCompletedPartially Edentulous JawChina
-
University of Alabama at BirminghamZimmer DentalCompleted
-
Dentsply Sirona Implants and ConsumablesCompletedPartially Edentulous JawChina
-
Dentsply Sirona Implants and ConsumablesCompletedPartially Edentulous JawChina
-
Dentsply Sirona Implants and ConsumablesCompleted
-
Dentsply Sirona Implants and ConsumablesCompleted
-
University of IowaEnrolling by invitationEdentulous Jaw | Edentulous MouthUnited States
-
Concordia Dent SrlITI International Team for Implantology, SwitzerlandCompletedMANDIBLE | ATROPHYC EDENTULOUS JAWRomania
-
University of Roma La SapienzaCompletedEdentulous Patients
-
Cairo UniversityUnknownEdentulous Alveolar Ridge | Edentulous Jaw | Edentulous MouthEgypt