Edentulous JawNCT04627649
Accuracy of Digital Implant Impression
An observational study of Edentulous Jaw, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study aims to investigate the accuracy of complete-arch digital implant impression using newly designed scan bodies with extensional structure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Edentulous Jaw
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Dec 2020to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 15 patients are anticipated.
Who may be able to join
- 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
Who cannot join
- Poor oral hygiene
- Presence of peri-implantitis or peri-implant mucositis
- Presence of temporamandibular joint disease
- Unwilling to paticipate in the research
Trial locations and contacts
1 site in 1 country.
China1 site
Guanghua school of stomatology, hospital of stomtology, Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
Official title: 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.
Read the 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.
- Conditions
- Edentulous Jaw
- Keywords
- dental implant, digital impression, scan body, accuracy
- Medical subject headings
- Jaw, Edentulous
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy
the accuracy is evaluated by comparing the test scans with the reference scan
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study startDec 2020 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Edentulous JawStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuofan Chen, Sun Yat-sen University
- Investigators
- Zhuofan Chen, DDS, Study director, Guanghua School of Stomatology, Hospital of Stomatology, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627649
- Sponsor's protocol ID
- RuoxuanHuang
- Status last verified
- Nov 2020
- First submitted
- 19 Oct 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32166793Mizumoto 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.
PubMed 31040026
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Complete-arch Digital Implant Impression With Newly Designed Scan Bodies
- ClinicalTrials.gov ID
- NCT04627649
- Acronym / sponsor ID
- RuoxuanHuang
- Conditions
- Edentulous Jaw
- Keywords
- dental implant, digital impression, scan body, accuracy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the accuracy of complete-arch digital implant impression using newly designed scan bodies with extensional structure.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 15 patients are anticipated.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Poor oral hygiene
- Presence of peri-implantitis or peri-implant mucositis
- Presence of temporamandibular joint disease
- Unwilling to paticipate in the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
accuracy
Time frame: 0 day
the accuracy is evaluated by comparing the test scans with the reference scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Background: PubMed 32166793Chochlidakis 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.
- Background: PubMed 31040026Mizumoto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhuofan Chen, DDS study director
Guanghua School of Stomatology, Hospital of Stomatology, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edentulous Jaw, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruoxuan Huang, MDS (86-18819472978, huangrx3@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy (time frame: 0 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04627649, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.