Accuracy of Digital Implant Impression | NCT04627649

Studies
Accuracy of Digital Implant Impression

NCT04627649

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Nov 13, 2020Actual

Enrollment

15Estimated

Phase

Not provided

Conditions

Edentulous Jaw

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2020Estimated

Primary Completion Date

Feb 2021Estimated

Completion Date

Feb 2021Estimated

First Submitted Date

Oct 19, 2020

First Submission Date that Met QC Criteria

Nov 8, 2020

First Posted Date

Nov 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2020

Last Update Posted Date

Nov 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
accuracy	the accuracy is evaluated by comparing the test scans with the reference scan	0 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

15 patients are anticipated.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ruoxuan Huang, MDS	Contact	86-18819472978		huangrx3@mail2.sysu.edu.cn
Zhipeng Li, DDS	Contact	86-15920395261		implants@163.com

Overall Officials

Name	Affiliation	Role
Zhuofan Chen, DDS	Guanghua School of Stomatology, Hospital of Stomatology, Sun Yat-sen University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guanghua school of stomatology, hospital of stomtology, Sun Yat-sen University		Guangzhou	Guangdong	510000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32166793	Background	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.
31040026	Background	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.

ID	Term
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases
D009057	Stomatognathic Diseases
D009066	Mouth, Edentulous