Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05919862
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-07
First Post:
2023-06-15
Brief Title:
Accuracy of Dental Implant Placement Using a Collaborative Surgery Robot
Sponsor:
Shanghai Ninth Peoples Hospital Affiliated to Shanghai Jiao Tong University
Organization:
Shanghai Ninth Peoples Hospital Affiliated to Shanghai Jiao Tong University
Study Overview
Official Title:
Three-dimensional Positional Accuracy of Dental Implant Placement Using a Haptic and Machine Vision Controlled Collaborative Surgery Robot a Pilot Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For free hand dental implant placement a key difficulty is to accurately control the position Improving precision of dental implant placement is considered important for safety and efficacy of tooth replacement with dental implants The goal of this randomized controlled trial is to compare the positional implant accuracy and patient reported outcomes comparing two methods of implant placement the use of a robotic assisted surgery and freehand surgery Patients requiring single tooth replacement with a dental implant will be digitally planned using a CBCT and an intraoral digital scan Subjects will be randomized to one of the two treatment modalities based on the plan The accuracy of placement will be assessed evaluating the difference between the planned and the actual position using a CBCT immediately after surgery Subjects will be followed up for one year to assess both patient reported and professional outcomes
Detailed Description:
For free hand dental implant placement a key difficulty is to accurately control the position Improving precision of dental implant placement is considered important for safety and efficacy of tooth replacement with dental implants In particular more precise implant placement is expected to yield a better restoration both in terms of aesthetics and ability for self-performed oral hygiene and thus prevention of peri-implant diseases The goal of this randomized controlled trial is to compare the positional implant accuracy and patient reported outcomes comparing two methods of implant placement the use of a robotic assisted surgery and freehand surgery Patients requiring single tooth replacement with a dental implant will be digitally planned using a CBCT and an intraoral digital scan Subjects will be randomized to one of the two treatment modalities based on the plan The accuracy of placement will be assessed evaluating the difference between the planned and the actual position using a CBCT immediately after surgery Subjects will be followed up for one year to assess both patient reported and professional outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None