Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06349421
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-03-31
Brief Title:
Exploring the Impact of Fully Guided Implant Placement on Classifying Bone Quality Through Tactile Sensation
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Exploring the Impact of Fully Guided Implant Placement on Classifying Bone Quality Through Tactile Sensation
Status:
RECRUITING
Status Verified Date:
2024-03
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:
Bone quality stands as a crucial determinant impacting the success rate of dental implants exerting influence on both implant primary stability and the efficacy of osseointegration While radiographic images can partially reveal bone quality experienced surgeons often rely on tactile sensation during bone drilling to assess it Subsequently based on the diagnosed bone quality distinct implant designs and surgical protocols have been invented to enhance survival rates
Technological advancements now enable the preoperative design of implant placement through a comprehensive guide merging CBCT DICOM files with digital oral scanning data This fully guided approach enhances the precision stability and safety of implant placement surgery However the use of a fully guided surgical guide introduces an additional factor-the friction between the drill and guide-potentially impacting the surgeons tactile feedback
This study aims to assess the difference in bone quality evaluation by tactile sensation between freehand drilling and drilling with a fully guided surgical guide using test blocks of different bone density The discussion will explore the pros and cons of employing a fully guided guide to optimize outcomes in implant treatment
Technological advancements now enable the preoperative design of implant placement through a comprehensive guide merging CBCT DICOM files with digital oral scanning data This fully guided approach enhances the precision stability and safety of implant placement surgery However the use of a fully guided surgical guide introduces an additional factor-the friction between the drill and guide-potentially impacting the surgeons tactile feedback
This study aims to assess the difference in bone quality evaluation by tactile sensation between freehand drilling and drilling with a fully guided surgical guide using test blocks of different bone density The discussion will explore the pros and cons of employing a fully guided guide to optimize outcomes in implant treatment
Detailed Description:
The pilot study involves five subjects while the main experiment will include thirty subjects The experiment consists of two rounds each with seven simulated bone samples These samples include four different densities 5pcf 5pcf 10pcf 10pcf 15pcf 15pcf 30pcf tested in random order Before each round of testing participants drill into a 50 pcf bone sample and identifying it as the hardest scale The experiment then commences with the first round employing conventional drilling tests followed by the second round drilling with a fully guided surgical template After each drilling session participants assess the hardness by recording a VAS score on a 10cm scale The evaluation criteria utilize VAS scores as the measurement tool The aim of this experiment is to investigate whether there are differences in the classification of bone density judged by using a fully guided surgical template compared to judgments made without using the template under the same bone density conditions Additionally the study aims to determine if the use of the template affects the accuracy of bone density assessment
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