Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592066
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Digital Intraoral Scanning With and Without Prefabricated Landmarks Versus Conventional Impression Technique
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Accuracy of Digital Intraoral Scanning With and Without Prefabricated Landmarks Versus Conventional Impression Technique for Mandibular Implant Supported Full-Arch Prosthesis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this clinical trial is to evaluate the accuracy of digital implant impressions with or without prefabricated landmarks between scan bodies compared to conventional impression technique in mandibular full-arch implant cases
Detailed Description:
Implant-supported full arch dental prostheses are crucial and reliable alternatives for individuals with missing teeth in their jaws The initial phase in the production of implant-supported prostheses involves the impression-taking process Inaccurate impressions can result in a misfit between the prosthesis and implant abutment potentially causing both mechanical and biological complications that can adversely affect the long-term viability of the implants Therefore the precision of impressions is of utmost importance particularly for prostheses supported by multiple implants
The conventional approach to obtaining impressions for multiple implants involves the use of an open-tray technique widely adopted in dental practice In this method impression copings are connected to prevent rotational movements making it a preferable choice compared to the non-splinting technique Nevertheless this procedure is complex less efficient and demands considerable clinical expertise It is advised for use by experienced dentists as those lacking experience have shown a notably higher rate of unsuccessful outcomes when employing the splinting technique6 Additionally various factors such as patients pharyngeal reflex and the potential deformation of impression materials can influence the accuracy of implant impressions in the conventional workflow
With the advancement of computer-aided designcomputer-aided manufacturing CADCAM and digital technologies the intraoral scanner IOS has gained popularity for capturing implant positions In clinical practice IOSs are valued for their comfort efficiency and practicality However its important to note that IOSs cannot completely replace traditional methods When it comes to implant-supported fixed dental prostheses intraoral scanners can effectively be used for single- and three-unit implant scanning
In a study from 2020 Revell et al recommended specific scanners such as Primescan for complete-arch implant impressions due to their low deviation values at the implant platform level Nevertheless the accuracy of older models of intraoral scanners may not be reliable when scanning edentulous spaces with long inter-implant distances or fully edentulous jaws particularly in the hands of inexperienced operators
Previous research has introduced custom-designed scan bodies featuring an extensional structure to achieve dependable digital full-arch implant impressions Typically these platforms necessitate the use of custom-made scan bodies or a secondary scan to obtain mucosal information In this context this study is conducted to present newly designed prefabricated landmarks between the scan bodies to offer a solution for digital scanning of a mandibular full-arch implant Therefore the aim of this study is to evaluate and compare the accuracy of digital intraoral scanning with or without prefabricated landmarks to conventional impression techniques in mandibular full-arch implant cases
The null hypothesis posits that there would be no significant difference in accuracy between digital intraoral scanning with or without prefabricated landmarks between scan bodies and conventional impression techniques
The conventional approach to obtaining impressions for multiple implants involves the use of an open-tray technique widely adopted in dental practice In this method impression copings are connected to prevent rotational movements making it a preferable choice compared to the non-splinting technique Nevertheless this procedure is complex less efficient and demands considerable clinical expertise It is advised for use by experienced dentists as those lacking experience have shown a notably higher rate of unsuccessful outcomes when employing the splinting technique6 Additionally various factors such as patients pharyngeal reflex and the potential deformation of impression materials can influence the accuracy of implant impressions in the conventional workflow
With the advancement of computer-aided designcomputer-aided manufacturing CADCAM and digital technologies the intraoral scanner IOS has gained popularity for capturing implant positions In clinical practice IOSs are valued for their comfort efficiency and practicality However its important to note that IOSs cannot completely replace traditional methods When it comes to implant-supported fixed dental prostheses intraoral scanners can effectively be used for single- and three-unit implant scanning
In a study from 2020 Revell et al recommended specific scanners such as Primescan for complete-arch implant impressions due to their low deviation values at the implant platform level Nevertheless the accuracy of older models of intraoral scanners may not be reliable when scanning edentulous spaces with long inter-implant distances or fully edentulous jaws particularly in the hands of inexperienced operators
Previous research has introduced custom-designed scan bodies featuring an extensional structure to achieve dependable digital full-arch implant impressions Typically these platforms necessitate the use of custom-made scan bodies or a secondary scan to obtain mucosal information In this context this study is conducted to present newly designed prefabricated landmarks between the scan bodies to offer a solution for digital scanning of a mandibular full-arch implant Therefore the aim of this study is to evaluate and compare the accuracy of digital intraoral scanning with or without prefabricated landmarks to conventional impression techniques in mandibular full-arch implant cases
The null hypothesis posits that there would be no significant difference in accuracy between digital intraoral scanning with or without prefabricated landmarks between scan bodies and conventional impression techniques
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None