Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404385
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2024-04-29
Brief Title:
Accuracy of Static Computer-assisted Implant Surgery in Distal Free-end Scenarios
Sponsor:
University of Valencia
Organization:
University of Valencia
Study Overview
Official Title:
Prospective Clinical Study on the Accuracy of Static Computer-assisted Implant Surgery in Patients Rehabilitated With Distal Free-end Implants Conventional Versus CAD-CAM Surgical Guides
Status:
COMPLETED
Status Verified Date:
2024-05
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:
Technological advances have influenced the approach to implant treatment One of the fields presently experiencing rapid development is static computer-assisted guided surgery sCAIS which allows transfer of the virtual implant planning to the mouth of the patient based on the use of a surgical guide In sCAIS there is a deviation between the virtually planned implant position and the actual position of the implant placed during surgery A recent review analyzed only fully guided implants and recorded a mean coronal horizontal deviation CHD of 112 mm standard deviation SD 008 a mean apical horizontal deviation AHD of 141 mm SD 01 a mean vertical deviation VD of 012 mm SD 023 and a mean angular deviation AD of 358ยบ SD 02
The aim of the present study was to compare the accuracy of CAD-CAM and conventional guides in candidates for distal free-end implant treatment and to analyze the effects of possible confounding factors inherent to the patient or the surgical technique employedA prospective controlled and blinded quasi-experimental study was carried out involving 27 patients with 76 implants distributed into two groups according to the surgical guide manufacturing approach used conventional control group CG or CAD-CAM test group TG The implants were planned virtually with the planning software and the surgical guides were manufactured Fully guided implant placement was carried out and the deviations were measured along with other secondary variables as potential confounding factors
The aim of the present study was to compare the accuracy of CAD-CAM and conventional guides in candidates for distal free-end implant treatment and to analyze the effects of possible confounding factors inherent to the patient or the surgical technique employedA prospective controlled and blinded quasi-experimental study was carried out involving 27 patients with 76 implants distributed into two groups according to the surgical guide manufacturing approach used conventional control group CG or CAD-CAM test group TG The implants were planned virtually with the planning software and the surgical guides were manufactured Fully guided implant placement was carried out and the deviations were measured along with other secondary variables as potential confounding factors
Detailed Description:
Planning of the implants is made in the ideal prosthetic position based on a previous CAD-CAM computer aided design - computer aided manufacturing wax-up sCAIS facilitates correct prosthetic emergence and therefore contributes to secure optimum esthetic and biological outcomes affording long-term stability of the soft and hard tissues
These surgical guides can be manufactured using CAD-CAM or conventional technologies in the laboratory employing drilling machines or mechanical positioners In the case of the conventional guide manufactured in the laboratory the technician creates a radiological guide that is then converted into a surgical guide - the whole process being analogic except for planning of the implants At present and with the development of digital workflows CAD-CAM procedures are used for both the design and manufacture of the surgical guide using different processes This simplifies the workflow which can reduce the costs of smaller rehabilitations
Clinical studies on accuracy published in the literature are heterogeneous with differences in the systems used the surgical technique the type of surgical guide support or the type of edentulism involvedThese data justify further research in humans focusing on fully sCAIS in order to reduce heterogeneity Furthermore a review of the literature revealed a lack of clinical publications on the accuracy of CAD-CAM surgical guides compared to conventional guides Therefore the aim of the present study was to compare the accuracy of CAD-CAM and conventional guides in candidates for distal free-end implant treatment and to analyze the effects of possible confounding factors inherent to the patient or the surgical technique employed Intra- and postoperative complications of the surgical technique were also evaluated as well as implant success and peri-implant marginal bone loss Hence the null hypothesis of the study was the absence of any difference in accuracy between both guides
A prospective controlled examiner- and statistician-blinded parallel-arm quasi-experimental study was carried out at the University of Valencia Valencia Spain Two groups were established according to the surgical guide design involved conventional control group CG or CAD-CAM test group TG
These surgical guides can be manufactured using CAD-CAM or conventional technologies in the laboratory employing drilling machines or mechanical positioners In the case of the conventional guide manufactured in the laboratory the technician creates a radiological guide that is then converted into a surgical guide - the whole process being analogic except for planning of the implants At present and with the development of digital workflows CAD-CAM procedures are used for both the design and manufacture of the surgical guide using different processes This simplifies the workflow which can reduce the costs of smaller rehabilitations
Clinical studies on accuracy published in the literature are heterogeneous with differences in the systems used the surgical technique the type of surgical guide support or the type of edentulism involvedThese data justify further research in humans focusing on fully sCAIS in order to reduce heterogeneity Furthermore a review of the literature revealed a lack of clinical publications on the accuracy of CAD-CAM surgical guides compared to conventional guides Therefore the aim of the present study was to compare the accuracy of CAD-CAM and conventional guides in candidates for distal free-end implant treatment and to analyze the effects of possible confounding factors inherent to the patient or the surgical technique employed Intra- and postoperative complications of the surgical technique were also evaluated as well as implant success and peri-implant marginal bone loss Hence the null hypothesis of the study was the absence of any difference in accuracy between both guides
A prospective controlled examiner- and statistician-blinded parallel-arm quasi-experimental study was carried out at the University of Valencia Valencia Spain Two groups were established according to the surgical guide design involved conventional control group CG or CAD-CAM test group TG
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