Ignite Creation Date:
2024-05-06 @ 4:32 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05011604
Status:
COMPLETED
Last Update Posted:
2021-08-18
First Post:
2021-08-07
Brief Title:
Full-Digital Workflow in Single-Tooth Implant Rehabilitation
Sponsor:
Francesco Gianfreda
Organization:
University of Rome Tor Vergata
Study Overview
Official Title:
Full-Digital Workflow in Single-Tooth Implant Rehabilitation
Status:
COMPLETED
Status Verified Date:
2021-08
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:
The digital workflow in dental implantology has been used for planning the cases with the intraoral scanners and computer tomography together helping clinicians to be more accurate and precise Today thanks to digital technology clinicians can plan from surgical to the final prosthesis using 3D models and cad-cam machines The aim of this research is to validate the full digital workflow for the single-tooth implant rehabilitation A total of 19 patients 22 implants were included in the present study with mean follow-up time of 2 years A full-digital workflow was performed on each patient through the design and printing of a surgical guide the taking of the impression with an intraoral scanner and the CAD-CAM design of the crowns
Detailed Description:
Study design The present study was a retrospective case series conducted in one clinical center in accordance with the Good Clinical Practice Guidelines GCPs following the recommendations of the World Medical Association Declaration of Helsinki-ethical principles for medical research involving human subjects as revised in Fortaleza 2013
All patients were informed about the benefits and the possible risks of a fully digital workflow and its alternatives finally a signed written consent was obtained Subject population
The current retrospective study was performed in a private clinic in Rome Italy where all patients treated by the same operator between January 2017 and June 2020 were consecutively enrolled
Patients older than 18 years
Patients in good health Asa 1 or Asa 2
Patients with healthy periodontium probing pocket depth 4 mm no bleeding on probing
Patients not requiring bone augmentation procedures Patients requiring a single implant supported reconstructions were included in the present study
Surgical and prosthetic workflow For all patients included in the study a digital impression was taken using an intraoral scanner CS3600 Carestream Dental Atlanta Ga During the same day a CBCT CS9000 3D Carestream Dental Atlanta Ga exam was performed on the mandibular or maxillary jaw with the missing tooth The stl and the dicom files were then superimposed to allow the surgical planning RealGuide 3Diemme Cantù Italy
One week after planning implant insertion was performed after the elevation of a flap with a papilla preservation technique Once designed the flap was dis-epitelized using a diamond bur Then it was elevated and reflected to increase the volume on the buccal side and exposed the bone surface After this point the implant Sweden Martina Padua Italy was inserted and another digital impression was taken
Sutures 60 were positioned monofilament-polyglecaprone suture Surgiclryl-Monofast SMI-Belgium after healing abutment positioning to stabilize the soft tissues
In the mean time the file of the impression was sent to technician and the final abutment and the provisional were designed and manufactured using cad-cam technology One week thereafter definitive abutment was positioned and screwed at 25Ncm Provisional restoration was then cemented using provisional cement Temp Bond Kerr Sybron Dental Specialities Washington DC USA removing all the possible occlusal contacts both in protrusive and in lateral positions
Sutures were removed 2 weeks postoperative Three months thereafter once osteointegration was obtained definitive zirconia restoration was positioned and cemented
Eventual deficiencies of the prosthetic rehabilitation at the time of provisional restoration contact points esthetics were noticed and fixed directly adding composite In all these cases a new impression after soft tissue maturation was performed and strategically a new crown in PMMA was designed and realized Final check before producing the zirconia element was performed positioning the crown on the abutment
All patients were informed about the benefits and the possible risks of a fully digital workflow and its alternatives finally a signed written consent was obtained Subject population
The current retrospective study was performed in a private clinic in Rome Italy where all patients treated by the same operator between January 2017 and June 2020 were consecutively enrolled
Patients older than 18 years
Patients in good health Asa 1 or Asa 2
Patients with healthy periodontium probing pocket depth 4 mm no bleeding on probing
Patients not requiring bone augmentation procedures Patients requiring a single implant supported reconstructions were included in the present study
Surgical and prosthetic workflow For all patients included in the study a digital impression was taken using an intraoral scanner CS3600 Carestream Dental Atlanta Ga During the same day a CBCT CS9000 3D Carestream Dental Atlanta Ga exam was performed on the mandibular or maxillary jaw with the missing tooth The stl and the dicom files were then superimposed to allow the surgical planning RealGuide 3Diemme Cantù Italy
One week after planning implant insertion was performed after the elevation of a flap with a papilla preservation technique Once designed the flap was dis-epitelized using a diamond bur Then it was elevated and reflected to increase the volume on the buccal side and exposed the bone surface After this point the implant Sweden Martina Padua Italy was inserted and another digital impression was taken
Sutures 60 were positioned monofilament-polyglecaprone suture Surgiclryl-Monofast SMI-Belgium after healing abutment positioning to stabilize the soft tissues
In the mean time the file of the impression was sent to technician and the final abutment and the provisional were designed and manufactured using cad-cam technology One week thereafter definitive abutment was positioned and screwed at 25Ncm Provisional restoration was then cemented using provisional cement Temp Bond Kerr Sybron Dental Specialities Washington DC USA removing all the possible occlusal contacts both in protrusive and in lateral positions
Sutures were removed 2 weeks postoperative Three months thereafter once osteointegration was obtained definitive zirconia restoration was positioned and cemented
Eventual deficiencies of the prosthetic rehabilitation at the time of provisional restoration contact points esthetics were noticed and fixed directly adding composite In all these cases a new impression after soft tissue maturation was performed and strategically a new crown in PMMA was designed and realized Final check before producing the zirconia element was performed positioning the crown on the abutment
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