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Full-Digital Workflow in Single-Tooth Implant Rehabilitation

Primary Purpose

Full Digital Workflow, Edentulous Jaw, Implant Site Reaction

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Full-Digital Workflow in Single-Tooth Implant Rehabilitation
Sponsored by
Francesco Gianfreda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Full Digital Workflow focused on measuring Full-Digital Workflow, Single-Tooth Implant Rehabilitation, Digital Dentistry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Patients requiring bone augmentation procedures

Sites / Locations

  • Luigi Canullo

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Implant Failure

Arm Description

Early peri-implantitis and failed osseointegration.

Outcomes

Primary Outcome Measures

Predictability in cases of intercalated edentulism
Implant success

Secondary Outcome Measures

Full Information

First Posted
August 7, 2021
Last Updated
August 13, 2021
Sponsor
Francesco Gianfreda
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1. Study Identification

Unique Protocol Identification Number
NCT05011604
Brief Title
Full-Digital Workflow in Single-Tooth Implant Rehabilitation
Official Title
Full-Digital Workflow in Single-Tooth Implant Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Francesco Gianfreda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 6.0 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 25N/cm 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Full Digital Workflow, Edentulous Jaw, Implant Site Reaction
Keywords
Full-Digital Workflow, Single-Tooth Implant Rehabilitation, Digital Dentistry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implant Failure
Arm Type
Other
Arm Description
Early peri-implantitis and failed osseointegration.
Intervention Type
Device
Intervention Name(s)
Full-Digital Workflow in Single-Tooth Implant Rehabilitation
Intervention Description
For all patients included in the study, a digital impression was taken using an intraoral scanner. A CBCT 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. Then it was elevated and reflected to increase the volume on the buccal side and exposed the bone surface. After this point, the implant was inserted, and another digital impression was taken. Sutures 6.0 were positioned after healing abutment positioning to stabilize the soft tissues. The final abutment and the provisional were designed and manufactured using cad-cam technology. One week thereafter, definitive abutment was positioned. Provisional restoration was then cemented using provisional cement removing all the possible occlusal contacts both in protrusive and in lateral positions. Three months thereafter, once osteointegration was obtained, definitive zirconia restoration was positioned and cemented.
Primary Outcome Measure Information:
Title
Predictability in cases of intercalated edentulism
Description
Implant success
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Patients requiring bone augmentation procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Canullo, Dentistry
Organizational Affiliation
Private Practice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Luigi Canullo
City
Rome
ZIP/Postal Code
00185
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual patient data will be available on private request to the principal investigator
Citations:
PubMed Identifier
33628525
Citation
da Silva Salomao GV, Chun EP, Panegaci RDS, Santos FT. Analysis of Digital Workflow in Implantology. Case Rep Dent. 2021 Feb 15;2021:6655908. doi: 10.1155/2021/6655908. eCollection 2021.
Results Reference
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PubMed Identifier
30086753
Citation
Stanley M, Paz AG, Miguel I, Coachman C. Fully digital workflow, integrating dental scan, smile design and CAD-CAM: case report. BMC Oral Health. 2018 Aug 7;18(1):134. doi: 10.1186/s12903-018-0597-0.
Results Reference
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PubMed Identifier
27440381
Citation
Flugge T, Derksen W, Te Poel J, Hassan B, Nelson K, Wismeijer D. Registration of cone beam computed tomography data and intraoral surface scans - A prerequisite for guided implant surgery with CAD/CAM drilling guides. Clin Oral Implants Res. 2017 Sep;28(9):1113-1118. doi: 10.1111/clr.12925. Epub 2016 Jul 20.
Results Reference
background
PubMed Identifier
32962680
Citation
Mangano FG, Admakin O, Bonacina M, Lerner H, Rutkunas V, Mangano C. Trueness of 12 intraoral scanners in the full-arch implant impression: a comparative in vitro study. BMC Oral Health. 2020 Sep 22;20(1):263. doi: 10.1186/s12903-020-01254-9.
Results Reference
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Full-Digital Workflow in Single-Tooth Implant Rehabilitation

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