Full-Digital Workflow in Single-Tooth Implant Rehabilitation

August 13, 2021 updated by: Francesco Gianfreda
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00185
        • Luigi Canullo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Implant Failure
Early peri-implantitis and failed osseointegration.
Device: Full-Digital Workflow in Single-Tooth Implant Rehabilitation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictability in cases of intercalated edentulism
Time Frame: 1 year
Implant success
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Francesco Gianfreda

Investigators

  • Principal Investigator: Luigi Canullo, Dentistry, Private Practice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

August 7, 2021

First Submitted That Met QC Criteria

August 13, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 180171

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual patient data will be available on private request to the principal investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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