Full Digital WorkflowNCT05011604
Full-Digital Workflow in Single-Tooth Implant Rehabilitation
A study testing Full-Digital Workflow in Single-Tooth Implant Rehabilitation in people with Full Digital Workflow and Edentulous Jaw, run by Francesco Gianfreda at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Full Digital Workflow, Edentulous Jaw, Implant Site Reaction
- What is being tested?
- Full-Digital Workflow in Single-Tooth Implant Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2017to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patients requiring bone augmentation procedures
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Full Digital Workflow, Edentulous Jaw, Implant Site Reaction
- Being tested
- Full-Digital Workflow in Single-Tooth Implant Rehabilitation
- Keywords
- Full-Digital Workflow, Single-Tooth Implant Rehabilitation, Digital Dentistry
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-Digital Workflow in Single-Tooth Implant RehabilitationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Implant Failure | Other | Early peri-implantitis and failed osseointegration. Receives: Device: Full-Digital Workflow in Single-Tooth Implant Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictability in cases of intercalated edentulism
Implant success
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start1 Jan 2017
- Primary completion1 Jun 2020
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Full Digital WorkflowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francesco Gianfreda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francesco Gianfreda, University of Rome Tor Vergata
- Investigators
- Luigi Canullo, Dentistry, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011604
- Sponsor's protocol ID
- 180171
- Status last verified
- Aug 2021
- First submitted
- 7 Aug 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will be available on private request to the principal investigator
Publications
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.
PubMed 33628525Stanley 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.
PubMed 30086753Flugge 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.
PubMed 27440381Mangano 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.
PubMed 32962680
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full-Digital Workflow in Single-Tooth Implant Rehabilitation
- ClinicalTrials.gov ID
- NCT05011604
- Acronym / sponsor ID
- 180171
- Conditions
- Full Digital Workflow, Edentulous Jaw, Implant Site Reaction
- Keywords
- Full-Digital Workflow, Single-Tooth Implant Rehabilitation, Digital Dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Francesco GianfredaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Implant Failure | Other | Device: Full-Digital Workflow in Single-Tooth Implant RehabilitationEarly peri-implantitis and failed osseointegration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- Patients requiring bone augmentation procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full-Digital Workflow in Single-Tooth Implant RehabilitationFor 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. | Device | Implant Failure |
Primary outcome
Predictability in cases of intercalated edentulism
Time frame: 1 year
Implant success
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Background: PubMed 33628525da 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.
- Background: PubMed 30086753Stanley 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.
- Background: PubMed 27440381Flugge 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.
- Background: PubMed 32962680Mangano 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.
- Individual participant dataSharing planned: No. Individual patient data will be available on private request to the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Canullo, Dentistry principal investigator
Private Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full-Digital Workflow in Single-Tooth Implant Rehabilitation in people with Full Digital Workflow and Edentulous Jaw, run by Francesco Gianfreda at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictability in cases of intercalated edentulism (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05011604, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.