Partially Edentulous MaxillaDIGIMPLGDNCT03814655
Evaluation of the Accuracy of Full Digital Workflow for Guided Implant Surgery Using the R2 Gate Software
A study testing Full digital workflow and Partially digital workflow in people with Partially Edentulous Maxilla and Partially Edentulous Mandible, run by Concordia Dent Srl at 2 sites in Romania.
Trial summary
The primary aim of the present study is to compare the accuracy of a full digital workflow for dental implants insertion to a partially digital workflow, for a limited edentulous space (1 to 3 dental units), in the maxilla or mandible. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Partially Edentulous Maxilla, Partially Edentulous Mandible
- What is being tested?
- Full digital workflow and Partially digital workflow
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesRomania
- Study dates
- 1 Jul 2019to 13 Jul 2020
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Kennedy Class III partially edentulism with 3 or less missing teeth,
- Good general health with no contraindications for implant surgery,
- Acceptance of dental implant treatment,
- Acceptance of 1 or 2 CBCTs.
Who cannot join
- Limited bone volume with stadial bone graft requirement,
- Limited mouth opening (impossible to use the surgical stent),
- Parkinson disease (impossible to perform an accurate CBCT).
Trial locations and contacts
2 sites in 1 country.
Romania2 sites
Concordia Dent Clinic
Bucharest, 041335
"Carol Davila"University of Medicine and Pharmacy
Bucharest
About this study
Official title: Evaluation of the Accuracy of Full Digital Workflow for Guided Implant Surgery Using the R2 Gate Software - a Randomized Clinical Trial (RCT)
The primary aim of the present study is to compare the accuracy of a full digital workflow for dental implants insertion to a partially digital workflow, for a limited edentulous space (1 to 3 dental units), in the maxilla or mandible.
Read the detailed description
Improvements of dental digital technologies are nowadays enabling clinicians to take the digital impressions of the dental arches, therefore avoiding the use of conventional impression materials. Digital impression procedures are claimed to be an approach to improve the accuracy of dental restorations by minimizing the error prone to conventional impression and gypsum model casting, enabling a high degree of standardization. Patients often prefer intraoral scan when compared to the traditional impression. Digital impression is also recommended when patients have remaining teeth that are extremely mobile or misaligned, due to the risk of exfoliation during the conventional impression procedure.
Despite its poor scientific and clinical evidence, the use of digital technologies into the daily practice registers a rapidly growing.
The precision of digital impressions depends on two different parameters: the resolution of the optical scanning system, and the precision of the matching algorithm which may significantly influence the precision of full arch scans. In order to minimize the effect of matching artifacts, only small parts of the dental arch in close vicinity of the teeth are recommended to be scanned.
For prosthetic restoration purpose, several studies regarding the accuracy of digital vs analogue impression have been performed, but none comparing the accuracy of digital vs partially digital workflow for prosthetically driven guided dental implant insertion.
- Being tested
- Full digital workflow, Partially digital workflow
- Keywords
- Dental implants, digital workflow, guided surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full digital workflowProcedure or surgery
Dental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be full digital.
Partially digital workflowProcedure or surgery
Dental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be partially digital.
| Study group | Role | What they receive |
|---|---|---|
| Full digital workflow | Experimental | 1. Intraoral scan of the partially edentulous site, antagonists and occlusion registration. Radiopaque tray customization over the partially edentulous arch.
2. CBCT with customized radiopaque tray.
3. Merging files in R2 Gate software and implant planning.
4. Guided implant insertion with immediate loading, if possible. Megagen dental implants will be inserted.
5. Digital impression for final screw-retained crown/bridge.
6. Assessment of accuracy by comparing stl files (planned and postimplant insertion). Receives: Procedure: Full digital workflow |
| Partially digital workflow | Active comparator | 1. Impression of the edentulous arch and antagonist, occlusion registration. Radiopaque tray customization over the edentulous arch.
2. CBCT with customized radiopaque tray.
3. Stone models alone, maximum intercuspal position and customized radiopaque tray will be scanned using a desktop scanner.
4. Merging files (CBCT and model stl) in R2 Gate software and implant planning.
5. Guided implant insertion with immediate loading, if possible. Megagen dental implants will be inserted.
6. Classic impression in customized tray with Impregum.
7. Functional models will be scanned using the same desktop scanner.
8. Final screw-retained crown/bridge manufacturing.
9. Assessment of accuracy by comparing stl files (planned and postimplant insertion). Receives: Procedure: Partially digital workflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of dental implant insertion
Accuracy is described, by the International Organization for Standardization (ISO) standard 5725-1, through the use of two parameters: trueness and precision.
Trueness refers to the deviation between the actual dimension of the measured object and the resulting measurement, while precision indicates how closely repeated the measurements in a set are.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start1 Jul 2019
- Primary completion15 Feb 2020
- Study completion13 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Partially Edentulous MaxillaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 54 partially edentulous patients filling the inclusion criteria and with signed consent form are expected to be enrolled in this RCT. Each patient will be randomly assigned to one of the following protocol for dental implant insertion: * Full digital workflow (n=27 patients/sites), * Partially digital workflow (n=27 patients/sites).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concordia Dent Srl
- Sponsor type
- University, hospital or other
- Collaborators
- Carol Davila University of Medicine and Pharmacy, MINEC
- Responsible party
- Principal investigator, Corina Marilena Cristache, Concordia Dent Srl
- Investigators
- Corina Marilena Cristache, DMD, PhD, Principal investigator, Carol Davila University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814655
- Sponsor's protocol ID
- MINEC 2/2019
- Acronym
- DIGIMPLGD
- Status last verified
- Jul 2020
- First submitted
- 20 Jan 2019
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seelbach P, Brueckel C, Wostmann B. Accuracy of digital and conventional impression techniques and workflow. Clin Oral Investig. 2013 Sep;17(7):1759-64. doi: 10.1007/s00784-012-0864-4. Epub 2012 Oct 21.
PubMed 23086333Mehl A, Ender A, Mormann W, Attin T. Accuracy testing of a new intraoral 3D camera. Int J Comput Dent. 2009;12(1):11-28. English, German.
PubMed 19213357Pinto A, Raffone C. Postextraction computer-guided implant surgery in partially edentate patients with metal restorations: a case report. Oral Implantol (Rome). 2017 Apr 10;10(1):71-77. doi: 10.11138/orl/2017.10.1.071. eCollection 2017 Jan-Mar.
PubMed 28757938Joda T, Ferrari M, Braegger U. A digital approach for one-step formation of the supra-implant emergence profile with an individualized CAD/CAM healing abutment. J Prosthodont Res. 2016 Jul;60(3):220-3. doi: 10.1016/j.jpor.2016.01.005. Epub 2016 Feb 9.
PubMed 26868927Cristache CM, Gurbanescu S. Accuracy Evaluation of a Stereolithographic Surgical Template for Dental Implant Insertion Using 3D Superimposition Protocol. Int J Dent. 2017;2017:4292081. doi: 10.1155/2017/4292081. Epub 2017 May 7.
PubMed 28555157
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of Full Digital Workflow for Guided Implant Surgery Using the R2 Gate Software - a Randomized Clinical Trial (RCT)
- ClinicalTrials.gov ID
- NCT03814655
- Acronym / sponsor ID
- DIGIMPLGD / MINEC 2/2019
- Keywords
- Dental implants, digital workflow, guided surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Concordia Dent SrlUniversity, hospital or other
- Collaborators
- Carol Davila University of Medicine and Pharmacy, MINEC
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 24 Jan 2019 (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 primary aim of the present study is to compare the accuracy of a full digital workflow for dental implants insertion to a partially digital workflow, for a limited edentulous space (1 to 3 dental units), in the maxilla or mandible.
Detailed description
Improvements of dental digital technologies are nowadays enabling clinicians to take the digital impressions of the dental arches, therefore avoiding the use of conventional impression materials. Digital impression procedures are claimed to be an approach to improve the accuracy of dental restorations by minimizing the error prone to conventional impression and gypsum model casting, enabling a high degree of standardization. Patients often prefer intraoral scan when compared to the traditional impression. Digital impression is also recommended when patients have remaining teeth that are extremely mobile or misaligned, due to the risk of exfoliation during the conventional impression procedure.
Despite its poor scientific and clinical evidence, the use of digital technologies into the daily practice registers a rapidly growing.
The precision of digital impressions depends on two different parameters: the resolution of the optical scanning system, and the precision of the matching algorithm which may significantly influence the precision of full arch scans. In order to minimize the effect of matching artifacts, only small parts of the dental arch in close vicinity of the teeth are recommended to be scanned.
For prosthetic restoration purpose, several studies regarding the accuracy of digital vs analogue impression have been performed, but none comparing the accuracy of digital vs partially digital workflow for prosthetically driven guided dental implant insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 54 partially edentulous patients filling the inclusion criteria and with signed consent form are expected to be enrolled in this RCT. Each patient will be randomly assigned to one of the following protocol for dental implant insertion: * Full digital workflow (n=27 patients/sites), * Partially digital workflow (n=27 patients/sites).
| Arm | Type | Receives |
|---|---|---|
| Full digital workflow | Experimental | Procedure: Full digital workflow1. Intraoral scan of the partially edentulous site, antagonists and occlusion registration. Radiopaque tray customization over the partially edentulous arch. 2. CBCT with customized radiopaque tray. 3. Merging files in R2 Gate software and implant planning. 4. Guided implant insertion with immediate loading, if possible. Megagen dental implants will be inserted. 5. Digital impression for final screw-retained crown/bridge. 6. Assessment of accuracy by comparing stl files (planned and postimplant insertion). |
| Partially digital workflow | Active comparator | Procedure: Partially digital workflow1. Impression of the edentulous arch and antagonist, occlusion registration. Radiopaque tray customization over the edentulous arch. 2. CBCT with customized radiopaque tray. 3. Stone models alone, maximum intercuspal position and customized radiopaque tray will be scanned using a desktop scanner. 4. Merging files (CBCT and model stl) in R2 Gate software and implant planning. 5. Guided implant insertion with immediate loading, if possible. Megagen dental implants will be inserted. 6. Classic impression in customized tray with Impregum. 7. Functional models will be scanned using the same desktop scanner. 8. Final screw-retained crown/bridge manufacturing. 9. Assessment of accuracy by comparing stl files (planned and postimplant insertion). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Kennedy Class III partially edentulism with 3 or less missing teeth,
- Good general health with no contraindications for implant surgery,
- Acceptance of dental implant treatment,
- Acceptance of 1 or 2 CBCTs.
Key exclusion criteria (3 listed)
- Limited bone volume with stadial bone graft requirement,
- Limited mouth opening (impossible to use the surgical stent),
- Parkinson disease (impossible to perform an accurate CBCT).
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 workflowDental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be full digital. | Procedure or surgery | Full digital workflow |
| Partially digital workflowDental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be partially digital. | Procedure or surgery | Partially digital workflow |
Primary outcome
Accuracy of dental implant insertion
Time frame: 6 weeks
Accuracy is described, by the International Organization for Standardization (ISO) standard 5725-1, through the use of two parameters: trueness and precision. Trueness refers to the deviation between the actual dimension of the measured object and the resulting measurement, while precision indicates how closely repeated the measurements in a set are.
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 14 Jul 2020.
- Background: PubMed 23086333Seelbach P, Brueckel C, Wostmann B. Accuracy of digital and conventional impression techniques and workflow. Clin Oral Investig. 2013 Sep;17(7):1759-64. doi: 10.1007/s00784-012-0864-4. Epub 2012 Oct 21.
- Background: PubMed 19213357Mehl A, Ender A, Mormann W, Attin T. Accuracy testing of a new intraoral 3D camera. Int J Comput Dent. 2009;12(1):11-28. English, German.
- Background: PubMed 28757938Pinto A, Raffone C. Postextraction computer-guided implant surgery in partially edentate patients with metal restorations: a case report. Oral Implantol (Rome). 2017 Apr 10;10(1):71-77. doi: 10.11138/orl/2017.10.1.071. eCollection 2017 Jan-Mar.
- Background: PubMed 26868927Joda T, Ferrari M, Braegger U. A digital approach for one-step formation of the supra-implant emergence profile with an individualized CAD/CAM healing abutment. J Prosthodont Res. 2016 Jul;60(3):220-3. doi: 10.1016/j.jpor.2016.01.005. Epub 2016 Feb 9.
- Background: PubMed 28555157Cristache CM, Gurbanescu S. Accuracy Evaluation of a Stereolithographic Surgical Template for Dental Implant Insertion Using 3D Superimposition Protocol. Int J Dent. 2017;2017:4292081. doi: 10.1155/2017/4292081. Epub 2017 May 7.
- Individual participant dataSharing planned: No
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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.
Corina Marilena Cristache, DMD, PhD principal investigator
Carol Davila University of Medicine and Pharmacy
2 sites 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 and Partially digital workflow in people with Partially Edentulous Maxilla and Partially Edentulous Mandible, run by Concordia Dent Srl at 2 sites in Romania.
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 4 inclusion and 3 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 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania. 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?
Accuracy of dental implant insertion (time frame: 6 weeks). 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 NCT03814655, which also lists 5 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 14 Jul 2020.