Surgery, Computer-AssistedNCT04344808
Dynamic Navigation System in Implantology
A study testing Dynamic navigation system and Freehand implant placement in people with Surgery, Computer-Assisted and Dental Implants, run by University of Barcelona at 1 site in Spain.
Trial summary
This study consists in a randomized controlled trial which objective is to assess the accuracy of a dynamic navigation system in dental implant placement in partially edentulous patients compared with the conventional freehand method. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery, Computer-Assisted, Dental Implants
- What is being tested?
- Dynamic navigation system and Freehand implant placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2020to Feb 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
- Partially edentulous patients that requires at least the placement of one dental implant
- Healthy patients ASA I and II (American Society of Anesthesiologists classification)
- Over 18 years old patients
Who cannot join
- Totally edentulous patients
- Systemic or local conditions that contraindicates dental implant surgery
- Patients with less than 3 teeth in the jaw.
Trial locations and contacts
1 site in 1 country.
Rui Figueiredo contact
Spain1 site
Universitat de Barcelona
Barcelona, 08907
Adrià Jorba-García, DDS, 0034 699183949, adriajorba@hotmail.com
About this study
Official title: Accuracy and Patient-Reported Outcome Measures (PROMs) of a Dynamic Navigation System in Implantology: A Randomized Controlled Trial
This study consists in a randomized controlled trial which objective is to assess the accuracy of a dynamic navigation system in dental implant placement in partially edentulous patients compared with the conventional freehand method.
Read the detailed description
This is a prospective randomized clinical trial.
Each patient enrolled in this trial will be randomly allocated to one group ( Navigation group or Freehand groups). Preoperative virtual planification of dental implants on a pre-acquired cone beam computed tomography (CBCT) will be performed for each patient using the same system.
During the surgical phase, depending on which group is allocated the patient one surgical approach or other will be used. Then after the surgical procedure a PROMs questionnaire will be asked to the patients.
Finally a postoperative CBCT will be performed and overlapped with the preoperative CBCT (with the implants planification) and implant position deviations between the planned and final position will be measured.
The study devices are CE- (Conformité Européenne, meaning European Conformity) marked products and used within their intended use.
- Conditions
- Surgery, Computer-Assisted, Dental Implants
- Being tested
- Dynamic navigation system, Freehand implant placement
- Keywords
- Surgery, Computer-Assisted, Dental Implants, Navigation system, Dynamic computer-assisted surgery, Implantology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic navigation systemDevice
Also called Dynamic computer assisted surgery
The navigation system allows clinicians, using a specific software, to visualize the position of the surgical drill (tip location and shaft axis direction) on the reconstructed 3D image of the pre-acquired CBCT. The software guides the surgeon, in real-time, to the preoperative planned position.
Freehand implant placementDevice
Also called Non-guided implant placement
Dental implants will be placed without any guidance once a virtually planning of the ideal position on the CBCT is done
| Study group | Role | What they receive |
|---|---|---|
| Navigation group | Experimental | Dental implants will be placed using a dynamic computer assisted surgery system Receives: Device: Dynamic navigation system |
| Freehand group | Active comparator | Dental implants will be place without any guidance. Only virtually planning the ideal position on a 3D image (Cone beam computed tomography) Receives: Device: Freehand implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angular deviation
angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees
Measured: 3 months post operative
Platform 3D deviation
global deviation at the platform of the dental implant between the virtual planned position and the final position of the dental implant measured in the 3 axes of the space (3D deviation). Measured in millimeters (mm).
Measured: 3 months post operative
Apex 3D deviation
global deviation at the apex of the dental implant between the virtual planned position and the final position of the dental implant measured in the 3 axes of the space (3D deviation). Measured in millimeters (mm).
Measured: 3 months post operative
Platform 2D deviation
Lateral deviation at the platform of the dental implant between the virtual planned position and the final position of the dental implant measured in 2 axes of the space (x and y, 2D deviation). Measured in millimeters (mm).
Measured: 3 months post operative
Apex depth deviation
Depth deviation of the apex of the dental implant between the virtual planned position and the final position of the dental implant in the Z-axis. Measured in millimeters (mm).
Measured: 3 months post operative
Secondary outcomes (1)
Patient-reported outcome measures (PROMs) questionnaire
Patients perception of their functional well-being and health status during the dental implant treatment with a navigation system. We will use OHIP-14 (Oral Health Impact Profile) questionnaire.
Measured: One week post operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study startApr 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Surgery, Computer-AssistedStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui Figueiredo, University of Barcelona
- Investigators
- Adrià Jorba-García, Principal investigator, University of BarcelonaRui Figueiredo, Study director, University of BarcelonaEduard Valmaseda-Castellón, Study chair, University of BarcelonaOctavi Camps-Font, Study chair, University of BarcelonaJavier Bara-Casaus, Study chair, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344808
- Sponsor's protocol ID
- NavigationSystem
- Status last verified
- Apr 2020
- First submitted
- 30 Mar 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vercruyssen M, Fortin T, Widmann G, Jacobs R, Quirynen M. Different techniques of static/dynamic guided implant surgery: modalities and indications. Periodontol 2000. 2014 Oct;66(1):214-27. doi: 10.1111/prd.12056.
PubMed 25123770Aydemir CA, Arisan V. Accuracy of dental implant placement via dynamic navigation or the freehand method: A split-mouth randomized controlled clinical trial. Clin Oral Implants Res. 2020 Mar;31(3):255-263. doi: 10.1111/clr.13563. Epub 2019 Dec 29.
PubMed 31829457D'haese J, Ackhurst J, Wismeijer D, De Bruyn H, Tahmaseb A. Current state of the art of computer-guided implant surgery. Periodontol 2000. 2017 Feb;73(1):121-133. doi: 10.1111/prd.12175.
PubMed 28000275Jorba-Garcia A, Figueiredo R, Gonzalez-Barnadas A, Camps-Font O, Valmaseda-Castellon E. Accuracy and the role of experience in dynamic computer guided dental implant surgery: An in-vitro study. Med Oral Patol Oral Cir Bucal. 2019 Jan 1;24(1):e76-e83. doi: 10.4317/medoral.22785.
PubMed 30573712Block MS, Emery RW. Static or Dynamic Navigation for Implant Placement-Choosing the Method of Guidance. J Oral Maxillofac Surg. 2016 Feb;74(2):269-77. doi: 10.1016/j.joms.2015.09.022. Epub 2015 Sep 30.
PubMed 26452429Emery RW, Merritt SA, Lank K, Gibbs JD. Accuracy of Dynamic Navigation for Dental Implant Placement-Model-Based Evaluation. J Oral Implantol. 2016 Oct;42(5):399-405. doi: 10.1563/aaid-joi-D-16-00025. Epub 2016 Jun 6.
PubMed 27267658Jung RE, Schneider D, Ganeles J, Wismeijer D, Zwahlen M, Hammerle CH, Tahmaseb A. Computer technology applications in surgical implant dentistry: a systematic review. Int J Oral Maxillofac Implants. 2009;24 Suppl:92-109.
PubMed 19885437
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Patient-Reported Outcome Measures (PROMs) of a Dynamic Navigation System in Implantology: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04344808
- Acronym / sponsor ID
- NavigationSystem
- Conditions
- Surgery, Computer-Assisted, Dental Implants
- Keywords
- Surgery, Computer-Assisted, Dental Implants, Navigation system, Dynamic computer-assisted surgery, Implantology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 14 Apr 2020 (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.
This study consists in a randomized controlled trial which objective is to assess the accuracy of a dynamic navigation system in dental implant placement in partially edentulous patients compared with the conventional freehand method.
Detailed description
This is a prospective randomized clinical trial.
Each patient enrolled in this trial will be randomly allocated to one group ( Navigation group or Freehand groups). Preoperative virtual planification of dental implants on a pre-acquired cone beam computed tomography (CBCT) will be performed for each patient using the same system.
During the surgical phase, depending on which group is allocated the patient one surgical approach or other will be used. Then after the surgical procedure a PROMs questionnaire will be asked to the patients.
Finally a postoperative CBCT will be performed and overlapped with the preoperative CBCT (with the implants planification) and implant position deviations between the planned and final position will be measured.
The study devices are CE- (Conformité Européenne, meaning European Conformity) marked products and used within their intended use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navigation group | Experimental | Device: Dynamic navigation systemDental implants will be placed using a dynamic computer assisted surgery system |
| Freehand group | Active comparator | Device: Freehand implant placementDental implants will be place without any guidance. Only virtually planning the ideal position on a 3D image (Cone beam computed tomography) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Partially edentulous patients that requires at least the placement of one dental implant
- Healthy patients ASA I and II (American Society of Anesthesiologists classification)
- Over 18 years old patients
Key exclusion criteria (3 listed)
- Totally edentulous patients
- Systemic or local conditions that contraindicates dental implant surgery
- Patients with less than 3 teeth in the jaw.
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 |
|---|---|---|
| Dynamic navigation systemAlso: Dynamic computer assisted surgeryThe navigation system allows clinicians, using a specific software, to visualize the position of the surgical drill (tip location and shaft axis direction) on the reconstructed 3D image of the pre-acquired CBCT. The software guides the surgeon, in real-time, to the preoperative planned position. | Device | Navigation group |
| Freehand implant placementAlso: Non-guided implant placementDental implants will be placed without any guidance once a virtually planning of the ideal position on the CBCT is done | Device | Freehand group |
Primary outcome
Angular deviation
Time frame: 3 months post operative
angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees
Platform 3D deviation
Time frame: 3 months post operative
global deviation at the platform of the dental implant between the virtual planned position and the final position of the dental implant measured in the 3 axes of the space (3D deviation). Measured in millimeters (mm).
Apex 3D deviation
Time frame: 3 months post operative
global deviation at the apex of the dental implant between the virtual planned position and the final position of the dental implant measured in the 3 axes of the space (3D deviation). Measured in millimeters (mm).
Platform 2D deviation
Time frame: 3 months post operative
Lateral deviation at the platform of the dental implant between the virtual planned position and the final position of the dental implant measured in 2 axes of the space (x and y, 2D deviation). Measured in millimeters (mm).
Apex depth deviation
Time frame: 3 months post operative
Depth deviation of the apex of the dental implant between the virtual planned position and the final position of the dental implant in the Z-axis. Measured in millimeters (mm).
1 secondary outcome
Patient-reported outcome measures (PROMs) questionnaire
Time frame: One week post operative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Background: PubMed 25123770Vercruyssen M, Fortin T, Widmann G, Jacobs R, Quirynen M. Different techniques of static/dynamic guided implant surgery: modalities and indications. Periodontol 2000. 2014 Oct;66(1):214-27. doi: 10.1111/prd.12056.
- Background: PubMed 31829457Aydemir CA, Arisan V. Accuracy of dental implant placement via dynamic navigation or the freehand method: A split-mouth randomized controlled clinical trial. Clin Oral Implants Res. 2020 Mar;31(3):255-263. doi: 10.1111/clr.13563. Epub 2019 Dec 29.
- Background: PubMed 28000275D'haese J, Ackhurst J, Wismeijer D, De Bruyn H, Tahmaseb A. Current state of the art of computer-guided implant surgery. Periodontol 2000. 2017 Feb;73(1):121-133. doi: 10.1111/prd.12175.
- Background: PubMed 30573712Jorba-Garcia A, Figueiredo R, Gonzalez-Barnadas A, Camps-Font O, Valmaseda-Castellon E. Accuracy and the role of experience in dynamic computer guided dental implant surgery: An in-vitro study. Med Oral Patol Oral Cir Bucal. 2019 Jan 1;24(1):e76-e83. doi: 10.4317/medoral.22785.
- Background: PubMed 26452429Block MS, Emery RW. Static or Dynamic Navigation for Implant Placement-Choosing the Method of Guidance. J Oral Maxillofac Surg. 2016 Feb;74(2):269-77. doi: 10.1016/j.joms.2015.09.022. Epub 2015 Sep 30.
- Background: PubMed 27267658Emery RW, Merritt SA, Lank K, Gibbs JD. Accuracy of Dynamic Navigation for Dental Implant Placement-Model-Based Evaluation. J Oral Implantol. 2016 Oct;42(5):399-405. doi: 10.1563/aaid-joi-D-16-00025. Epub 2016 Jun 6.
- Background: PubMed 19885437Jung RE, Schneider D, Ganeles J, Wismeijer D, Zwahlen M, Hammerle CH, Tahmaseb A. Computer technology applications in surgical implant dentistry: a systematic review. Int J Oral Maxillofac Implants. 2009;24 Suppl:92-109.
- 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.
Rui Figueiredo contact
Adrià Jorba-García principal investigator
University of Barcelona
Rui Figueiredo study director
University of Barcelona
Eduard Valmaseda-Castellón study chair
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic navigation system and Freehand implant placement in people with Surgery, Computer-Assisted and Dental Implants, run by University of Barcelona at 1 site in Spain.
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 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: status not confirmed, as of the sponsor's last update on 14 Apr 2020. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adrià Jorba-García, DDS (0034 699183949, adriajorba@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angular deviation (time frame: 3 months post operative). The study lists 5 primary outcomes in all. 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 NCT04344808, which also lists 7 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 Apr 2020.