Dental ImplantsNCT06155799
Accuracy of Dynamic Navigation System on Zygomatic Implant Placement
A study testing Freehand zygomatic implant placement in people with Dental Implants and Surgery, Computer-Assisted, 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 zygomatic implant placement in partially or total edentulous patients in the upper jaw 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
- Dental Implants, Surgery, Computer-Assisted
- What is being tested?
- Freehand zygomatic implant placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSpain
- Study dates
- 15 Nov 2022to 15 Jul 2024
- 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
- Partial or total edentulous maxilla
- Large bone atrophy that avoids possible conventional implant placement
- Over 18 years old patients
Who cannot join
- Patients with facial bone disease that contraindicates conventional or zygomatic implants placement.
- Systemic or local conditions that contraindicates oral surgery.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Odontológic de Barcelona
L'Hospitalet de Llobregat, Barcelona
BASSEL TRABOULSI GARET, DDS, 616239499, basselt.121@gmail.com
About this study
Official title: Accuracy of Dynamic Navigation System on Zygomatic Implant Placement: A Randomized Clinical Trial
This study consists in a randomized controlled trial which objective is to assess the accuracy of a dynamic navigation system in zygomatic implant placement in partially or total edentulous patients in the upper jaw compared with the conventional freehand method.
Read the detailed description
The present study is a prospective randomized clinical trial.
Each patient enrolled in this trial will be randomly allocated to on group (Navigation group (test group) or Freehand group (control group)). Preoperative virtual planification of zygomatic an conventional implants on a prerequired cone beam computed tomography (CBCT) with radiographic markers (tooth if possible or micro implants if not possible) will be performed for each patient.
The patient will be randomly allocated in one group just before the surgery, and the surgical procedure will be performed according the surgery protocol of each group. 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 European Conformity (CE) marked products and used within their intended use.
- Conditions
- Dental Implants, Surgery, Computer-Assisted
- Being tested
- Freehand zygomatic implant placement
- Keywords
- Surgery, Computer-Assisted, Dental implant, Navigation system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freehand zygomatic implant placementDevice
Zygomatic implants will be placed without any guidance after preoperative virtual planning has been performed.
| Study group | Role | What they receive |
|---|---|---|
| Navigation group | Experimental | Zygomatic implant placement by dynamic computer assisted surgery system. Receives: Device: Freehand zygomatic implant placement |
| Freehand group | Active comparator | Zygomatic implant placement by Freehand, without any guidance. Receives: Device: Freehand zygomatic 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: 1 month
Platform 3D deviation
Global deviation at the platform of the zygomatic 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: 1 month
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: 1 month
Secondary outcomes (3)
Patient-reported outcome measures questionnaire
Patients perception of therapy functional well-being and health status during the dental implant treatment with a navigation system. The scale goes from 0 to 4, where higher scores mean worse outcome.
Measured: One week post operative
Time of surgery
Two times of surgery were recorded: time of drilling, from the first drilling of the first zygomatic implant to the last zygomatic implant placement; and time of complete surgery procedure, from first incision to suture.
Measured: 24 hours
Complications
Number of intra and postoperative complications and what kind of complication it was.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start15 Nov 2022
- Primary completion15 May 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Principal Investigator: Bassel Traboulsi-Garet. Master of Oral Surgery and Implantology. University of Barcelona, Study Chair: Javier Bara-Casaus. Head of the Oral and Maxillofacial Surgery Institute. University Hospital Sagrat Cor, Barcelona., Study Chair: Eduard Valmaseda-Castellón. Full professor of Oral Surgery. University of Barcelona, Study Chair: Octavi Camps-Font. Lecturer in Oral Surgery. University of Barcelona, Study Director: Maria Angels Sanchez-Garces. Associate professor in Oral Surgery. University of Barcelona
- Responsible party
- Principal investigator, Adrià Jorba García, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155799
- Sponsor's protocol ID
- 11/2023
- Status last verified
- Dec 2023
- First submitted
- 21 Nov 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fan S, Saenz-Ravello G, Diaz L, Wu Y, Davo R, Wang F, Magic M, Al-Nawas B, Kammerer PW. The Accuracy of Zygomatic Implant Placement Assisted by Dynamic Computer-Aided Surgery: A Systematic Review and Meta-Analysis. J Clin Med. 2023 Aug 21;12(16):5418. doi: 10.3390/jcm12165418.
PubMed 37629460Kammerer PW, Fan S, Aparicio C, Bedrossian E, Davo R, Morton D, Raghoebar GM, Zarrine S, Al-Nawas B. Evaluation of surgical techniques in survival rate and complications of zygomatic implants for the rehabilitation of the atrophic edentulous maxilla: a systematic review. Int J Implant Dent. 2023 May 17;9(1):11. doi: 10.1186/s40729-023-00478-y.
PubMed 37198345Bhalerao A, Marimuthu M, Wahab A, Ayoub A. Dynamic navigation for zygomatic implant placement: A randomized clinical study comparing the flapless versus the conventional approach. J Dent. 2023 Mar;130:104436. doi: 10.1016/j.jdent.2023.104436. Epub 2023 Jan 31.
PubMed 36736529Tao BX, Wang F, Shen YH, Fan SQ, Huang W, Wang YP, Wu YQ. [Accuracy and clinical outcome of a real-time surgical navigation system for the placement of quad zygomatic implants]. Zhonghua Kou Qiang Yi Xue Za Zhi. 2020 Nov 9;55(11):845-850. doi: 10.3760/cma.j.cn112144-20200614-00343. Chinese.
PubMed 33171557Wu Y, Tao B, Lan K, Shen Y, Huang W, Wang F. Reliability and accuracy of dynamic navigation for zygomatic implant placement. Clin Oral Implants Res. 2022 Apr;33(4):362-376. doi: 10.1111/clr.13897. Epub 2022 Feb 15.
PubMed 35113463Tao B, Shen Y, Sun Y, Huang W, Wang F, Wu Y. Comparative accuracy of cone-beam CT and conventional multislice computed tomography for real-time navigation in zygomatic implant surgery. Clin Implant Dent Relat Res. 2020 Dec;22(6):747-755. doi: 10.1111/cid.12958. Epub 2020 Oct 28.
PubMed 33112508
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Dynamic Navigation System on Zygomatic Implant Placement: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06155799
- Acronym / sponsor ID
- 11/2023
- Conditions
- Dental Implants, Surgery, Computer-Assisted
- Keywords
- Surgery, Computer-Assisted, Dental implant, Navigation system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- Principal Investigator: Bassel Traboulsi-Garet. Master of Oral Surgery and Implantology. University of Barcelona, Study Chair: Javier Bara-Casaus. Head of the Oral and Maxillofacial Surgery Institute. University Hospital Sagrat Cor, Barcelona., Study Chair: Eduard Valmaseda-Castellón. Full professor of Oral Surgery. University of Barcelona, Study Chair: Octavi Camps-Font. Lecturer in Oral Surgery. University of Barcelona, Study Director: Maria Angels Sanchez-Garces. Associate professor in Oral Surgery. University of Barcelona
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 4 Dec 2023 (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 zygomatic implant placement in partially or total edentulous patients in the upper jaw compared with the conventional freehand method.
Detailed description
The present study is a prospective randomized clinical trial.
Each patient enrolled in this trial will be randomly allocated to on group (Navigation group (test group) or Freehand group (control group)). Preoperative virtual planification of zygomatic an conventional implants on a prerequired cone beam computed tomography (CBCT) with radiographic markers (tooth if possible or micro implants if not possible) will be performed for each patient.
The patient will be randomly allocated in one group just before the surgery, and the surgical procedure will be performed according the surgery protocol of each group. 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 European Conformity (CE) marked products and used within their intended use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navigation group | Experimental | Device: Freehand zygomatic implant placementZygomatic implant placement by dynamic computer assisted surgery system. |
| Freehand group | Active comparator | Device: Freehand zygomatic implant placementZygomatic implant placement by Freehand, without any guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Partial or total edentulous maxilla
- Large bone atrophy that avoids possible conventional implant placement
- Over 18 years old patients
Key exclusion criteria (2 listed)
- Patients with facial bone disease that contraindicates conventional or zygomatic implants placement.
- Systemic or local conditions that contraindicates oral surgery.
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 |
|---|---|---|
| Freehand zygomatic implant placementZygomatic implants will be placed without any guidance after preoperative virtual planning has been performed. | Device | Freehand group, Navigation group |
Primary outcome
Angular deviation
Time frame: 1 month
Angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees
Platform 3D deviation
Time frame: 1 month
Global deviation at the platform of the zygomatic 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: 1 month
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).
3 secondary outcomes
Patient-reported outcome measures questionnaire
Time frame: One week post operative
Time of surgery
Time frame: 24 hours
Complications
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Results publication: PubMed 37629460Fan S, Saenz-Ravello G, Diaz L, Wu Y, Davo R, Wang F, Magic M, Al-Nawas B, Kammerer PW. The Accuracy of Zygomatic Implant Placement Assisted by Dynamic Computer-Aided Surgery: A Systematic Review and Meta-Analysis. J Clin Med. 2023 Aug 21;12(16):5418. doi: 10.3390/jcm12165418.
- Results publication: PubMed 37198345Kammerer PW, Fan S, Aparicio C, Bedrossian E, Davo R, Morton D, Raghoebar GM, Zarrine S, Al-Nawas B. Evaluation of surgical techniques in survival rate and complications of zygomatic implants for the rehabilitation of the atrophic edentulous maxilla: a systematic review. Int J Implant Dent. 2023 May 17;9(1):11. doi: 10.1186/s40729-023-00478-y.
- Results publication: PubMed 36736529Bhalerao A, Marimuthu M, Wahab A, Ayoub A. Dynamic navigation for zygomatic implant placement: A randomized clinical study comparing the flapless versus the conventional approach. J Dent. 2023 Mar;130:104436. doi: 10.1016/j.jdent.2023.104436. Epub 2023 Jan 31.
- Results publication: PubMed 33171557Tao BX, Wang F, Shen YH, Fan SQ, Huang W, Wang YP, Wu YQ. [Accuracy and clinical outcome of a real-time surgical navigation system for the placement of quad zygomatic implants]. Zhonghua Kou Qiang Yi Xue Za Zhi. 2020 Nov 9;55(11):845-850. doi: 10.3760/cma.j.cn112144-20200614-00343. Chinese.
- Results publication: PubMed 35113463Wu Y, Tao B, Lan K, Shen Y, Huang W, Wang F. Reliability and accuracy of dynamic navigation for zygomatic implant placement. Clin Oral Implants Res. 2022 Apr;33(4):362-376. doi: 10.1111/clr.13897. Epub 2022 Feb 15.
- Results publication: PubMed 33112508Tao B, Shen Y, Sun Y, Huang W, Wang F, Wu Y. Comparative accuracy of cone-beam CT and conventional multislice computed tomography for real-time navigation in zygomatic implant surgery. Clin Implant Dent Relat Res. 2020 Dec;22(6):747-755. doi: 10.1111/cid.12958. Epub 2020 Oct 28.
- Related InfoLink provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freehand zygomatic implant placement in people with Dental Implants and Surgery, Computer-Assisted, 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 2 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 4 Dec 2023. 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 Bassel Traboulsi garet, DDS (616239499, basselt.121@gmail.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: 1 month). The study lists 3 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 NCT06155799, which also lists 6 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 4 Dec 2023.