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| Name | Class |
|---|---|
| Principal Investigator: Bassel Traboulsi-Garet. Master of Oral Surgery and Implantology. University of Barcelona | UNKNOWN |
| Study Chair: Javier Bara-Casaus. Head of the Oral and Maxillofacial Surgery Institute. University Hospital Sagrat Cor, Barcelona. | UNKNOWN |
| Study Chair: Eduard Valmaseda-Castellón. Full professor of Oral Surgery. University of Barcelona |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navigation group | Experimental | Zygomatic implant placement by dynamic computer assisted surgery system. |
|
| Freehand group | Active Comparator | Zygomatic implant placement by Freehand, without any guidance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freehand zygomatic implant placement | Device | Zygomatic implants will be placed without any guidance after preoperative virtual planning has been performed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Angular deviation | Angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees | 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). | 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). | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One week post operative |
| Time of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bassel Traboulsi garet, DDS | Contact | 616239499 | basselt.121@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Odontológic de Barcelona | Recruiting | L'Hospitalet de Llobregat | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37629460 | Result | 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. | |
| 37198345 | Result | Kammerer 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| UNKNOWN |
| Study Chair: Octavi Camps-Font. Lecturer in Oral Surgery. University of Barcelona | UNKNOWN |
| Study Director: Maria Angels Sanchez-Garces. Associate professor in Oral Surgery. University of Barcelona | UNKNOWN |
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Patient will be unaware of which group since during the surgical procedure patient eyes' will be covered.
Outcome assessor won't take part of the clinical process and will be blinded regarding which group is allocated each patient.
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. |
| 24 hours |
| Complications | Number of intra and postoperative complications and what kind of complication it was. | 6 months |
| 36736529 | Result | Bhalerao 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. |
| 33171557 | Result | Tao 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. |
| 35113463 | Result | Wu 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. |
| 33112508 | Result | Tao 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. |