Dental Implants Clinical Trial
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.
Status | Recruiting |
Enrollment | 8 |
Est. completion date | July 15, 2024 |
Est. primary completion date | May 15, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Partial or total edentulous maxilla - Large bone atrophy that avoids possible conventional implant placement - Over 18 years old patients Exclusion Criteria: - Patients with facial bone disease that contraindicates conventional or zygomatic implants placement. - Systemic or local conditions that contraindicates oral surgery. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Odontológic de Barcelona | L'Hospitalet De Llobregat | Barcelona |
Lead Sponsor | Collaborator |
---|---|
University of Barcelona | Principal Investigator: Bassel Traboulsi-Garet. Master of Oral Surgery and Implantology. University of Barcelona, Study Chair: Eduard Valmaseda-Castellón. Full professor of Oral Surgery. University of Barcelona, Study Chair: Javier Bara-Casaus. Head of the Oral and Maxillofacial Surgery Institute. University Hospital Sagrat Cor, 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 |
Spain,
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 Ja — View Citation
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 — View Citation
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 sy — View Citation
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. — View Citation
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 — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Angular deviation | Angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees | 1 month | |
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | 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. | 24 hours | |
Secondary | Complications | Number of intra and postoperative complications and what kind of complication it was. | 6 months |
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