Accuracy of Dynamic Navigation System on Zygomatic Implant Placement

Dental Implants Clinical Trial

Official title:

Accuracy of Dynamic Navigation System on Zygomatic Implant Placement: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06155799
• Other study ID #: 11/2023
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: July 15, 2024

Study information

• Verified date: December 2023
• Source: University of Barcelona
• Contact: Bassel Traboulsi garet, DDS
• Phone: 616239499
• Email: basselt.121[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Dental Implants
• Surgery, Computer-Assisted

Intervention

Device:
• Freehand zygomatic implant placement
Zygomatic implants will be placed without any guidance after preoperative virtual planning has been performed.

Locations

Country	Name	City	State
Spain	Hospital Odontológic de Barcelona	L'Hospitalet De Llobregat	Barcelona

Sponsors (6)

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

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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

Outcome

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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