Accuracy of Dynamic Navigation System on Zygomatic Implant Placement

NCT06155799 | Unknown

• 1 other identifier: 11/2023
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Implants; Surgery, Computer-Assisted

Keywords

Surgery, Computer-Assisted; Dental implant; Navigation system

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Patient-reported outcome measures questionnaire

  One week post operative

• Time of surgery

  24 hours

• Complications

  6 months

Study Arms (2)

Navigation group

EXPERIMENTAL

Zygomatic implant placement by dynamic computer assisted surgery system.

Device: Freehand zygomatic implant placement

Freehand group

ACTIVE COMPARATOR

Zygomatic implant placement by Freehand, without any guidance.

Device: Freehand zygomatic implant placement

Interventions

Freehand zygomatic implant placement DEVICE

Zygomatic implants will be placed without any guidance after preoperative virtual planning has been performed.

Freehand group; Navigation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Partial or total edentulous maxilla
• Large bone atrophy that avoids possible conventional implant placement
• Over 18 years old patients

You may not qualify if:

• Patients with facial bone disease that contraindicates conventional or zygomatic implants placement.
• Systemic or local conditions that contraindicates oral surgery.

Sponsors & Collaborators

• University of Barcelona: lead
• Principal Investigator: Bassel Traboulsi-Garet. Master of Oral Surgery and Implantology. University of Barcelona: collaborator
• Study Chair: Javier Bara-Casaus. Head of the Oral and Maxillofacial Surgery Institute. University Hospital Sagrat Cor, Barcelona.: collaborator
• Study Chair: Eduard Valmaseda-Castellón. Full professor of Oral Surgery. University of Barcelona: collaborator
• Study Chair: Octavi Camps-Font. Lecturer in Oral Surgery. University of Barcelona: collaborator
• Study Director: Maria Angels Sanchez-Garces. Associate professor in Oral Surgery. University of Barcelona: collaborator

Study Sites (1)

Hospital Odontológic de Barcelona

L'Hospitalet de Llobregat, Barcelona, Spain

RECRUITING

Related Publications (6)

• 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.

  PMID: 37629460 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.

  PMID: 37198345 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.

  PMID: 36736529 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.

  PMID: 33171557 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.

  PMID: 35113463 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.

  PMID: 33112508 RESULT

Related Links

• Related Info

Central Study Contacts

Bassel Traboulsi garet, DDS

CONTACT

616239499; basselt.121@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 4, 2023
• Study Start: November 15, 2022
• Primary Completion: May 15, 2024
• Study Completion: July 15, 2024
• Last Updated: December 4, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)