Clinical trial NCT06155799: Accuracy of Dynamic Navigation System on Zygomatic Implant Placement
Official title: Accuracy of Dynamic Navigation System on Zygomatic Implant Placement: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Implants
Surgery, Computer-Assisted
Keywords: Surgery, Computer-Assisted
Dental implant
Navigation system
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: Principal Investigator: Bassel Traboulsi-Garet. Master of Oral Surgery and Implantology. University of Barcelona
name: Study Chair: Javier Bara-Casaus. Head of the Oral and Maxillofacial Surgery Institute. University Hospital Sagrat Cor, Barcelona.
name: Study Chair: Eduard Valmaseda-Castellón. Full professor of Oral Surgery. University of Barcelona
name: Study Chair: Octavi Camps-Font. Lecturer in Oral Surgery. University of Barcelona
name: Study Director: Maria Angels Sanchez-Garces. Associate professor in Oral Surgery. University of Barcelona
First posted: 2023-12-04
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Angular deviation
timeFrame: 1 month
measure: Platform 3D deviation
timeFrame: 1 month
measure: Apex 3D deviation
timeFrame: 1 month
Secondary outcomes:
measure: Patient-reported outcome measures questionnaire
timeFrame: One week post operative
measure: Time of surgery
timeFrame: 24 hours
measure: Complications
timeFrame: 6 months
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Odontológic de Barcelona
state: Barcelona
Study officials:
References:
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: 10.3390/jcm12165418.
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 systematic review. Int J Implant Dent. 2023 May 17;9(1):11. doi: 10.1186/s40729-023-00478-y.
citation: 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.
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.j.cn112144-20200614-00343. Chinese.
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.
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.12958. Epub 2020 Oct 28.