Accuracy of Dynamic Navigation System on Zygomatic Implant Placement
NCT ID: NCT06155799
Last Updated: 2023-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
8 participants
INTERVENTIONAL
2022-11-15
2024-07-15
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Outcome assessor won't take part of the clinical process and will be blinded regarding which group is allocated each patient.
Study Groups
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Navigation group
Zygomatic implant placement by dynamic computer assisted surgery system.
Freehand zygomatic implant placement
Zygomatic implants will be placed without any guidance after preoperative virtual planning has been performed.
Freehand group
Zygomatic implant placement by Freehand, without any guidance.
Freehand zygomatic implant placement
Zygomatic implants will be placed without any guidance after preoperative virtual planning has been performed.
Interventions
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Freehand zygomatic implant placement
Zygomatic implants will be placed without any guidance after preoperative virtual planning has been performed.
Eligibility Criteria
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Inclusion Criteria
* Large bone atrophy that avoids possible conventional implant placement
* Over 18 years old patients
Exclusion Criteria
* Systemic or local conditions that contraindicates oral surgery.
18 Years
ALL
Yes
Sponsors
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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
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
University of Barcelona
OTHER
Responsible Party
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Adrià Jorba García
DDS
Locations
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Hospital Odontológic de Barcelona
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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BASSEL TRABOULSI GARET, DDS
Role: primary
References
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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.
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.
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.
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.
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.
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.
Related Links
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Other Identifiers
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11/2023
Identifier Type: -
Identifier Source: org_study_id