Clinical trial NCT04344808: Dynamic Navigation System in Implantology
Official title: Accuracy and Patient-Reported Outcome Measures (PROMs) of a Dynamic Navigation System in Implantology: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgery, Computer-Assisted
Dental Implants
Keywords: Surgery, Computer-Assisted
Dental Implants
Navigation system
Dynamic computer-assisted surgery
Implantology
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 30
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 dental implant placement in partially edentulous patients compared with the conventional freehand method.

Detailed description: This is a prospective randomized clinical trial.

Each patient enrolled in this trial will be randomly allocated to one group ( Navigation group or Freehand groups). Preoperative virtual planification of dental implants on a pre-acquired cone beam computed tomography (CBCT) will be performed for each patient using the same system.

During the surgical phase, depending on which group is allocated the patient one surgical approach or other will be used. 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 CE- (Conformité Européenne, meaning European Conformity) marked products and used within their intended use.

Eligibility criteria: Inclusion Criteria:

* Partially edentulous patients that requires at least the placement of one dental implant
* Healthy patients ASA I and II (American Society of Anesthesiologists classification)
* Over 18 years old patients

Exclusion Criteria:

* Totally edentulous patients
* Systemic or local conditions that contraindicates dental implant surgery
* Patients with less than 3 teeth in the jaw.

Primary outcomes:
measure: Angular deviation
timeFrame: 3 months post operative
measure: Platform 3D deviation
timeFrame: 3 months post operative
measure: Apex 3D deviation
timeFrame: 3 months post operative
measure: Platform 2D deviation
timeFrame: 3 months post operative
measure: Apex depth deviation
timeFrame: 3 months post operative
Secondary outcomes:
measure: Patient-reported outcome measures (PROMs) questionnaire
timeFrame: One week post operative.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Universitat de Barcelona
Study officials:
affiliation: University of Barcelona
name: Adrià Jorba-García
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Barcelona
name: Rui Figueiredo
role: STUDY_DIRECTOR
affiliation: University of Barcelona
name: Eduard Valmaseda-Castellón
role: STUDY_CHAIR
affiliation: University of Barcelona
name: Octavi Camps-Font
role: STUDY_CHAIR
affiliation: University of Barcelona
name: Javier Bara-Casaus
role: STUDY_CHAIR
References:
citation: Vercruyssen M, Fortin T, Widmann G, Jacobs R, Quirynen M. Different techniques of static/dynamic guided implant surgery: modalities and indications. Periodontol 2000. 2014 Oct;66(1):214-27. doi: 10.1111/prd.12056.
citation: Aydemir CA, Arisan V. Accuracy of dental implant placement via dynamic navigation or the freehand method: A split-mouth randomized controlled clinical trial. Clin Oral Implants Res. 2020 Mar;31(3):255-263. doi: 10.1111/clr.13563. Epub 2019 Dec 29.
citation: D'haese J, Ackhurst J, Wismeijer D, De Bruyn H, Tahmaseb A. Current state of the art of computer-guided implant surgery. Periodontol 2000. 2017 Feb;73(1):121-133. doi: 10.1111/prd.12175.
citation: Jorba-Garcia A, Figueiredo R, Gonzalez-Barnadas A, Camps-Font O, Valmaseda-Castellon E. Accuracy and the role of experience in dynamic computer guided dental implant surgery: An in-vitro study. Med Oral Patol Oral Cir Bucal. 2019 Jan 1;24(1):e76-e83. doi: 10.4317/medoral.22785.
citation: Block MS, Emery RW. Static or Dynamic Navigation for Implant Placement-Choosing the Method of Guidance. J Oral Maxillofac Surg. 2016 Feb;74(2):269-77. doi: 10.1016/j.joms.2015.09.022. Epub 2015 Sep 30.
citation: Emery RW, Merritt SA, Lank K, Gibbs JD. Accuracy of Dynamic Navigation for Dental Implant Placement-Model-Based Evaluation. J Oral Implantol. 2016 Oct;42(5):399-405. doi: 10.1563/aaid-joi-D-16-00025. Epub 2016 Jun 6.
citation: Jung RE, Schneider D, Ganeles J, Wismeijer D, Zwahlen M, Hammerle CH, Tahmaseb A. Computer technology applications in surgical implant dentistry: a systematic review. Int J Oral Maxillofac Implants. 2009;24 Suppl:92-109.