Dynamic Navigation System in Implantology

University of Barcelona

Status: Unknown

Conditions: Dental Implants; Surgery, Computer-Assisted

Treatments: Device: Dynamic navigation system; Device: Freehand implant placement

Study type: Interventional

Funder types: Other

Identifiers

NCT04344808

NavigationSystem

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Navigation group

Experimental group

Description:

Dental implants will be placed using a dynamic computer assisted surgery system

Treatment:

Device: Dynamic navigation system

Freehand group

Active Comparator group

Description:

Dental implants will be place without any guidance. Only virtually planning the ideal position on a 3D image (Cone beam computed tomography)

Treatment:

Device: Freehand implant placement