New IMPLANTARY SURGERY Protocol ASSISTED BY PASSIVE ROBOTIQUE: Pilot Study (NAVIMPLANT)

The use of a passive robotic system allows the practitioner to widen the field of indications of flapless surgical access to the implant with an increased operative security and the possibility of an operative modification of the surgical protocol.

Study Overview

• Status: Recruiting
• Conditions: Dental Implants
• Intervention / Treatment: Procedure: Implant surgery assisted by passive robotics; Procedure: Conventional implant surgery

Detailed Description

In recent decades, the placement of dental implants has become a common procedure for the rehabilitation of partially or completely edentulous patients. The placement of implants requires good visibility of the bone support to avoid accidents such as bone fenestration. This is why, except in very favourable cases where the bone crest is wide, unconcavated and with an ideal periodontal support, it was until then necessary to proceed with a flap before placing the implant. This invasive surgical protocol necessary for implant placement with good visual access has negative parameters such as :

• detachment of the periosteum and therefore risk of bone resorption
• longer intervention time
• need for sutures
• post-operative pain. On the other hand, flapless techniques, which respect the periosteum and periodontium, offer simpler surgical outcomes, reduced risk of bleeding and infection, less bone resorption, and overall better healing. However, the absence of an access flap to the implant site requires special anatomical conditions to avoid any risk of bone fenestration during drilling, and this technique is directly related to the operator's experience. Increasing the number of cases treated by flap-free implant surgery with increased safety is now possible thanks to computer-assisted surgery and passive robotics.

The main objective is to compare the patient's post-operative pain outcomes between passive robotic implant surgery and conventional implant surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antoine GALIBOURG, MD; Phone Number: 05 61 77 36 10; Email: galibourg.a@chu-toulouse.fr
• Study Contact Backup: Name: Delphine COMTESSE MARET, MD; Email: comtesse-maret.d@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France
    • Recruiting
    • Toulouse University Hospital
    • Contact: Antoine GALIBOURG; Email: galibourg.a@chu-toulouse.fr
    • Contact: Delphine COMTESSE MARET; Email: comtesse-maret.d@chu-toulouse.fr
    • Sub-Investigator: Pierre BARTHET
    • Principal Investigator: Antoine GALIBOURG
    • Sub-Investigator: Laurent GINESTE
    • Sub-Investigator: Philippe CAMPAN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient at least 21 years old
• Favorable diagnosis of implant placement regardless of technique (ambivalence clause)
• Radiological situation with sufficient bone volume but requiring a muco-gingival flap or the help of passive robotics.
• Affiliated or beneficiary of a social security
• Signed informed consent

Exclusion Criteria:

• Patient eligible for one or more implants and having a broad bone crest, with no marked concavity, and covered with a sufficient amount of keratinized attached gum.
• Patient with limited oral opening
• Patient with contraindications to implant placement (valve prostheses, unbalanced diabetes)
• Photosensitive epileptic patient
• Patient refusal to participate in the study
• Pregnant or breastfeeding woman
• Patients under guardianship or curatorship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Passive robotic group; Implant surgery without flap assisted by passive robotics	Procedure: Implant surgery assisted by passive robotics; Implant surgery without flap assisted by passive robotics (X-Guide®)
Active Comparator: Control group; Implant surgery with flap	Procedure: Conventional implant surgery; Flap implant surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	Pain assessment according to a visual analogue scale ranging from 0 to 10	24 hours

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Antoine GALIBOURG, galibourg.a@chu-toulouse.fr

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: implantology; computer aided surgery; control navigation; X-Guide®
• Other Study ID Numbers: RC31/16/8764

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No