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

Toulouse University Hospital

Status: Terminated

Conditions: Dental Implants

Treatments: Procedure: Implant surgery assisted by passive robotics; Procedure: Conventional implant surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05218941

RC31/16/8764

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Passive robotic group

Experimental group

Description:

Implant surgery without flap assisted by passive robotics

Treatment:

Procedure: Implant surgery assisted by passive robotics

Control group

Active Comparator group

Description:

Implant surgery with flap

Treatment:

Procedure: Conventional implant surgery