New IMPLANTARY SURGERY Protocol ASSISTED BY PASSIVE ROBOTIQUE: Pilot Study

NCT ID: NCT05218941

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-23
• Study Completion Date: 2024-12-02

Brief Summary

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.

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.

Conditions

Dental Implants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Passive robotic group

Implant surgery without flap assisted by passive robotics

Group Type: EXPERIMENTAL

Implant surgery assisted by passive robotics

Intervention Type: PROCEDURE

Implant surgery without flap assisted by passive robotics (X-Guide®)

Control group

Implant surgery with flap

Group Type: ACTIVE_COMPARATOR

Conventional implant surgery

Intervention Type: PROCEDURE

Flap implant surgery

Interventions

Implant surgery assisted by passive robotics

Implant surgery without flap assisted by passive robotics (X-Guide®)

Intervention Type: PROCEDURE

Conventional implant surgery

Flap implant surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoine GALIBOURG

Role: PRINCIPAL_INVESTIGATOR

galibourg.a@chu-toulouse.fr

Locations

Toulouse University Hospital

Toulouse, , France

Countries

France

Other Identifiers

RC31/16/8764

Identifier Type: -

Identifier Source: org_study_id