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

  • STATUS
    Recruiting
  • End date
    Jul 22, 2024
  • participants needed
    84
  • sponsor
    University Hospital, Toulouse
Updated on 22 March 2022

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.

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.

Details
Condition Dental Implants
Treatment Implant surgery assisted by passive robotics, Conventional implant surgery
Clinical Study IdentifierNCT05218941
SponsorUniversity Hospital, Toulouse
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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