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New IMPLANTARY SURGERY Protocol ASSISTED BY PASSIVE ROBOTIQUE: Pilot Study

New IMPLANTARY SURGERY Protocol ASSISTED BY PASSIVE ROBOTIQUE: Pilot Study

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05218941
Acronym
NAVIMPLANT
Enrollment
15
Registered
2022-02-01
Start date
2023-01-23
Completion date
2024-12-02
Last updated
2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implants

Keywords

implantology, computer aided surgery, control navigation, X-Guide®

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.

Interventions

PROCEDUREImplant surgery assisted by passive robotics

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

PROCEDUREConventional implant surgery

Flap implant surgery

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain assessment24 hoursPain assessment according to a visual analogue scale ranging from 0 to 10

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026