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TerminatedNCT05218941NAVIMPLANTUpdated May 21, 2025

New IMPLANTARY SURGERY Protocol ASSISTED BY PASSIVE ROBOTIQUE: Pilot Study

An interventional study of Implant surgery assisted by passive robotics and Conventional implant surgery in Dental Implants, sponsored by University Hospital, Toulouse. Terminated at 1 site in France. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-05-21.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Treatment

Why this study was terminated
Departure of the principal investigator
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dental Implants

Keywords

  • implantology
  • computer aided surgery
  • control navigation
  • X-Guide®
03

In context

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Passive robotic group

    Implant surgery without flap assisted by passive robotics

    Procedure: Implant surgery assisted by passive robotics

  • Active comparator
    Control group

    Implant surgery with flap

    Procedure: 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

06

What researchers measure

Primary outcomes

  1. Pain assessment

    Pain assessment according to a visual analogue scale ranging from 0 to 10

    Time frame: 24 hours

07

Study locations

1 site
  • Toulouse University Hospital
    Toulouse, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05218941
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Feb 1, 2022
Start date
Jan 23, 2023
Primary completion
Dec 2, 2024
Completion
Dec 2, 2024
Last update
May 21, 2025

Study contacts

Antoine GALIBOURG
principal investigator · galibourg.a@chu-toulouse.fr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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