NCT05218941

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

January 23, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2024

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

January 19, 2022

Last Update Submit

May 16, 2025

Conditions

Dental Implants

Keywords

implantologycomputer aided surgerycontrol navigationX-Guide®

Outcome Measures

Primary Outcomes (1)

  • Pain assessment

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

    24 hours

Study Arms (2)

Passive robotic group

EXPERIMENTAL

Implant surgery without flap assisted by passive robotics

Procedure: Implant surgery assisted by passive robotics

Control group

ACTIVE COMPARATOR

Implant surgery with flap

Procedure: Conventional implant surgery

Interventions

Implant surgery assisted by passive roboticsPROCEDURE

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

Passive robotic group
Conventional implant surgeryPROCEDURE

Flap implant surgery

Control group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toulouse University Hospital

Toulouse, France

Location

Study Officials

  • Antoine GALIBOURG

    galibourg.a@chu-toulouse.fr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2022

First Posted

February 1, 2022

Study Start

January 23, 2023

Primary Completion

December 2, 2024

Study Completion

December 2, 2024

Last Updated

May 21, 2025

Record last verified: 2025-05

Locations

FR(1)