Dental ImplantsNAVIMPLANTNCT05218941
New IMPLANTARY SURGERY Protocol ASSISTED BY PASSIVE ROBOTIQUE: Pilot Study
A study testing Implant surgery assisted by passive robotics and Conventional implant surgery in people with Dental Implants, run by University Hospital, Toulouse at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dental Implants
- What is being tested?
- Implant surgery assisted by passive robotics and Conventional implant surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2023to 2 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Dental Implants
- Being tested
- Implant surgery assisted by passive robotics, Conventional implant surgery
- Keywords
- implantology, computer aided surgery, control navigation, X-Guide®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant surgery assisted by passive roboticsProcedure or surgery
Implant surgery without flap assisted by passive robotics (X-Guide®)
Conventional implant surgeryProcedure or surgery
Flap implant surgery
| Study group | Role | What they receive |
|---|---|---|
| Passive robotic group | Experimental | Implant surgery without flap assisted by passive robotics Receives: Procedure: Implant surgery assisted by passive robotics |
| Control group | Active comparator | Implant surgery with flap Receives: Procedure: Conventional implant surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
Pain assessment according to a visual analogue scale ranging from 0 to 10
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start23 Jan 2023
- Primary completion2 Dec 2024
- Study completion2 Dec 2024
Why it stopped: Departure of the principal investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine GALIBOURG, Principal investigator, galibourg.a@chu-toulouse.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218941
- Sponsor's protocol ID
- RC31/16/8764
- Acronym
- NAVIMPLANT
- Status last verified
- May 2025
- First submitted
- 19 Jan 2022
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New IMPLANTARY SURGERY Protocol ASSISTED BY PASSIVE ROBOTIQUE: Pilot Study
- ClinicalTrials.gov ID
- NCT05218941
- Acronym / sponsor ID
- NAVIMPLANT / RC31/16/8764
- Conditions
- Dental Implants
- Keywords
- implantology, computer aided surgery, control navigation, X-Guide®
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Departure of the principal investigator
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive robotic group | Experimental | Procedure: Implant surgery assisted by passive roboticsImplant surgery without flap assisted by passive robotics |
| Control group | Active comparator | Procedure: Conventional implant surgeryImplant surgery with flap |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implant surgery assisted by passive roboticsImplant surgery without flap assisted by passive robotics (X-Guide®) | Procedure or surgery | Passive robotic group |
| Conventional implant surgeryFlap implant surgery | Procedure or surgery | Control group |
Primary outcome
Pain assessment
Time frame: 24 hours
Pain assessment according to a visual analogue scale ranging from 0 to 10
Results and safety
The study was stopped early (reason given: Departure of the principal investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine GALIBOURG principal investigator
galibourg.a@chu-toulouse.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant surgery assisted by passive robotics and Conventional implant surgery in people with Dental Implants, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Departure of the principal investigator). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.