New IMPLANTARY SURGERY Protocol ASSISTED BY PASSIVE ROBOTIQUE: Pilot Study

Dental Implants Clinical Trial

— NAVIMPLANT  

Official title:

New IMPLANTARY SURGERY Protocol ASSISTED BY PASSIVE ROBOTIQUE: Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05218941
• Other study ID #: RC31/16/8764
• Status: Recruiting
• Phase: N/A
• Start date: December 2022
• Est. completion date: July 2024

Study information

• Verified date: August 2022
• Source: University Hospital, Toulouse
• Contact: Antoine GALIBOURG, MD
• Phone: 05 61 77 36 10
• Email: galibourg.a[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: July 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implants

Intervention

Procedure:
• Implant surgery assisted by passive robotics
Implant surgery without flap assisted by passive robotics (X-Guide®)
• Conventional implant surgery
Flap implant surgery

Locations

Country	Name	City	State
France	Toulouse University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment	Pain assessment according to a visual analogue scale ranging from 0 to 10	24 hours