Clinical trial NCT05919862: Accuracy of Dental Implant Placement Using a Collaborative Surgery Robot
Official title: Three-dimensional Positional Accuracy of Dental Implant Placement Using a Haptic and Machine Vision Controlled Collaborative Surgery Robot: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dental Implant
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For free hand dental implant placement, a key difficulty is to accurately control the position. Improving precision of dental implant placement is considered important for safety and efficacy of tooth replacement with dental implants. The goal of this randomized controlled trial is to compare the positional implant accuracy, and patient reported outcomes comparing two methods of implant placement: the use of a robotic assisted surgery and freehand surgery. Patients requiring single tooth replacement with a dental implant will be digitally planned using a CBCT and an intraoral digital scan. Subjects will be randomized to one of the two treatment modalities based on the plan. The accuracy of placement will be assessed evaluating the difference between the planned and the actual position using a CBCT immediately after surgery. Subjects will be followed up for one year to assess both patient reported and professional outcomes.

Detailed description: For free hand dental implant placement, a key difficulty is to accurately control the position. Improving precision of dental implant placement is considered important for safety and efficacy of tooth replacement with dental implants. In particular, more precise implant placement is expected to yield a better restoration both in terms of aesthetics and ability for self-performed oral hygiene and thus prevention of peri-implant diseases. The goal of this randomized controlled trial is to compare the positional implant accuracy, and patient reported outcomes comparing two methods of implant placement: the use of a robotic assisted surgery and freehand surgery. Patients requiring single tooth replacement with a dental implant will be digitally planned using a CBCT and an intraoral digital scan. Subjects will be randomized to one of the two treatment modalities based on the plan. The accuracy of placement will be assessed evaluating the difference between the planned and the actual position using a CBCT immediately after surgery. Subjects will be followed up for one year to assess both patient reported and professional outcomes.

Eligibility criteria: Inclusion Criteria:

* Patient with a single missing tooth to be replaced with a dental implant
* With sufficient bone volume and keratinized tissue at edentulous site
* Willing to comply with research appointments/schedule.

Exclusion Criteria:

* Pregnancy or intention to become pregnant at any point during the study duration
* With any systemic diseases/conditions that are contraindications to dental implant treatment
* Inability or unwillingness of individual to give written informed consent
* Inability of follow-up according to the protocol.

Primary outcomes:
measure: Implant positional accuracy
timeFrame: Immediately after surgery
measure: Peri-implant soft tissue health
timeFrame: 12 month follow-up
Secondary outcomes:
measure: Local integrity of the alveolar bone
timeFrame: Immediately after surgery
measure: Discomfort perception
timeFrame: During surgery
measure: Pain perception
timeFrame: immediately after surgery, and 1 to 7 days after surgery
measure: Esthetics of the restoration
timeFrame: 12-months follow-up after delivery of crown
measure: Cytokine concentrations in PISF
timeFrame: 12-months follow-up after delivery of crown
measure: Submarginal microbiome
timeFrame: 12-months follow-up after delivery of crown
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Oral and Maxillofacial Implantology
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Tonetti Maurizio, PhD
role: PRINCIPAL_INVESTIGATOR
References: