Accuracy of Dental Implant Placement Using a Collaborative Surgery Robot

Dental Implant Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05919862
• Other study ID #: SH9H-2023-05
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 16, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: September 2023
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: November 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implant

Intervention

Procedure:
• Robot system
Prosthetically guided Implant placement utilising robotic surgery based on a digital plan
• Freehand surgery
Freehand implant placement by experienced surgeon.

Locations

Country	Name	City	State
China	Department of Oral and Maxillofacial Implantology	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant positional accuracy	Implant accuracy will be measured as distance discrepancy at implant platform and implant apex, and angular discrepancy of implant axis between the digital plan and the actual position of the implant assessed digitally at the end of the procedure. Pre- and post-operative CBCT will be used for measurement.	Immediately after surgery
Primary	Peri-implant soft tissue health	Bleeding on probing and probing depth will be recorded, by probing gently around implant-supported restoration at six points: mesial-buccal, mid-buccal, distal-buccal, mesial-lingual, mid-lingual, and distal-lingual, using UNC-15 periodontal probe. This is defined according to the peri-implant health case definition by Berglundh et al 2017 and the ID-COSM international consensus conference	12 month follow-up
Secondary	Local integrity of the alveolar bone	The thickness of the buccal and lingual bone plates 1, 3, and 5 mm apical to the implant platform on post-surgery CBCT	Immediately after surgery
Secondary	Discomfort perception	Patient discomfort perception during surgery will be recorded using visual analogue scale (VAS with range from 0 to 10 with 10 being the highest possible pain experience)	During surgery
Secondary	Pain perception	Patient pain perception after surgery will be recorded using visual analogue scale (VAS with range from 0 to 10 with 10 being the highest possible pain experience) .	immediately after surgery, and 1 to 7 days after surgery
Secondary	Esthetics of the restoration	Assessed using the PES-WES scale as reported by Belser et al.with the scale ranging from 0 to 14 (worst to best)	12-months follow-up after delivery of crown
Secondary	Cytokine concentrations in PISF	Cytokine concentration in peri-implant sulcus fluid assesed by MULTIPLEX ELISA as concentrations of IL-1, TNF, IL-6 with lower concentrations reflecting less local inflammation	12-months follow-up after delivery of crown
Secondary	Submarginal microbiome	16S assessment of microbiome diversity (Shannon index) with greater diversity representing a more stable microbiome	12-months follow-up after delivery of crown