The Accuracy of Dental Implant Placement Using Robotic System-assisted Surgery and Freehand Surgery

Sponsor
Qi Yan (Other)
Overall Status
Recruiting
CT.gov ID
NCT06059573
Collaborator
(none)
28
1
2
2
14

Study Details

Study Description

Brief Summary

We plan to conduct this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of conventional freehand implant surgery. Patients will be enrolled and randomly assigned to either an experimental group that underwent robotic surgery or a control group that underwent freehand surgery, to evaluate the accuracy of implant in both groups.

Condition or Disease Intervention/Treatment Phase
  • Procedure: dental implant robot
  • Procedure: Freehand surgery
N/A

Detailed Description

Oral implants have become a widely used treatment modality for patients with missing or edentulous teeth. Previous studies have shown that implant accuracy is associated with implant success and long-term outcomes. Therefore, we plant to conduct this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of conventional freehand implant surgery. Patients will be enrolled and randomly assigned to either an experimental group that underwent robotic surgery or a control group that underwent freehand surgery. By comparing the preoperative planned implant position with the actual postoperative implant position using CBCT, we will evaluate the accuracy of implant in both groups.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Accuracy of Dental Implant Placement Using Robotic System-assisted Surgery and Freehand Surgery: a Randomized Clinical Trial
Anticipated Study Start Date :
Oct 7, 2023
Anticipated Primary Completion Date :
Nov 7, 2023
Anticipated Study Completion Date :
Dec 7, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Robot-guided

Implant placement by robot-guided based on a digital plan

Procedure: dental implant robot
Implant placement will be navigated by a dental implant robot based on a digital plan.

Active Comparator: Freehand surgery

Implant placement by freehand based on a digital plan

Procedure: Freehand surgery
Implant will be placed under freehand surgery.

Outcome Measures

Primary Outcome Measures

  1. Implant positional accuracy [immediately after surgery]

    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.

Secondary Outcome Measures

  1. Surgery complication [Immediately and seven days after surgery]

    Complication related to implant placement surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Single missing teeth with adjacent and opposing healthy natural teeth;

  2. Healthy patients;

  3. Sufficient alveolar bone available for implant placement.

Exclusion Criteria:
  1. Pregnancy or intention to become pregnant at any point during the study duration

  2. With any systemic diseases/conditions that are contraindications to dental implant...

Contacts and Locations

Locations

Site City State Country Postal Code
1 School & Hospital of Stomatology, Wuhan University Wuhan Hubei China 430070

Sponsors and Collaborators

  • Qi Yan

Investigators

  • Principal Investigator: Qi Yan, PhD, School & Hospital of Stomatology, Wuhan University
  • Study Chair: Yufeng Zhang, PhD, School & Hospital of Stomatology, Wuhan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qi Yan, associate professor, Hospital of Stomatology, Wuhan University
ClinicalTrials.gov Identifier:
NCT06059573
Other Study ID Numbers:
  • 2022[07]
First Posted:
Sep 28, 2023
Last Update Posted:
Sep 28, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Qi Yan, associate professor, Hospital of Stomatology, Wuhan University

Study Results

No Results Posted as of Sep 28, 2023