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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-07

Study Completion Date

2023-12-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dental Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Robot-guided

Implant placement by robot-guided based on a digital plan

Group Type EXPERIMENTAL

dental implant robot

Intervention Type PROCEDURE

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

Freehand surgery

Implant placement by freehand based on a digital plan

Group Type ACTIVE_COMPARATOR

Freehand surgery

Intervention Type PROCEDURE

Implant will be placed under freehand surgery.

Interventions

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dental implant robot

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

Intervention Type PROCEDURE

Freehand surgery

Implant will be placed under freehand surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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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...

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes