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The Accuracy of Static Navigation Systems and Robotic System in Partially Edentulous in Posterior Area

NCT ID: NCT06173921

Last Updated: 2023-12-18

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2024-12-31

Brief Summary

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The aim of this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of static system-assisted implant surgery. Patients will be recruited and randomly assigned to either the robotic surgery group or the static navigation surgery group to evaluate the accuracy of the implants in both groups and to compare patient-reported and physician-reported outcomes of the two approaches.

Detailed Description

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Dental implants have been widely used for replacing the lost natural teeth, with evidence of long-term success and improvement of patients' quality of life. Nevertheless, proper implant position is considered today an essential prerequisite for ensuring successful treatment outcomes, as well as long-term maintenance of the prosthesis and the peri-implant tissue health.Therefore, we plan to conduct this randomized clinical trialto compare the implant positional accuracy of robotic system-assisted implant surgery with that of static system-assisted implant surgery. Patients will be recruited and randomly assigned to either the robotic surgery group or the static navigation surgery group to evaluate the accuracy of the implants in both groups and to compare patient-reported and physician-reported outcomes of the two approaches.

Conditions

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Dental Implant

Keywords

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Dental implant Robotic system Static navigation system

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Robotic system

implant placement by robotic surgery

Group Type EXPERIMENTAL

robotic system

Intervention Type PROCEDURE

Implant placement will be navigated by robotic system based on a digital plan

Static system

implant placement by static navigation surgery

Group Type ACTIVE_COMPARATOR

Static navigation system

Intervention Type PROCEDURE

Implant placement will be navigated by static navigation system based on a digital plan

Interventions

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robotic system

Implant placement will be navigated by robotic system based on a digital plan

Intervention Type PROCEDURE

Static navigation system

Implant placement will be navigated by static navigation system based on a digital plan

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Informed consent form signed voluntarily.
* Aged at least 18 years.
* Partial edentulousness in the posterior maxillary or mandibular region (premolar, molar, maximum two in a row).
* Sufficient bone volume for implant placement without bone augmentation;
* The minimum number of residual teeth was seven teeth.
* Good communication with the physician, compliance, ability to follow the physician's advice to maintain oral hygiene.

Exclusion Criteria

* Systemic disease that would interfere with dental implant surgery.
* Bisphosphonate treatment.
* Untreated, uncontrolled periodontal disease.
* Heavy smoker (more than 10 cigarettes per day).
* Poor oral hygiene.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ke Song

Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Zhilin Luo, MD

Role: CONTACT

Phone: 18667158923

Email: [email protected]

Other Identifiers

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TJ-IRB20231192

Identifier Type: -

Identifier Source: org_study_id