Accuracy of Dynamic Navigation and Static Template in Completely Edentulous Patients

NCT ID: NCT06051266

Last Updated: 2023-09-22

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

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-12-31

Brief Summary

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The study was a prospective, multicentre, randomized parallel controlled clinical trial. Randomisation was conducted by central randomisation, with random allocation codes generated by the main central computer. Enrollment was conducted by competition between different centres. In this study, the coronal, apical and angular deviations (mean, standard deviation, median, quartiles, minimum, maximum, 95% confidence interval) of the static template and dynamic navigation group guided implant placement were calculated. The data is proposed to be analysed using a mixed linear effects model.

Detailed Description

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Conditions

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Edentulous Jaw

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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Dynamic navigation

Group Type EXPERIMENTAL

Dynamic navigation

Intervention Type DEVICE

Dynamic navigation eliminates the need for a laboratory fabrication process and allows for direct visualisation of the operative area during implant placement. Moreover, it can avoid interfering with water cooling. Navigation-assisted surgery makes it possible to modify the implant system, length, diameter or position in real time, both in the perioperative period and during surgery.

Static template

Group Type ACTIVE_COMPARATOR

Static template

Intervention Type DEVICE

In most clinical situations, a static template can be used to assist in guiding the placement of implants precisely. The static guide has some limitations in that it requires additional fabrication time, has insufficient cooling in the surgical field and is not suitable for simultaneous grafting procedures.

Interventions

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Dynamic navigation

Dynamic navigation eliminates the need for a laboratory fabrication process and allows for direct visualisation of the operative area during implant placement. Moreover, it can avoid interfering with water cooling. Navigation-assisted surgery makes it possible to modify the implant system, length, diameter or position in real time, both in the perioperative period and during surgery.

Intervention Type DEVICE

Static template

In most clinical situations, a static template can be used to assist in guiding the placement of implants precisely. The static guide has some limitations in that it requires additional fabrication time, has insufficient cooling in the surgical field and is not suitable for simultaneous grafting procedures.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years old and above
* American society of anesthesiologists (ASA) Levels 1 and 2
* Satisfy any of the following requirements:

1. Edentulous maxillary patients
2. Edentulous mandibular patients
3. Terminally edentulous maxillary patients (number of remaining natural teeth in the upper jaw 1-4)
4. Terminally edentulous mandibular patients (number of remaining natural teeth in the lower jaw 1-4)
5. Full-mouth edentulous patients
6. Full-mouth terminally edentulous patients (number of remaining natural teeth in one jaw 1-4)
* Implant-supported fixed restorations or implant-supported overdenture restorations
* Sufficient usable bone volume at implant sites, non-implant sites (≥1.5mm of remaining bone width on the labial/buccal and palatal/lingual sides after virtual implant placement in software)
* Maxillary and mandibular options for full-mouth patients are based on the inclusion of more single jaws in the non-bone grafted sites (see virtual peri-implant bone volume requirements in the pre-operative preparation phase)
* Mouth opening of 3 fingers or more
* Single-jawed missing patients treated with systemic periodontal therapy

Exclusion Criteria

* Have a systemic disease that may affect prognosis (e.g. diabetic patients with glycated haemoglobin \>6.5%, patients on bisphosphonate medication, patients with auto-systemic immune diseases, etc.)
* ASA grades 3 and 4
* Acute inflammation in the oral cavity: including uncontrolled periodontitis (periodontal probing depth \> 4 mm) and untreated acute and chronic apical periodontitis
* Pregnancy or breastfeeding
* History of radiotherapy to the head and neck
* Heavy smokers (more than 10 cigarettes per day)
* Restricted mouth opening (less than three fingers).
* Participation in a clinical trial with another drug or device within 30 days prior to the start of the procedure (study day 0).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yiqun Wu

Role: PRINCIPAL_INVESTIGATOR

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Locations

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Shanghai Ninth People's Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jinyan Chen

Role: CONTACT

+86 15652440777

Facility Contacts

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Jinyan Chen

Role: primary

+86 15652440777

Other Identifiers

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SDC-23-2

Identifier Type: -

Identifier Source: org_study_id

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