Accuracy of Dynamic Navigation and Static Template in Completely Edentulous Patients
NCT ID: NCT06051266
Last Updated: 2023-09-22
Study Results
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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UNKNOWN
NA
58 participants
INTERVENTIONAL
2023-04-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dynamic navigation
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.
Static template
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
ALL
No
Sponsors
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Jinyan Chen
Role: primary
Other Identifiers
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SDC-23-2
Identifier Type: -
Identifier Source: org_study_id
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