Accuracy of Dynamic Navigation and Static Template in Completely Edentulous Patients

Edentulous Jaw Clinical Trial

Official title:

Clinical Accuracy Evaluation of Dynamic Navigation and Static Template for Dental Implant Placement in Completely Edentulous Patients: A Randomized Parallel Controlled Multicenter Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06051266
• Other study ID #: SDC-23-2
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Jinyan Chen
• Phone: +86 15652440777
• Email: 15652440777[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Edentulous Jaw
• Jaw, Edentulous
• Mouth, Edentulous

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apical deviation of implant placement (mm)	Preoperative planning and postoperative cone-beam computed tomography (CBCT) were aligned together in the software and apical deviations(mm) of implant placement were measured to compare the results of the two groups.	About 3 days after surgery
Secondary	Coronal deviation of implant placement (mm)	Preoperative planning and postoperative CBCT were aligned together in the software and coronal deviations(mm) of implant placement were measured to compare the results of the two groups.	About 3 days after surgery
Secondary	Angular deviation of implant placement (°)	Preoperative planning and postoperative CBCT were aligned together in the software and angular deviations(°) of implant placement were measured to compare the results of the two groups.	About 3 days after surgery
Secondary	Operation time	From anaesthesia to all implants are placed	Surgery day
Secondary	Implant stability quotient	Implant stability quotient was measured with the Osstell®device	Surgery day
Secondary	visual analogue scale	Patients were asked how they felt about the procedure using a visual analogue scale (VAS), which was measured using a visual analogue scale from 0 to 10. On a scale of 0 to 10 ("no pain" 0 to "maximum pain" 10) ("very comfortable" 0 to "not at all comfortable" 10) ("no swelling" 0 to "severe swelling" 10)	About 3 days after surgery
Secondary	Failure rate	Failure rate of implants during the healing period	About 4 months after surgery
Secondary	Change of marginal bone level(mm)	Marginal bone level = Measurement of the distance (mm) between the reference point (shoulder of the implant) and the point of bone-implant contact on the periapical film ; Change of marginal bone level = marginal bone level in the follow-up period - marginal bone level in the baseline period (mm)	About 1 year after surgery