Accuracy of Dynamic Navigation and Static Template in Completely Edentulous Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Edentulous Jaw
• Intervention / Treatment: Device: Dynamic navigation; Device: Static template

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jinyan Chen; Phone Number: +86 15652440777; Email: 15652440777@163.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Ninth People's Hospital
    • Contact: Jinyan Chen; Phone Number: +86 15652440777

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dynamic navigation	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.
Active Comparator: Static template	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Operation time	From anaesthesia to all implants are placed	Surgery day
Implant stability quotient	Implant stability quotient was measured with the Osstell®device	Surgery day
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
Failure rate	Failure rate of implants during the healing period	About 4 months after surgery
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

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Investigators: Principal Investigator: Yiqun Wu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 3, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous
• Other Study ID Numbers: SDC-23-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No