Accuracy of Dynamic Navigation and Static Template in Completely Edentulous Patients

Not Applicable

Recruiting

• Conditions: Edentulous Jaw
• Interventions: Device: Dynamic navigation; Device: Static template

• Registration Number: NCT06051266
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Status Verified: 2023-08
• Study First Submitted: 2023-09-03
• Study First Submitted QC: 2023-09-20
• Last Update Submitted: 2023-09-20
• Study First Posted: 2023-09-22
• Last Update Posted: 2023-09-22
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dynamic navigation	Dynamic navigation	-
Static template	Static template	-

Primary Outcome Measures

Name	Time	Method
Apical deviation of implant placement (mm)	About 3 days after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Change of marginal bone level(mm)	About 1 year after surgery	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)
Implant stability quotient	Surgery day	Implant stability quotient was measured with the Osstell®device
visual analogue scale	About 3 days after surgery	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)
Operation time	Surgery day	From anaesthesia to all implants are placed
Coronal deviation of implant placement (mm)	About 3 days after surgery	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.
Angular deviation of implant placement (°)	About 3 days after surgery	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.
Failure rate	About 4 months after surgery	Failure rate of implants during the healing period

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital; 🇨🇳 Shanghai, China