Evaluation of Accuracy of Implant Placement for Patients With Mandibular Reconstruction Using Dynamic Navigation Compared to Static Guides: a Parallel, Randomized Controlled Clinical Trial

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University0 sites20 target enrollmentFebruary 29, 2024

ConditionsMandibular Deficiency

Overview

Phase: N/A
Intervention: Not specified
Conditions: Mandibular Deficiency
Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Enrollment: 20
Primary Endpoint: Three-dimensional implant placement accuracy of apical point
Status: Not Yet Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

To evaluate and compare the accuracy of implant placement using dynamic navigation technique versus static template technique in patients with bone tissue flap reconstruction of mandibular defects, thus further guiding the clinical application of dynamic navigation systems to assist in conventional implant placement in patients with mandibular defects.

Registry

clinicaltrials.gov

Start Date

February 29, 2024

End Date

July 31, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patients between the ages of 18 and 70 (inclusive)
•Mandibular defects (including Class I defects, limited to the body of the mandible; Class II defects, muscular-mandibular region defects and Class III defects, chin protrusion-muscular-mandibular region defects), which have been reconstructed by mandibular vascularization of free iliac bone, and fibular composite muscular flap grafts for greater than 3 months
•Normal mouth opening (≥ 40 mm)
•Trialists voluntarily signed an informed consent form before performing any research-related experimental steps.

Exclusion Criteria

•Presence of localized inflammation in adjacent teeth, including uncontrolled periodontitis (periodontal probing to a depth of \>4 mm)
•Presence of untreated acute and chronic apical periodontitis in adjacent teeth
•Oral mucosal lesions (e.g., lichen planus)
•Adjacent teeth with space-occupying lesions (including cysts, tumors, etc.)
•Systemic diseases affecting bone healing, wound healing and dental implant treatment (e.g., uncontrolled diabetes mellitus, fasting blood glucose ≥ 8.8 mmol/L despite medication)
•Uncontrolled and unstabilized severe hypertension
•Contraindications to routine implant surgery and oral surgery
•Heart disease (Class II or above)
•Patients with liver or kidney insufficiency or abnormality
•Obese patients with body mass index (BMI) \> 28 kg/m2

Outcomes

Primary Outcomes

Three-dimensional implant placement accuracy of apical point

Time Frame: Postoperative day 2±1

The postoperative cone beam computed tomography (CBCT) was aligned to the preoperative plan in specific software, and the three-dimensional coordinates of the preoperatively planned and actual postoperative implant placement positions were measured separately, from which the three-dimensional distance (in mm) between the apical point of the actual implant and the apical point of the virtual implant was calculated.

Secondary Outcomes

Failure rate during implant healing period(Postoperative day 90±7)
Three-dimensional implant placement angular accuracy(Postoperative day 2±1)
Operation time(Intraoperative)
Patient subjective satisfaction(Postoperative day 14±1)
Three-dimensional implant placement accuracy of coronal point(Postoperative day 2±1)