Clinical trial NCT06250907: Accuracy of Implant Placement for Patients With Mandibular Reconstruction Using Dynamic Navigation and Static Guides
Official title: Evaluation of Accuracy of Implant Placement for Patients With Mandibular Reconstruction Using Dynamic Navigation Compared to Static Guides: a Parallel, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mandibular Deficiency
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* Patients with a history of full-dose radiotherapy, localized radiotherapy to the head or neck
* Patients requiring long-term high-dose steroid therapy
* Patients who are receiving or have received in the last 3 months medications (e.g., bisphosphonates) that may affect or promote bone metabolism
* Consecutive antibiotic therapy or chronic anti-inflammatory therapy (≥3 times per week) within the first 4 weeks of starting the procedure
* Alcohol or chronic substance abuse
* Immunocompromised patients
* Smoking/tobacco equivalents/chewing tobacco \>10 cigarettes per day
* Physical or mental impairment that interferes with the performance of oral hygiene care
* Female patients who are pregnant or breastfeeding
* Patients who, in the opinion of the investigator, have poor compliance and cannot participate in the trial
* Patients who have participated in a clinical trial of another drug or device within 30 days prior to the start of the procedure (Study Day 0)

Primary outcomes:
measure: Three-dimensional implant placement accuracy of apical point
timeFrame: Postoperative day 2±1
Secondary outcomes:
measure: Three-dimensional implant placement accuracy of coronal point
timeFrame: Postoperative day 2±1
measure: Three-dimensional implant placement angular accuracy
timeFrame: Postoperative day 2±1
measure: Operation time
timeFrame: Intraoperative
measure: Patient subjective satisfaction
timeFrame: Postoperative day 14±1
measure: Failure rate during implant healing period
timeFrame: Postoperative day 90±7
Other outcomes:
Locations:
Study officials:
References: