Accuracy of Implant Placement for Patients With Mandibular Reconstruction Using Dynamic Navigation and Static Guides

NCT ID: NCT06250907

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2025-07-31

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.

Conditions

Mandibular Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dynamic navigation

Group Type: EXPERIMENTAL

The guidance of dynamic navigation

Intervention Type: PROCEDURE

Osteotomy and implant placement with the guidance of dynamic navigation

Static template

Group Type: ACTIVE_COMPARATOR

The guidance of static template

Intervention Type: PROCEDURE

Osteotomy and implant placement with the guidance of static template

Interventions

The guidance of dynamic navigation

Osteotomy and implant placement with the guidance of dynamic navigation

Intervention Type: PROCEDURE

The guidance of static template

Osteotomy and implant placement with the guidance of static template

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SDC-24-2

Identifier Type: -

Identifier Source: org_study_id