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

NCT06250907 | Unknown

• 1 other identifier: SDC-24-2
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Three-dimensional implant placement accuracy of apical point

  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.

  Postoperative day 2±1

Secondary Outcomes (5)

• Three-dimensional implant placement accuracy of coronal point

  Postoperative day 2±1

• Three-dimensional implant placement angular accuracy

  Postoperative day 2±1

• Operation time

  Intraoperative

• Patient subjective satisfaction

  Postoperative day 14±1

• Failure rate during implant healing period

  Postoperative day 90±7

Study Arms (2)

Dynamic navigation

EXPERIMENTAL

Procedure: The guidance of dynamic navigation

Static template

ACTIVE COMPARATOR

Procedure: The guidance of static template

Interventions

The guidance of dynamic navigation PROCEDURE

Osteotomy and implant placement with the guidance of dynamic navigation

Dynamic navigation

The guidance of static template PROCEDURE

Osteotomy and implant placement with the guidance of static template

Static template

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

MeSH Terms

Conditions

Micrognathism

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: February 29, 2024
• Primary Completion: December 31, 2024
• Study Completion: July 31, 2025
• Last Updated: February 9, 2024

Record last verified: 2023-11