UnknownNot Applicable

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

20 participantsStarted 2024-02-29

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Three-dimensional implant placement accuracy of apical point

Timeframe: Postoperative day 2±1

Trial details

NCT IDNCT06250907

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Mandibular Deficiency trials