An interventional study of The guidance of dynamic navigation and The guidance of static template in Mandibular Deficiency, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Not yet recruiting. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Not applicable, Interventional, and Treatment
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.
26 studies on the registry are indexed under Micrognathism; 7 are open to participants now.
This study's planned enrollment of 20 is below the median of 24 across 22 interventional studies indexed under Micrognathism.
Browse Micrognathism studies →Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University is the lead sponsor of 164 studies on the registry; 73 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: The guidance of dynamic navigation
Procedure: The guidance of static template
Osteotomy and implant placement with the guidance of dynamic navigation
Osteotomy and implant placement with the guidance of static template
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.
Time frame: Postoperative day 2±1
Three-dimensional implant placement accuracy of coronal point
The postoperative 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 coronal point of the actual implant and the coronal point of the virtual implant was calculated.
Time frame: Postoperative day 2±1
Three-dimensional implant placement angular accuracy
The postoperative CBCT was aligned to the preoperative implant placement plan in specific software to measure the three-dimensional coordinates of the preoperative plan and the actual postoperative implant placement position, respectively, and to calculate the angle (°) between the actual implant and the mid-axis of the virtual implant accordingly.
Time frame: Postoperative day 2±1
Operation time
From the beginning of anesthesia to the complete removal of the static template or navigation reference frame.
Time frame: Intraoperative
Patient subjective satisfaction
Evaluating patient satisfaction with the visual analogue scale
Time frame: Postoperative day 14±1
Failure rate during implant healing period
1. According to the definition of Albrektsson and Zarb in 1986, the healing period is considered successful if the following conditions are met: no loosening of the implant after removal of the upper restoration; no peri-implant radiolucency; no peri-implant bone instability; and no pain. Implant retention was evaluated according to three levels: good osseointegration, poor osseointegration, and implant failure. 2. Implant survival rate = (N total - N failure)/(N total) × 100%.
Time frame: Postoperative day 90±7
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University →