Mandibular DeficiencyNCT06250907
Accuracy of Implant Placement for Patients With Mandibular Reconstruction Using Dynamic Navigation and Static Guides
A study testing The guidance of dynamic navigation and The guidance of static template in people with Mandibular Deficiency, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandibular Deficiency
- What is being tested?
- The guidance of dynamic navigation and The guidance of static template
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 29 Feb 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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)
About this study
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
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
- Being tested
- The guidance of dynamic navigation, The guidance of static template
- Medical subject headings
- Micrognathism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The guidance of dynamic navigationProcedure or surgery
Osteotomy and implant placement with the guidance of dynamic navigation
The guidance of static templateProcedure or surgery
Osteotomy and implant placement with the guidance of static template
| Study group | Role | What they receive |
|---|---|---|
| Dynamic navigation | Experimental | Not described Receives: Procedure: The guidance of dynamic navigation |
| Static template | Active comparator | Not described Receives: Procedure: The guidance of static template |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative day 2±1
Secondary outcomes (5)
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.
Measured: 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.
Measured: Postoperative day 2±1
Operation time
From the beginning of anesthesia to the complete removal of the static template or navigation reference frame.
Measured: Intraoperative
Patient subjective satisfaction
Evaluating patient satisfaction with the visual analogue scale
Measured: Postoperative day 14±1
Failure rate during implant healing period
- 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%.
Measured: Postoperative day 90±7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start29 Feb 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular DeficiencyStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250907
- Sponsor's protocol ID
- SDC-24-2
- Status last verified
- Nov 2023
- First submitted
- 1 Feb 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06250907
- Acronym / sponsor ID
- SDC-24-2
- Conditions
- Mandibular Deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 29 Feb 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic navigation | Experimental | Procedure: The guidance of dynamic navigation |
| Static template | Active comparator | Procedure: The guidance of static template |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The guidance of dynamic navigationOsteotomy and implant placement with the guidance of dynamic navigation | Procedure or surgery | Dynamic navigation |
| The guidance of static templateOsteotomy and implant placement with the guidance of static template | Procedure or surgery | Static template |
Primary outcome
Three-dimensional implant placement accuracy of apical point
Time frame: Postoperative day 2±1
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.
5 secondary outcomes
Three-dimensional implant placement accuracy of coronal point
Time frame: Postoperative day 2±1
Three-dimensional implant placement angular accuracy
Time frame: Postoperative day 2±1
Operation time
Time frame: Intraoperative
Patient subjective satisfaction
Time frame: Postoperative day 14±1
Failure rate during implant healing period
Time frame: Postoperative day 90±7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing The guidance of dynamic navigation and The guidance of static template in people with Mandibular Deficiency, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-dimensional implant placement accuracy of apical point (time frame: Postoperative day 2±1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.