Edentulous JawNCT06051266
Accuracy of Dynamic Navigation and Static Template in Completely Edentulous Patients
A study testing Dynamic navigation and Static template in people with Edentulous Jaw, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
The study was a prospective, multicentre, randomized parallel controlled clinical trial. Randomisation was conducted by central randomisation, with random allocation codes generated by the main central computer. Enrollment was conducted by competition between different centres. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- Dynamic navigation and Static template
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 31 Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 18 years old and above
- American society of anesthesiologists (ASA) Levels 1 and 2
- Satisfy any of the following requirements:
- Edentulous maxillary patients
- Edentulous mandibular patients
- Terminally edentulous maxillary patients (number of remaining natural teeth in the upper jaw 1-4)
Show all 14Show fewer
- Terminally edentulous mandibular patients (number of remaining natural teeth in the lower jaw 1-4)
- Full-mouth edentulous patients
- Full-mouth terminally edentulous patients (number of remaining natural teeth in one jaw 1-4)
- Implant-supported fixed restorations or implant-supported overdenture restorations
- Sufficient usable bone volume at implant sites, non-implant sites (≥1.5mm of remaining bone width on the labial/buccal and palatal/lingual sides after virtual implant placement in software)
- Maxillary and mandibular options for full-mouth patients are based on the inclusion of more single jaws in the non-bone grafted sites (see virtual peri-implant bone volume requirements in the pre-operative preparation phase)
- Mouth opening of 3 fingers or more
- Single-jawed missing patients treated with systemic periodontal therapy
Who cannot join
- Have a systemic disease that may affect prognosis (e.g. diabetic patients with glycated haemoglobin >6.5%, patients on bisphosphonate medication, patients with auto-systemic immune diseases, etc.)
- ASA grades 3 and 4
- Acute inflammation in the oral cavity: including uncontrolled periodontitis (periodontal probing depth > 4 mm) and untreated acute and chronic apical periodontitis
- Pregnancy or breastfeeding
- History of radiotherapy to the head and neck
- Heavy smokers (more than 10 cigarettes per day)
- Restricted mouth opening (less than three fingers).
- Participation in a clinical trial with another drug or device within 30 days prior to the start of the procedure (study day 0).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital
Shanghai
Jinyan Chen, +86 15652440777
About this study
Official title: Clinical Accuracy Evaluation of Dynamic Navigation and Static Template for Dental Implant Placement in Completely Edentulous Patients: A Randomized Parallel Controlled Multicenter Clinical Trial
The study was a prospective, multicentre, randomized parallel controlled clinical trial. Randomisation was conducted by central randomisation, with random allocation codes generated by the main central computer. Enrollment was conducted by competition between different centres. In this study, the coronal, apical and angular deviations (mean, standard deviation, median, quartiles, minimum, maximum, 95% confidence interval) of the static template and dynamic navigation group guided implant placement were calculated. The data is proposed to be analysed using a mixed linear effects model.
- Conditions
- Edentulous Jaw
- Being tested
- Dynamic navigation, Static template
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic navigationDevice
Dynamic navigation eliminates the need for a laboratory fabrication process and allows for direct visualisation of the operative area during implant placement. Moreover, it can avoid interfering with water cooling. Navigation-assisted surgery makes it possible to modify the implant system, length, diameter or position in real time, both in the perioperative period and during surgery.
Static templateDevice
In most clinical situations, a static template can be used to assist in guiding the placement of implants precisely. The static guide has some limitations in that it requires additional fabrication time, has insufficient cooling in the surgical field and is not suitable for simultaneous grafting procedures.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic navigation | Experimental | Not described Receives: Device: Dynamic navigation |
| Static template | Active comparator | Not described Receives: Device: Static template |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apical deviation of implant placement (mm)
Preoperative planning and postoperative cone-beam computed tomography (CBCT) were aligned together in the software and apical deviations(mm) of implant placement were measured to compare the results of the two groups.
Measured: About 3 days after surgery
Secondary outcomes (7)
Coronal deviation of implant placement (mm)
Preoperative planning and postoperative CBCT were aligned together in the software and coronal deviations(mm) of implant placement were measured to compare the results of the two groups.
Measured: About 3 days after surgery
Angular deviation of implant placement (°)
Preoperative planning and postoperative CBCT were aligned together in the software and angular deviations(°) of implant placement were measured to compare the results of the two groups.
Measured: About 3 days after surgery
Operation time
From anaesthesia to all implants are placed
Measured: Surgery day
Implant stability quotient
Implant stability quotient was measured with the Osstell®device
Measured: Surgery day
visual analogue scale
Patients were asked how they felt about the procedure using a visual analogue scale (VAS), which was measured using a visual analogue scale from 0 to 10. On a scale of 0 to 10 ("no pain" 0 to "maximum pain" 10) ("very comfortable" 0 to "not at all comfortable" 10) ("no swelling" 0 to "severe swelling" 10)
Measured: About 3 days after surgery
Failure rate
Failure rate of implants during the healing period
Measured: About 4 months after surgery
Change of marginal bone level(mm)
Marginal bone level = Measurement of the distance (mm) between the reference point (shoulder of the implant) and the point of bone-implant contact on the periapical film ; Change of marginal bone level = marginal bone level in the follow-up period - marginal bone level in the baseline period (mm)
Measured: About 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Apr 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yiqun Wu, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051266
- Sponsor's protocol ID
- SDC-23-2
- Status last verified
- Aug 2023
- First submitted
- 3 Sep 2023
- Last updated
- 22 Sep 2023
- 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 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Accuracy Evaluation of Dynamic Navigation and Static Template for Dental Implant Placement in Completely Edentulous Patients: A Randomized Parallel Controlled Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT06051266
- Acronym / sponsor ID
- SDC-23-2
- Conditions
- Edentulous Jaw
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Sep 2023 (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.
The study was a prospective, multicentre, randomized parallel controlled clinical trial. Randomisation was conducted by central randomisation, with random allocation codes generated by the main central computer. Enrollment was conducted by competition between different centres. In this study, the coronal, apical and angular deviations (mean, standard deviation, median, quartiles, minimum, maximum, 95% confidence interval) of the static template and dynamic navigation group guided implant placement were calculated. The data is proposed to be analysed using a mixed linear effects model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic navigation | Experimental | Device: Dynamic navigation |
| Static template | Active comparator | Device: Static template |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 18 years old and above
- American society of anesthesiologists (ASA) Levels 1 and 2
- Satisfy any of the following requirements:
- Implant-supported fixed restorations or implant-supported overdenture restorations
- Sufficient usable bone volume at implant sites, non-implant sites (≥1.5mm of remaining bone width on the labial/buccal and palatal/lingual sides after virtual implant placement in software)
Key exclusion criteria (8 listed)
- Have a systemic disease that may affect prognosis (e.g. diabetic patients with glycated haemoglobin >6.5%, patients on bisphosphonate medication, patients with auto-systemic immune diseases, etc.)
- ASA grades 3 and 4
- Acute inflammation in the oral cavity: including uncontrolled periodontitis (periodontal probing depth > 4 mm) and untreated acute and chronic apical periodontitis
- Pregnancy or breastfeeding
- History of radiotherapy to the head and neck
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 |
|---|---|---|
| Dynamic navigationDynamic navigation eliminates the need for a laboratory fabrication process and allows for direct visualisation of the operative area during implant placement. Moreover, it can avoid interfering with water cooling. Navigation-assisted surgery makes it possible to modify the implant system, length, diameter or position in real time, both in the perioperative period and during surgery. | Device | Dynamic navigation |
| Static templateIn most clinical situations, a static template can be used to assist in guiding the placement of implants precisely. The static guide has some limitations in that it requires additional fabrication time, has insufficient cooling in the surgical field and is not suitable for simultaneous grafting procedures. | Device | Static template |
Primary outcome
Apical deviation of implant placement (mm)
Time frame: About 3 days after surgery
Preoperative planning and postoperative cone-beam computed tomography (CBCT) were aligned together in the software and apical deviations(mm) of implant placement were measured to compare the results of the two groups.
7 secondary outcomes
Coronal deviation of implant placement (mm)
Time frame: About 3 days after surgery
Angular deviation of implant placement (°)
Time frame: About 3 days after surgery
Operation time
Time frame: Surgery day
Implant stability quotient
Time frame: Surgery day
visual analogue scale
Time frame: About 3 days after surgery
Failure rate
Time frame: About 4 months after surgery
Change of marginal bone level(mm)
Time frame: About 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
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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.
Yiqun Wu principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic navigation and Static template in people with Edentulous Jaw, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
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 14 inclusion and 8 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 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Jinyan Chen (+86 15652440777, 15652440777@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apical deviation of implant placement (mm) (time frame: About 3 days after surgery). 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 22 Sep 2023.