Tooth DiseasesNCT04999956
Accuracy and Primary Stability in Immediate Implant Placement: Dynamic Navigation Versus Freehand
A study testing dynamic navigation surgery and freehand surgery in people with Tooth Diseases, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 3 sites in China.
Trial summary
Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been reported better implant positioning. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Diseases
- What is being tested?
- dynamic navigation surgery and freehand surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2021to 31 Jul 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years old and in good health;
- The maxillary incisor that cannot be retained due to non-periodontitis;
- The buccal bone plate is complete;
- No acute infection;
- The extraction socket have at least 3-5 mm apical bone.
Who cannot join
- General contraindications of oral implant surgery (such as immunodeficiency, long-term use of corticosteroids);
- Treatments or diseases that may affect bone tissue metabolism (for example, taking bisphosphonates or receiving local radiotherapy);
- Periodontitis history or uncontrolled periodontitis. Bleeding of probing (BOP) positive site ≥ 10%, or probing depth (PD) ≥ 4mm;
- Heavy smokers or previous heavy smoking history (quit smoking time <5 years or> 20 cigarettes per day);
- Refuse to participate in this trial.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200011
Department of Oral and Maxillofacial Implantology
Shanghai, Shanghai Municipality, 200011
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, 200011
About this study
Official title: Accuracy and Primary Stability in Immediate Implant Placement Using Dynamic Navigation or Freehand
Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been reported better implant positioning. However, dynamic navigation's application to immediate implant placement has not been studied, and its exact role is still needed to be investigated further. Besides, implant insertion angle may influence primary stability, which is a prerequisite in achieving osseointegration, while dynamic navigation can precisely control angle and position. Therefore, the investigators designed a randomized controlled clinical trial study to verify the clinical efficacy of dynamic navigation and freehand in immediate implant placement. Patients will then be followed up one year after delivery of the crown to assess additional parameters.
Read the detailed description
Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been reported better implant positioning. However, dynamic navigation's application to immediate implant placement has not been studied, and its exact role is still needed to be investigated further. Besides, implant insertion angle may influence primary stability, which is a prerequisite in achieving osseointegration, while dynamic navigation can precisely control angle and position. Therefore, the investigators designed a randomized controlled clinical trial study to verify the clinical efficacy of dynamic navigation and freehand in immediate implant placement. Patients will then be followed up one year after delivery of the crown to assess additional parameters.
These will include the assessment of soft tissue inflammation, cytokine concentrations, microbiome, stability of the buccal bone plate.
- Conditions
- Tooth Diseases
- Being tested
- dynamic navigation surgery, freehand surgery
- Medical subject headings
- Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic navigation surgeryProcedure or surgery
immediate implant placement using dynamic navigation
freehand surgeryProcedure or surgery
immediate implant placement using freehand surgery
| Study group | Role | What they receive |
|---|---|---|
| dynamic navigation | Experimental | Dental implant placement using a dynamic navigation system Receives: Procedure: dynamic navigation surgery |
| freehand | Sham comparator | Dental implant placement using freehand technique Receives: Procedure: freehand surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
Taking cone-beam computed tomography (CBCT). The deviation between the planned implant and the actual implant were measured by Computer Assisted Dental Implant Precision System (Dcarer, Suzhou, China) as follows: (1) At least four feature points (like tooth cusps or bone pits) were selected in preoperative and postoperative CBCT for rough registration. (2) Feature surface circles in preoperative CBCT were selected, and then a mathematical algorithm displayed a similar feature surface circle in postoperative CBCT. The algorithm registered thousands of points in these two circles via conventional iso-surface thresholding technology. The software calculated registration error automatically. (3) Finally, the planned and actual implant were identified, and the deviation would be automatically calculated.
Measured: before surgery to after surgery one week
Peri-implant soft tissue health
Assessment of tissue health according to the definition of the 2017 International Classification. Berglundh et al.
Measured: 12-months follow-up after delivery of crown
Secondary outcomes (7)
Insetion torque value (ITV)
A general method to to detect primary stability roughly. The ITV were evaluated by a wrench (Straumann, Waldenburg, Switzerland) at the time of implant placement. The investigator record the number of scale. Being equal to or greater than 35N is a ideal primary stability.
Measured: surgery day
Implant Stability Quotient (ISQ)
A device to detect primary stability precisely. A Smartpeg was screwed into each implant, and resonance frequency analysis (RFA) was performed using Osstell Mentor (Osstell/Integration Diagnostics, Goteborg, Sweden). ISQ were recorded in the buccal and the palatal directions three times and averaged. <60 represents low stability; 60-70 represents medium stability; higher than 70 represents high stability.
Measured: surgery day
Esthetic appearance of the dental crown
PES-WES Score assessed using the Belser criteria
Measured: 12-months follow-up after delivery of the crown
Patient satisfaction
Assessed using a visual analogue scale (VAS=100mm, with 0=completely dissatisfied and 100 completely satisfied).
Measured: 12-months follow-up after delivery of crown
Peri-implant sulcus fluid Inflammation
Cytokine concentrations determined by multiplex ELISA
Measured: 12-months follow-up after delivery of crown
Buccal bone changes
Measurements performed on post-operative CBCT taken for routine follow-up
Measured: 12-months follow-up after delivery of crown
Implant microbiome
16S microbiome analysis performed on submarginal biofilm taken with a sterile paper point
Measured: 12-months follow-up after delivery of crown
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start1 Jan 2021
- Primary completion1 Dec 2021
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiseasesStudies of the same condition, open and under way.
- 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
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junyu Shi, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Junyu Shi, PhD, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999956
- Sponsor's protocol ID
- SH9H-2020-T122-2
- Status last verified
- Jun 2023
- First submitted
- 29 Jul 2021
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Primary Stability in Immediate Implant Placement Using Dynamic Navigation or Freehand
- ClinicalTrials.gov ID
- NCT04999956
- Acronym / sponsor ID
- SH9H-2020-T122-2
- Conditions
- Tooth Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 11 Aug 2021 (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.
Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been reported better implant positioning. However, dynamic navigation's application to immediate implant placement has not been studied, and its exact role is still needed to be investigated further. Besides, implant insertion angle may influence primary stability, which is a prerequisite in achieving osseointegration, while dynamic navigation can precisely control angle and position. Therefore, the investigators designed a randomized controlled clinical trial study to verify the clinical efficacy of dynamic navigation and freehand in immediate implant placement. Patients will then be followed up one year after delivery of the crown to assess additional parameters.
Detailed description
Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been reported better implant positioning. However, dynamic navigation's application to immediate implant placement has not been studied, and its exact role is still needed to be investigated further. Besides, implant insertion angle may influence primary stability, which is a prerequisite in achieving osseointegration, while dynamic navigation can precisely control angle and position. Therefore, the investigators designed a randomized controlled clinical trial study to verify the clinical efficacy of dynamic navigation and freehand in immediate implant placement. Patients will then be followed up one year after delivery of the crown to assess additional parameters.
These will include the assessment of soft tissue inflammation, cytokine concentrations, microbiome, stability of the buccal bone plate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dynamic navigation | Experimental | Procedure: dynamic navigation surgeryDental implant placement using a dynamic navigation system |
| freehand | Sham comparator | Procedure: freehand surgeryDental implant placement using freehand technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years old and in good health;
- The maxillary incisor that cannot be retained due to non-periodontitis;
- The buccal bone plate is complete;
- No acute infection;
- The extraction socket have at least 3-5 mm apical bone.
Key exclusion criteria (5 listed)
- General contraindications of oral implant surgery (such as immunodeficiency, long-term use of corticosteroids);
- Treatments or diseases that may affect bone tissue metabolism (for example, taking bisphosphonates or receiving local radiotherapy);
- Periodontitis history or uncontrolled periodontitis. Bleeding of probing (BOP) positive site ≥ 10%, or probing depth (PD) ≥ 4mm;
- Heavy smokers or previous heavy smoking history (quit smoking time <5 years or> 20 cigarettes per day);
- Refuse to participate in this trial.
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 navigation surgeryimmediate implant placement using dynamic navigation | Procedure or surgery | dynamic navigation |
| freehand surgeryimmediate implant placement using freehand surgery | Procedure or surgery | freehand |
Primary outcome
Accuracy
Time frame: before surgery to after surgery one week
Taking cone-beam computed tomography (CBCT). The deviation between the planned implant and the actual implant were measured by Computer Assisted Dental Implant Precision System (Dcarer, Suzhou, China) as follows: (1) At least four feature points (like tooth cusps or bone pits) were selected in preoperative and postoperative CBCT for rough registration. (2) Feature surface circles in preoperative CBCT were selected, and then a mathematical algorithm displayed a similar feature surface circle in postoperative CBCT. The algorithm registered thousands of points in these two circles via conventional iso-surface thresholding technology. The software calculated registration error automatically. (3) Finally, the planned and actual implant were identified, and the deviation would be automatically calculated.
Peri-implant soft tissue health
Time frame: 12-months follow-up after delivery of crown
Assessment of tissue health according to the definition of the 2017 International Classification. Berglundh et al.
7 secondary outcomes
Insetion torque value (ITV)
Time frame: surgery day
Implant Stability Quotient (ISQ)
Time frame: surgery day
Esthetic appearance of the dental crown
Time frame: 12-months follow-up after delivery of the crown
Patient satisfaction
Time frame: 12-months follow-up after delivery of crown
Peri-implant sulcus fluid Inflammation
Time frame: 12-months follow-up after delivery of crown
Buccal bone changes
Time frame: 12-months follow-up after delivery of crown
Implant microbiome
Time frame: 12-months follow-up after delivery of crown
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
Junyu Shi, PhD principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dynamic navigation surgery and freehand surgery in people with Tooth Diseases, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 3 sites 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 5 inclusion and 5 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 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
Accuracy (time frame: before surgery to after surgery one week). The study lists 2 primary outcomes in all. 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 18 Jun 2023.