ClinicalTrials.gg
Not yet recruitingNCT06895915Updated May 22, 2026

Accuracy of Immediate Implant Placement Using Robotic System Versus Dynamic Navigation System in Anterior Maxillae: A Random Controlled Clinical Trial

An interventional study of dynamic navigation surgery and robotic surgery in Tooth Diseases, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 in immediate implant placement compared to free hand procedure. On the basis of dynamic navigation, robotic system uses the robotic arm to replace the manual process of implant bed preparation and implant placement, therefore improving the accuracy of implant placement theoretically. The goal of this randomized controlled trial is to compare the positional implant accuracy, the surgical time, and patient satisfaction between dynamic navigation and robotic assisted immediate implant placement in maxillae. Subjects will be randomized to either group based on the allocation. The accuracy of placement will be assessed evaluating the difference between the planned and the actual position using a follow-up CBCT scan taken at the end of the surgery. Subjects will be followed up for one year to assess both patient reported and professional outcomes.

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 in immediate implant placement compared to free hand procedure. However, dynamic navigation faces the following deficiencies in immediate implant placement. Firstly, it has a steep learning curve. Secondly, the rigid palatal bone wall of the socket will force the direction of drill deviating buccally. On the basis of dynamic navigation, robotic system uses the robotic arm to replace the manual process of implant bed preparation and implant placement, therefore improving the accuracy of implant placement theoretically. The goal of this randomized controlled trial is to compare the positional implant accuracy, the surgical time, and patient satisfaction between dynamic navigation and robotic assisted immediate implant placement in maxillae. Subjects will be randomized to either treatment modalities based on the plan. The accuracy of placement will be assessed evaluating the difference between the planned and the actual position using a follow-up scan taken at the end of the surgery. Subjects will be followed up for one year to assess the professional outcomes.

02

Conditions studied

  • Tooth Diseases

Browse trials for

Keywords

  • immediate implant placement
  • dynamic navigation
  • robotic surgery
03

In context

Tooth Diseases

79 studies on the registry are indexed under Tooth Diseases; 11 are open to participants now.

This study's planned enrollment of 24 is below the median of 49 across 63 interventional studies indexed under Tooth Diseases.

Browse Tooth Diseases studies →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • a. ≥18 years old and in good health; b. One or more maxillary incisors that cannot be retained due to non-periodontitis; c. The buccal bone plate is intact; d. No acute infection; e. The extraction socket have at least 3-5 mm apical bone.

Exclusion criteria

Exclusion Criteria:

  • a. General of oral implant surgery (such as immunodeficiency, long-term use of ); b. Treatments or diseases that may affect bone tissue metabolism (for example, taking bisphosphonates or receiving local radiotherapy); c. Periodontitis history or uncontrolled periodontitis. Bleeding of probing (BOP) positive site ≥ 10%, or probing depth (PD) ≥ 4mm; d. Heavy smokers or previous heavy smoking history (quit smoking time \<5 years or> 20 cigarettes per day); e. Refuse to participate in this trial.
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Robotic Surgery

    Immediate implant placement assisted by robotic surgery

    Procedure: dynamic navigation surgery

  • Sham comparator
    Dynamic navigation

    Immediate implant placement assisted by dynamic navigation

    Procedure: robotic surgery

Interventions

  • Proceduredynamic navigation surgery

    immediate implant placement assisted by dynamic navigation

  • Procedurerobotic surgery

    immediate implant placement assisted by robotic surgery

06

What researchers measure

Primary outcomes

  1. Implant positional accuracy

    Implant accuracy will be measured as discrepancy between the digital plan and the actual position of the implant. (Global deviation at platform and apex, Angular deviation)

    Time frame: immediately after surgery

Secondary outcomes

  1. Surgery time

    Time needed for surgery procedure will be recorded from anaesthesia to connection of cover screw/healing abutment.

    Time frame: intraoperative

  2. Pain perception

    Patient pain perception during surgery will be recorded using visual analogue scale (VAS with range from 0 to 10 with 10 being the highest possible pain experience).

    Time frame: Immediately after surgery

  3. Pain perception

    Patient pain perception after surgery will be recorded using visual analogue scale (VAS with range from 0 to 10 with 10 being the highest possible pain experience).

    Time frame: 7 days after surgery

  4. Surgeon preference

    Assessed using a visual analogue scale (VAS, 100 mm, with 0=least desirable option and 100 = most desirable option.

    Time frame: Immediately after surgery

  5. Soft tissue changes

    Assessed by midfacial recession, mesial and distal papillary recession.

    Time frame: immediately after crown delivery

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results reported in this article, after de-identification, will be shared upon reasonable request to the corresponding author following publication.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: start date: 2026.12 end date: 2027.12

Access criteria: De-identified individual participant data and supporting study documents (including the study protocol and statistical analysis plan) will be available to qualified researchers upon reasonable request to the corresponding author after publication of the study results. Access will be granted for scientifically sound research purposes following review and approval of the research proposal. Data will be shared through secure electronic transfer.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06895915
Responsible party
shichong Qiao (Research Fellow, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University) — Principal investigator
First posted
Mar 26, 2025
Start date
Jun 1, 2026 (estimated)
Primary completion
Sep 1, 2026 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
May 22, 2026

Study contacts

Yijie Zhang, Master
Contact
izhangyijie@163.com
13524325673

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion