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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

a. General contraindications of oral implant surgery (such as immunodeficiency, long-term use of corticosteroids); 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • dynamic navigation surgery

    Procedure/Surgery

    immediate implant placement assisted by dynamic navigation

  • robotic surgery

    Procedure/Surgery

    immediate implant placement assisted by robotic surgery

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Robotic SurgeryExperimental treatment 1 intervention
Group B: Dynamic navigationSham comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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