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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
dynamic navigation surgery
Procedure/Surgeryimmediate implant placement assisted by dynamic navigation
robotic surgery
Procedure/Surgeryimmediate implant placement assisted by robotic surgery
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
Surgery time
Time needed for surgery procedure will be recorded from anaesthesia to connection of cover screw/healing abutment.
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).
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).
Surgeon preference
Assessed using a visual analogue scale (VAS, 100 mm, with 0=least desirable option and 100 = most desirable option.
Sponsors and contacts
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