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A Multicenter Randomized Controlled Clinical Trial Comparing the Accuracy, Stability, and Safety of Four Implantation Protocols in Immediate Implant Placement for Maxillary and Mandibular Molars: Pre-extractive vs. Post-extractive Drilling with Handheld vs. Robotic Assistance

A Multicenter Randomized Controlled Clinical Trial Comparing the Accuracy, Stability, and Safety of Four Implantation Protocols in Immediate Implant Placement for Maxillary and Mandibular Molars: Pre-extractive vs. Post-extractive Drilling with Handheld vs. Robotic Assistance

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123355
Enrollment
Unknown
Registered
2026-04-24
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentition defect

Interventions

Conventional immediate implant group:Posterior immediate implant surgery
Robot-assisted immediate implant group:Robot-assisted implant surgery
Pre-extraction preparation immediate implant group:Pre-extraction alveolar preparation followed by posterior immediate implant surgery
Robot-assisted combined with pre-extraction preparation immediate implant group:Robot-assisted combined with pre-extraction alveolar preparation for posterior immediate implant surgery

Sponsors

Zhongshan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years, male or female, in good general condition, with no absolute contraindications to implant surgery (such as uncontrolled diabetes, coagulation disorders, immunocompromised status, etc.) 2. Maxillary or mandibular first/second molars that need to be extracted due to tooth fracture, untreatable pulp disease, or severe caries are eligible for immediate implantation. 3. The alveolar socket types are SI/SII/SIII (classified according to Bleyan et al. 2021): Mandibular molars must satisfy that the distance from the root bifurcation to the mandibular canal is >= 10 mm, and the distance from the root apex to the upper edge of the inferior alveolar canal is >= 5 mm; Maxillary molars must satisfy that the distance from the root apex to the floor of the maxillary sinus is >= 5 mm, without severe maxillary sinusitis. 4. The opening degree is >= 30 mm, and can cooperate with cross-center follow-up and imaging examinations. 5. Sign the informed consent form and be willing to complete the 12-month full follow-up.

Exclusion criteria

Exclusion criteria: 1. Root fusion deformity, active periapical periodontitis, jaw cysts, or acute infection at the implant site 2. Chronic smoking (>=10 cigarettes per day), bruxism, severe periodontal disease (full-mouth periodontal pocket depth >=6 mm) 3. Pregnant or lactating women, or those taking drugs that affect bone metabolism 4. The implant site has undergone jawbone surgery, radiotherapy, or chemotherapy 5. Mental illness, cognitive impairment, or language communication disorder, unable to cooperate with treatment and follow-up 6. Participants in other concurrent oral clinical trials

Design outcomes

Primary

MeasureTime frame
Implant angular deviation;

Secondary

MeasureTime frame
Implant position coronal deviation and apical deviation;

Countries

China

Contacts

Public ContactSun Jian

Zhongshan Hospital Affiliated to Fudan University

sun.jian@zs-hospital.sh.cn+86 21 6404 1990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026