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Multi center randomized controlled clinical study of dynamic surgical navigation system for the placement of implants in edentulous patient

Multi center clinical study of dynamic surgical navigation system for the placement of implants in edentulous patient

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035402
Enrollment
Unknown
Registered
2020-08-10
Start date
2020-11-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

Edentulous patients

Interventions

dynamic guided group:Dynamic navigation assisted implant placement
static guided group:Static guide plate assisted implant placement

Sponsors

Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Patients aged 18 to 65 years (including 18 and 65 years old) with male or female implants; 2) patients with severe periodontitis who need to be extracted; 3) patients with half mouth / full mouth missing dentition for more than 3 months, and the remaining bone mass can provide initial stability of the implant; 4) patients with severe alveolar ridge atrophy but sufficient zygomatic bone mass for zygomatic implant implantation; 5) subjects voluntarily signed informed consent before implementing any research related trial steps.

Exclusion criteria

Exclusion criteria: 1) Oral mucosal lesions (such as lichen planus); 2) oral space occupying lesions (including cysts, tumors, etc.); 3) systemic diseases affecting bone healing, wound healing and dental implant therapy (e.g., fasting blood glucose >= 8.8 mmol after drug control without control of stable diabetes mellitus); 4) uncontrolled severe hypertension; 5) contraindications for conventional implant surgery and oral surgery, including bone graft surgery; 6) heart disease (grade II and above heart function disease); 7) patients with liver and kidney dysfunction or abnormal; 8) obese patients with BMI > 28KG / M; 9) patients receiving full dose radiotherapy, local radiotherapy history of head or neck; 10) patients requiring long-term high-dose steroid therapy; 11) patients who are or have been treated with drugs (such as bisphosphonates) that may affect or promote bone metabolism in the past 3 months; 12) continuous use of antibiotics or chronic anti-inflammatory treatment (3 times a week) in the first 4 weeks before surgery; 13) alcoholism or long-term drug abuse; 14) patients with immune dysfunction; 15) smoking tobacco equivalent / chewing tobacco more than 10 cigarettes per day; 16) physical or mental defects affect oral health care; 17) patients who are allergic to products; 18) pregnant or lactating women; 19) patients who are considered by the researchers to be unable to participate in the trial due to poor compliance; 20) patients who participated in clinical trials of other drugs or devices within 30 days before the start of surgery (study day 0).

Design outcomes

Primary

MeasureTime frame
entry deviation of implant;apical deviation of implant;angle deviation of implant;operation time;intraoperational complication;Target registration error;Implant survival rate;

Secondary

MeasureTime frame
Postoperative complications;Patient's pain perception;

Countries

China

Contacts

Public ContactWu Yiqun

Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiaotong University School of Medicine

yiqunwu@outlook.com+86 13916892306

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026