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Navigation system contrast guide technology used to evaluate the accuracy of zygomatic implant placement: parallel, single-blind, randomized, controlled trial

Navigation system contrast guide technology used to evaluate the accuracy of zygomatic implant placement: parallel, single-blind, randomized, controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036370
Enrollment
Unknown
Registered
2020-08-22
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-07

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

Conditions

Dentition defect

Interventions

Group A:Test group (navigator)
Group B:Control group (guide plate)

Sponsors

The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged 18 to 70 years; 2. Maxillary edentulous or maxillary terminal dentition; 3. Maxillary hard tissue defects conform to Cawood & Howell classification IV-VI; 4. Normal mouth opening (>=40 mm); 5. Cheekbone width >=12mm; 6. Before implementing any research-related experimental procedures, the experimenter's resources should sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Local inflammation of adjacent teeth, including uncontrolled periodontitis (periodontal probing depth> 4mm); 2. Untreated acute and chronic apical periodontitis of adjacent teeth; 3. Oral mucosal lesions (such as lichen planus); 4. There are space-occupying lesions in adjacent teeth (including cysts, tumors, etc.); 5. System diseases that affect bone healing, wound healing and dental implant treatment (such as uncontrolled and stable diabetes, fasting blood glucose is still >=8.8mmol after drug control)/L); 6. Uncontrolled and stable severe hypertension; 7. Contraindications of conventional implant surgery and oral surgery; 8. Heart disease (heart function disease of grade II and above); 9. Patients with liver and kidney dysfunction or abnormalities; 10. Obese patients, body mass index BMI> 28 kg/m2; 11. Received full-dose radiotherapy, a history of local radiotherapy on the head or neck; 12. Patients requiring long-term high-dose steroid therapy; 13. Currently or nearly 3 Patients who have been treated with drugs (such as bisphosphonates) that may affect or promote bone metabolism within months; 14. Continuous antibiotic therapy or chronic anti-inflammatory therapy (>=3 times a week) within the first 4 weeks of starting surgery; 15. Alcoholism or long-term drug abuse; 16. Patients with immune insufficiency; 17. Smoking/tobacco equivalent/chewing tobacco more than 10 pieces a day; 18. Physical or mental defects affecting oral hygiene care; 19. Pregnant or breastfeeding Female patients; 20. Patients who the researcher believes that they have poor compliance and cannot participate in the trial; 21. The patients participated in the clinical trials of other drugs or devices within the first 30 days of starting the operation (study day 0).

Design outcomes

Primary

MeasureTime frame
Implant placement accuracy;

Secondary

MeasureTime frame
operation time;Patient satisfaction with surgery;Postoperative complications;Postoperative complications;

Countries

China

Contacts

Public ContactFeng Wang

The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

diana_wangfeng@aliyun.com+86 13651998106

Outcome results

None listed

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