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An exploratory study on the treatment of patients with dentition loss using subperiosteal implants

Subperiosteal implants for dentition loss with severe jaw defect: a single-arm, exploratory study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106712
Enrollment
Unknown
Registered
2025-07-29
Start date
2025-03-04
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Tooth loss

Interventions

Test group:Subperiosteal implants

Sponsors

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18~80 years old (including 18 and 80 years old); 2. Require immediate restoration of implant dentures; 3. Alveolar bone atrophy in the edentulous area reaches grade IV~VIII (Cawood Howell classification), or severe jaw defect (height > 5mm and width >5mm due to trauma, tumor, dysplasia); 4. Volunteer to participate in the study, cooperate with the examination and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Obvious oral abscesses, precancerous lesions, fungal infections and wisdom tooth pericoronitis in the whole mouth; 2. Presence of any of the following cardiac clinical symptoms or diseases: History of myocardial infarction or heart failure within 6 months; resting state ECG examination finds important clinically significant abnormalities (such as abnormalities in heart rate, conduction, morphological characteristics, etc.) or complete left bundle branch block or third-degree heart block or second-degree heart block or PR interval > 250 ms; There are factors that increase the risk of QTc prolongation and abnormal heart rate, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or sudden unexplained death of an immediate family member under 40 years of age, or concomitant medication for prolonged QT interval. 3. Patients with cerebrovascular accident within 3 months; 4. Blood pressure on the day of surgery>=180/110mmHg; 5. Coagulation dysfunction, thrombocytopenia, hemophilia or significant anemia; 6. Glycated hemoglobin > 10%; 7. History of intravenous bisphosphonate use; 8. Those who use immunosuppressants; 9. Malignant tumors have not been treated standardly, or less than 5 years after standardized treatment; 10. Diagnosed with acquired immunodeficiency syndrome, syphilis, hepatitis B and hepatitis C without standardized treatment and control; 11. According to the investigator's judgment, the patient has other factors that may affect the results of the study or lead to the forced termination of this study, such as pregnancy, lactation, alcoholism, drug abuse, other serious diseases (including mental illness) that require combined treatment, serious laboratory test abnormalities, accompanied by family or social factors and other factors, which will affect the safety of the patient.

Design outcomes

Primary

MeasureTime frame
The incidence rates of loosening, fracture, exposure and detachment of titanium supports;

Secondary

MeasureTime frame
The subjective evaluation of the patient;The chewing efficiency of subperiosteal implant denture restoration;Local safety within one year after implant denture restoration;The incidence of implant complications within one year after implant denture restoration;The cross-sectional area of the bilateral temporal muscles one year after implant denture restoration;Systemic safety during the perioperative period;

Countries

China

Contacts

Public ContactDuohong Zou

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

zouduohongyy@163.com+86 13601645549

Outcome results

None listed

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