The specific disease or condition addressed in this study is maxillary edentulism (partial or complete tooth loss) accompanied by severe alveolar bone atrophy, specifically defined as Cawood-Howell classes IV to VI.Due to severe insufficient bone volume, these patients are not eligible for direct placement of conventional endosteal implants.They commonly present with loss of masticatory function,
Conditions
Interventions
Subperiosteal Implant Group:Personalized subperiosteal implant placement (without bone augmentation surgery)
Bone Grafting + Intraosseous Implant Group:Bone grafting surgery + intraosseous implant placement
Sponsors
Shanghai Ninth Peoples Hospital,Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
60 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Aged 60 to 90 years (including 60 and 90 years of age); 2. Require implant-supported dental prosthesis; 3. Partial or complete edentulism in the maxilla, with alveolar bone atrophy of the edentulous sites classified as Cawood–Howell Classes IV to VI; 4. Voluntarily participate in the study, cooperate with examinations, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Presence of obvious oral abscesses, precancerous lesions, fungal infections, and pericoronitis of wisdom teeth in the entire mouth; 2. Have any of the following cardiac clinical symptoms or diseases: History of myocardial infarction or heart failure attack within 6 months; Clinically significant abnormalities detected on resting electrocardiography (e.g., abnormalities in heart rate, conduction, morphological features), or complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, or PR interval > 250 ms; Presence of factors increasing the risk of QTc prolongation or heart rate abnormalities, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death of an immediate family member under 40 years of age, or concomitant use of QTc-prolonging medications; 3. Patients with a cerebrovascular accident within the past 3 months; 4. Blood pressure = 180/110 mmHg on the day of surgery; 5. Have coagulation disorders, thrombocytopenia, hemophilia, or significant anemia; 6. Glycated hemoglobin (HbA1c) > 10%; 7. History of intravenous bisphosphonate use, or history of radiotherapy in the surgical area; 8. Individuals using immunosuppressive agents; 9. Malignant tumor without standardized treatment, or less than 5 years after completion of standardized treatment; 10. Patients diagnosed with acquired immunodeficiency syndrome (AIDS), syphilis, hepatitis B, or hepatitis C who have not received standardized treatment and adequate control; 11. In the judgment of the investigator, the patient has other factors that may affect the study results or lead to premature termination of the study, such as pregnancy, lactation, alcohol abuse, substance abuse, other severe diseases (including psychiatric disorders) requiring concurrent treatment, severe abnormal laboratory test results, or family or social factors that may compromise the patient’s safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the survival rates of subperiosteal implants versus endosteal implants placed after bone augmentation surgery at 1 year following the completion of final prosthetic rehabilitation.; | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the masticatory efficiency of subperiosteal implants and endosteal implants at 1 year after the completion of final restoration.;To compare the local safety of subperiosteal implants and endosteal implants within 1 year after the completion of final restoration.;To compare the incidence of implant complications between subperiosteal implants and endosteal implants at 1 year after the completion of final restoration.;To compare the subjective patient evaluations of subperiosteal implants and endosteal implants at 1 year after the completion of final restoration using the Oral Health Impact Profile (OHIP).;To compare the systemic safety of subperiosteal implants and endosteal implants during the perioperative period of implant rehabilitation.; | — |
Countries
China
Contacts
Public ContactZou Duohong
Shanghai Ninth Peoples Hospital,Shanghai JiaoTong University School of Medicine
Outcome results
None listed