If there is bone defect after extraction of a single tooth or discontinuous multiple teeth (up to no more than two), and the maximum vertical bone wall defect does not exceed 50% of the expected implant length, guided bone regeneration and concurrent implant implantation are proposed
Conditions
Interventions
Control group:Received bone filling material (Bio-Oss) produced by Geistlich Pharma AG of Switzerland for guided bone regeneration and concurrent implant implantation
Experimental group:Received absorbable implant adhesives from Hangzhou Yuannang Biotechnology Co., Ltd. for guided bone regeneration and concurrent implant implantation
Sponsors
The Affiliated Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 and <=75 years, no gender restrictions; 2. After the extraction of a single tooth or non-adjacent multiple teeth (no more than 2 teeth), there is a bone defect with the vertical bone wall defect not exceeding 50% of the expected implant length, and guided bone regeneration with simultaneous implant placement is planned; 3. The target tooth must have at least 2mm of apical bone to ensure initial stability of the implant; 4. The participant or their guardian can understand the purpose of the study, show sufficient compliance with the study protocol, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with systemic infections or uncontrolled local infections, acute periapical infection of the target tooth, poor blood supply in the planned implant area, pathological changes in the local alveolar bone of the planned implant site, severe soft tissue lesions in the edentulous or adjacent area, uncontrolled periodontitis or pulp disease, limited mouth opening, malignant tumors, diagnosed severe malnutrition or failure of other major organs (heart, lungs, liver, kidneys); 2. Patients with uncontrolled endocrine disorders (such as severe, treatment-resistant diabetes, severe and uncontrolled parathyroid, adrenal, pituitary, or ovarian dysfunction); 3. History of myocardial infarction within 6 months before screening, or history of artificial heart valve surgery within 18 months before screening; 4. When the target tooth is a second molar and there is mesial third molar impaction; 5. Weekly use of oral or injectable sedatives or hypnotics, or non-steroidal anti-inflammatory drugs (except aspirin) within 3 months before screening;6. History of bisphosphonate injection; 7. Receiving chemotherapy or radiotherapy within 6 months before screening or during the screening period; 8. Oral or injectable corticosteroids, tetracyclines, or any growth factors taken for >=14 days within 1 month before screening or during the screening period; 9. Pregnant or breastfeeding women; 10. Participation in other clinical trials that may affect this study within 3 months before screening; 11. Other situations where the investigator, considering the subject’s best interest, deems it inappropriate for the subject to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of implantation 12 months after the operation;Immediate stability of the implant;Implant stability coefficient (ISQ);Vertical bone resorption volume;Changes in the average thickness of alveolar bone;Bone increment operation time;Incision healing condition;Evaluation of the operational performance of equipment;Incidence of adverse events;Incidence of device defects; | — |
Countries
China
Contacts
Public ContactLieping Sheng
The Affiliated Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Outcome results
None listed