Single-tooth loss
Conditions
Interventions
Research Group:Oral Repair Membrane(Shanghai Divine Medical Technology Co ., Ltd)+Bio-oss+ITI dental implant System
Control Group:Bioresorbable Matrix Barrier(Sunstar Americas Inc.)+Bio-oss+ITI dental implant System
Sponsors
The Third Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Patients aged between 18 and 65 years (inclusive), regardless of gender; 2.Individuals requiring implant restoration for single-tooth loss at non-free end sites; 3.Insufficient horizontal bone width at the buccal aspect of the restoration site, but capable of providing primary implant stability or alveolar bone width >=3 mm; 4.Keratinized gingiva from the alveolar ridge crest midline to the mucogingival junction >=2 mm; 5.Alveolar ridge capable of safely accommodating an implant >=8 mm in length or alveolar ridge height =5 mm; 6.Voluntary participation in this clinical trial with the signed informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with uncontrolled periodontitis in adjacent teeth to the surgical site; 2.Patients with unresolved acute/chronic periapical periodontitis in adjacent teeth to the surgical site; 3. Oral mucosal lesions (e.g., lichen planus, leukoplakia); 4.Patients with space-occupying lesions in adjacent teeth (including cysts, tumor); 5.Systemic diseases that may impair postoperative healing or osseointegration (e.g., poorly controlled diabetes with fasting blood glucose >=8.8 mmol/L despite medication, osteoporosis, HIV infection); 6.Patients with active infectious diseases (hepatitis B/C, syphilis, HIV/AIDS); 7.Cardiovascular diseases (New York Heart Association [NYHA] Class II or higher cardiac dysfunction); 8. Severe hepatic/renal impairment (AST/ALT >=2.5×ULN); 9.History of head/neck radiotherapy or chemotherapy, or ongoing radiation therapy; 10.Current or chronic use of medications affecting healing/bone metabolism (e.g., bisphosphonates, calcitonin, menopausal hormone therapy); 11.Substance abuse (drugs/alcohol) or tobacco use (>10 cigarettes/equivalents per day); 12.Medically compromised patients or those with mental incapacitation; 13.Hypersensitivity history (e.g., to polylactic acid, metals); 14.Pregnancy, lactation, or planned pregnancy within 1 year; 15.Current participation in other drug/device clinical trials; 16.Patients deemed ineligible by investigator judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of horizontal buccal bone plate bone growth effects between two patient groups.Horizontal alveolar bone growth at 2 mm below the implant abutment at 6 months post-surgery.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of horizontal buccal bone plate bone growth effects between two patient groups.Horizontal alveolar bone growth at 0 mm,4 mm,6 mm below the implant abutment at 6 months post-surgery.;Postoperative 6-month osseointegration status;Wound healing status at 10 (±4) days and 3 months postoperatively;Implant stability at 6 months postoperatively; | — |
Countries
China
Contacts
Public ContactNiu Lina
The Third Affiliated Hospital of Air Force Medical University
Outcome results
None listed