None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : This study compares two deproteinized bovine bone mineral xenografts for compromised socket preservation: test group (DB1) receives A-Oss® (Genoss Co., Ltd., Suwon,
Sponsors
Yonsei University Health System, Dental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients were eligible for inclusion if they met the following criteria: age 20-75 years; presence of single tooth requiring extraction due to severe chronic periodontitis (Stage III-IV according to 2017 AAP/EFP classification) or combined endodontic-periodontal lesion; extraction site with compromised socket walls as classified according to Koo et al. (2019) system (mild to severe buccal/lingual bone wall defects); adequate bone height (>10 mm from the crest to vital structures such as inferior alveolar nerve or maxillary sinus) and width (>5 mm bucco-lingual dimension) at the planned implant site after socket preservation; systemically healthy status with no contraindications for oral surgical procedures; willingness to comply with study protocol including 16-week healing period and core biopsy harvest at implant placement; ability to maintain adequate oral hygiene (plaque index <25%); and provision of written informed consent after full explanation of study procedures, risks, and benefits.
Exclusion criteria
Exclusion criteria: Patients were excluded from the study if they presented with: uncontrolled systemic diseases (diabetes mellitus with HbA1c >7%, uncontrolled hypertension, cardiovascular diseases requiring medication adjustment); immunosuppressive conditions or medications (corticosteroids, chemotherapy, immunosuppressants); metabolic bone diseases (osteoporosis, Paget's disease, hyperparathyroidism) or medications affecting bone metabolism (bisphosphonates, denosumab, high-dose corticosteroids); history of head and neck radiation therapy; active oral infection or acute periodontal abscess requiring immediate intervention; pregnancy or lactation; current smoking (>10 cigarettes/day) or history of heavy smoking within 6 months prior to enrollment; alcohol abuse or substance dependency; known allergy to bovine-derived products or collagen materials; previous bone grafting at the same site within 12 months; inability to undergo surgical procedures under local anesthesia; poor oral hygiene despite repeated instruction (plaque index persistently >25%); unwillingness to participate in follow-up examinations or comply with post-operative care instructions; or any condition that, in the investigator's judgment, would interfere with study participation or interpretation of results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of newly formed bone by histomorphometric analysis at 16 weeks post-grafting (non-inferiority evaluation at margins of -7%, -5%, -3.5%). | — |
Secondary
| Measure | Time frame |
|---|---|
| Residual graft and soft tissue percentages ;bone marrow and fibrous tissue;Bone Remodeling Efficiency;Implant Stability Changes;Relative Hounsfield Unit change (?HU) | — |
Countries
Korea, Republic of
Contacts
Public ContactHyunwoo Yang
Yonsei University Health System, Dental Hospital
Outcome results
None listed