None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : 1. Test Group (n=15):
Intervention: 'Simplified GBR' procedure using block-type collagenated xenograft (LEGO Graft) alone.
Details: Bone regeneration is induced by
Sponsors
Yonsei University Health System, Dental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Adults aged 19 years or older ? Patients expected to require guided bone regeneration (GBR) due to confirmed horizontal buccal bone defects at the planned implant placement site
Exclusion criteria
Exclusion criteria: ? Patients requiring GBR in extensive defect areas where three or more implants must be placed simultaneously. ? Patients with uncontrolled periodontal disease. ? Patients with systemic metabolic diseases, such as uncontrolled diabetes. ? Heavy smokers (more than 20 cigarettes per day) or those who smoke pipes or cigars. ? Patients with a history of head and neck radiation therapy or chemotherapy. ? Pregnant or breastfeeding patients. ? Patients with a history of taking bisphosphonates within the last four months. ? Patients with poor oral hygiene (Full-mouth plaque score = 25%).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hard tissue dimensional changes, including horizontal bone width, augmented area, and volume, measured by superimposing CBCT(Cone Beam Computed Tomography) scans at baseline, immediate post-op, and 4 months post-op. | — |
Secondary
| Measure | Time frame |
|---|---|
| Early wound healing index (EHI) evaluated through clinical photographs at the time of suture removal.;Clinician-reported outcomes (CRO) including operability, stability, and overall satisfaction evaluated via questionnaires.;Patient-reported outcomes (PRO) for postoperative pain and discomfort assessed via questionnaires. | — |
Countries
Korea, Republic of
Contacts
Public ContactJung-Seok Lee
Yonsei University
Outcome results
None listed