None listed
Conditions
Interventions
Procedure/Surgery : - Total: 40 participants
- Experimental group (20 participants): Implant placement with Mega-Oss
- Control group (20 participants): Implant placement with Bio-Oss
20 participants
Sponsors
Yonsei University Health System, Dental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are adults aged 19 years or older with completed jaw growth. 2. Individuals with an appropriate level of oral hygiene for oral surgeries, including implant placement. 3. Individuals who experience a vertical bone defect of 1mm or more at the time of implant placement, requiring guided bone r egeneration. 4. Individuals who can understand and follow instructions and participate throughout the entire duration of the clinical trial. 5. Individuals who voluntarily decide to participate in this clinical trial and have provided written consent in the subject consent form.
Exclusion criteria
Exclusion criteria: 1. Severe smokers (those with a smoking habit of more than 20 cigarettes a day). 2. Individuals who have taken medications that interfere with bone formation (e.g., corticosteroids) within 2 weeks from the screening point or are likely to take them during the clinical trial. However, medications that do not significantly affect the efficacy of this study (such as oral steroids within 2-3 days post-surgery) are permissible. 3. Individuals who have received oral or injectable rheumatologic treatments, including immunosuppressants, within 2 weeks from the screening point. 4. Individuals with a history of hypersensitivity to Hydroxyapatite or De-mineralized bovine bone. 5. Patients with uncontrolled diabetes or hypertension, or those with blood coagulation disorders. 6. Patients with a history of radiation therapy or chemotherapy in the craniofacial region. 7. Individuals who have previously taken oral or injectable bisphosphonate osteoporosis treatments for more than 3 months or are currently undergoing such treatment (However, according to AOMS criteria, those who have stopped taking for more than 3 months and have a CTx level of 0.150 ng/ml or higher are eligible for clinical research). 8. Pregnant patients, those planning to become pregnant, or breastfeeding patients. 9. Individuals with alcohol or drug dependence. 10. Individuals with significantly poor oral hygiene management skills. 11. Additionally, individuals with clinically significant findings deemed inappropriate for this trial by the principal investigator or responsible personnel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the horizontal thickness of the peri-implant cortical bone on the surgical side immediately after surgery and 4 months later in computed tomography | — |
Secondary
| Measure | Time frame |
|---|---|
| Volumetric changes in peri-implant soft tissue through superimposition of intraoral scan images taken at different time points;Horizontal thickness of peri-implant soft tissue assessed by superimposition of intraoral scan images and computed tomography images;Assessment of patient satisfaction and operator-perceived difficulty using a visual analog scale (VAS) | — |
Countries
Korea, Republic of
Contacts
Public ContactPark Jin Yung
Yonsei University Health System, Dental Hospital
Outcome results
None listed