None listed
Conditions
Interventions
Medical Device : Transplant Bio-Oss and THE Graft on Maxillary sinus area using human mouth model. Make sure the patients do not know whether they belong to the experimental group or the controlled gr
Sponsors
Yonseit University Health System, Dental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age 19 or older 2) Need maxillary sinuses floor augmentation before implantation operation for single or multiple numbers of tooth 3) By result of panorama radiography and computed tomography, whose actual height of residual bone in lateral-posterior segment is 1mm < 6mm 4) Nonsmoking or smoking less than 10 cigarette for a day 5) Those who can understand and follow the instruction through the clinical trial period 6) Those who voluntarily participate to the trial and signed the agreement
Exclusion criteria
Exclusion criteria: 1)Those who has taken for has possibility to take medication that interfere bone formation within 2 weeks from the time of screening (e.g. Adrenocortical hormones, etc.) or throughout trial period. 2)Those who has taken oral or injectable rheumatism therapeutics including immunosuppressive within 2 weeks from the time of screening. 3)Who has hypersensitivity history with porcine bone and anorganic bovine bone 4)Patients with uncontrolled diabetes or hypertension or blood clotting tunes 5)Patients with a maxillary sinus or uncontrolled periodontal disease 6)Patients with intraoral skin disease or lesions (e.g. erosive lichen planus, erosive lichen planus, ulcer, malignant tumor, mouth ulcer, etc.) 7)Who has history of intraoral radiation therapy 8)Patients who has history of treatment with oral or injectable bisphosphonate base osteoporosis treatment more than 3 months or who is current under the treatment. (For exception that according to American Association of Oral and Maxillofacial Surgeons(AAOMS) standard, who stopped the treatment within 3 months and who has CTx level 0.150ng/ml can participate the clinical trial) 9)Among the control and experimental group, who is applicable of at least one of the following conditions A.Who has experience with bone graft and/or implantation B.Who has removed tumor C.Patients with osteomyelitis D.Patient with vascular diseases 10)Person who has significant clinical or radiological signs or symptoms in the maxillary that can affect the clinical trials 11)Alcoholic or who have lowered immune system 12)Person with severe bruxism or clenching habits 13)Person with lack of oral hygiene 14)Patient who is currently showing a clinical significant disorders in cardiovascular, digestive system, respiratory, endocrine and central nervous system or mental illness who can significantly impact on the clinical trial. 15)Person who participated to other clinical trial within 30 days from screening 16)Pregnant or lactating women 17)By the judge of test director or staff, person with clinical significant findings that are considered inappropriate other than conditions listed above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Newly formed bone area ratio;residual particle area | — |
Secondary
| Measure | Time frame |
|---|---|
| smoking, alcohol, any allergic reaction check;visual inspection for infection;implant placement, biopsies, visual inspection for infection;stitch out, visual inspection for infection, last validation | — |
Countries
Korea, Republic of
Contacts
Public ContactJung Seok Lee
Yonsei University
Outcome results
None listed