None listed
Conditions
Interventions
Medical Device : RAFUGENTM BMP2 DBM Gel(a graft material containing rhBMP2), Extraction area to a maximum of 1 cc injection, 1 times, Duration of efficacy observation (including pre-treatment period p
Sponsors
Cellumed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult patients (aged 20 to 70) who need to have their maxillomandibular anterior and premolar teeth (limited to single rooted tooth) extracted. (Bone grafting will be carried out on the wound of tooth extraction with RAFUGENTM BMP2 DBM Gel (a graft material containing rhBMP2) for the test group and RAFUGENTM DBM Gel (a graft material not containing rhBMP2) for the comparator group. 2) Patients whose bones surrounding the tooth at the target site of extraction and preservation (alveolar bones) procedures have been resorbed and decreased to 1/2 or less in a downward direction. 3) Patients who are strongly motivated for bone graft treatment. 4) Patients who have agreed to participate in the study and provided signed informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with serious periodontitis as in the case of those whose bones surrounding the tooth at the target site of extraction and preservation procedures (alveolar bones) have been resorbed and decreased to 1/2 or more in a downward direction, or patients with acute periodontitis although their alveolar bones have been resorbed and decreased to 1/2 or less in a downward direction. 2) Pregnant or lactating women, or women who are planning to become pregnant during the study and within 1 year after the study (women who do not agree to use contraception) or the elderly and infirm. 3) Patients with recent history of myocardial infarction attack. 4) Patients with uncontrolled bleeding diseases or other diseases that cannot allow minor operations. 5) Patients who have or are suspected of having mental diseases. 6) Patients with hypersensitivity reactions to bone graft materials. 7) Patients who are suspected of having insufficient liver function (AST/ALT = 2 X Upper Limit of Normal). 8) Patients with uncontrolled diabetes mellitus (Glucose> 200mg/dl). 9) Patients with history of alcohol or drug abuse. 10) Osteomyelitis or blood vessel damage at the site of operation. 11) Those excluded due to dental history (e.g., history of oral cancer, etc.). 12) Those on drugs that affect osteogenesis (e.g., steroids, bisphosphonates, etc.). 13) Smokers of 1/2 pack or more per day. 14) Renal disease or other systemic disease (uncontrolled diabetes mellitus, hyperthyroidism, abnormal bone metabolism, abnormal connective tissue metabolism, etc.). 15) Patients with HIV infection or those on immunosuppressants. 16) Inappropriate oral hygiene. 17) Administration of other investigational product within 30 days of study participation. 18) Patients, as judged by the principal investigator, who are not eligible for study participation due to ethical reasons or others that may affect the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline at the end of study (3 months after bone grafting) in the height of alveolar bone (buccal vertical bone);Change in the width of alveolar bone: the widths will be measured at 1mm, 3mm, and 5mm | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event, laboratory test(hematologic test/serum chemistry test, urinalysis) | — |
Countries
Korea, Republic of
Contacts
Public ContactKyoo Sung Cho
Yonseit University Health System, Dental Hospital
Outcome results
None listed