Assessment of the evaluating method for a spontaneous healing process at the extracted socket
- Conditions
- Patient whose dental extraction is planned
- Registration Number
- JPRN-UMIN000016561
- Lead Sponsor
- Osaka Dental University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1)Issues affecting evaluation of safety Patient: 1 with traumatic bone defect 2 whose surgical treatment (GBR, implant, etc) is planned in 24 weeks after the extraction, or has been done in 24 weeks before, in the same jaw where the extraction is planned 3 with untreated severe periodontal disease or caries (moderate or severe in adult periodontitis, or C4 grade in caries) 2)Issues affecting patient safety Patient: 1 who was regularly smoking till 24 weeks before the extraction, or will possibly smoke during the follow-up term 2 of diabetes not under control 3 who has had an irradiation record at head and neck region 4 with severe metabolic bone disease (osteoporosis, osteomalacia, rachitis, etc) 5 who took drugs affecting bone metabolism (bis-phosphonate, calcitonine, etc) 3)Issues affecting evaluation of efficacy Patient: 1 who has an implant adjacent to the extraction site 2 whose teeth adjacent to the extraction site has a metal nail (screw post) 3 whose teeth adjacent to the extraction site has a metal prosthesis fully covering the crown down to alveolar bone 4 having metal subjects that might cause artifact in CT image up to the same level as extracted alveolar bone 4)General consideration Patient: 1 who has a history of infection disease, or is in danger of it 2 in pregnancy or of possible pregnancy, or seeking pregnant, or during breast-feeding 3 who has a history of autoimmune diseases 4 in unstable or fatal in clinical condition (that might require urgent treatment) 5 with clinically serious organ disorder (heart failure of NYHA Class IV, arrhythmia such as ventricle tachycardia, fibrillation and flutter, adult respiratory distress syndrome, and for kidney, blood, metabolic/electrolyte abnormality and circulatory, in grade 3 defined in the 80th notification by MHW issued on June 29, 1992. 6 who was using a investigational device or drugs within one year before participating this study 7 who was judged disqualified as the subject by a principal investigator or sub-investigators
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method