Patient whose dental extraction is planned
Conditions
Interventions
None listed
Sponsors
Osaka Dental University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient: 1)whose extraction site is either one of between incisor and second premolar or mandibular third molars 2)with remaining dental root more than half at the extraction site 3)whose extracted socket would be possibly fulfilled with the bone 4)who has sufficient keratinized gingiva to cover the extracted socket 5)with a prior written consent 6)who is 20 years and older, and younger than 50 years at the time of consent 7)who can maintain a good oral hygiene condition during the follow-up term
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 The bone density ratio 2 Radiological evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Height of alveolar bone 2 Width of alveolar bone | — |
Countries
Japan
Contacts
Public ContactKenji Kakudo
Osaka Dental University Second Department of Oral and Maxillofacial Surgery
Outcome results
None listed