None listed
Conditions
Interventions
Medical Device : 1. Test group
(1) Use: Osstem Implant TS-III, BA F 4.0mm, F 4.5mm, or F 5.0mm
- Select the appropriate one according to the patients alveolar bone width and height.
(2) How to use
-
implant surgery
2. Control group
(1) Use: Osstem Implant TS-III, SA F 4.0mm, F 4.5mm, or F 5.0mm
- Select the appropriate one according to the patients alveolar bone width and height.
(2) How to use
Sponsors
Seoul National University Dental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects eligible for surgical treatment 2. Subjects who need tooth extraction and implant restoration in the maxillary posterior region. 3. Subjects with 4 mm or more of the residual bone height in buccal area where the implant will be placed after tooth extraction. 4. Subjects without localized lesions such as a cyst. 5. Subjects who voluntarily agree to the clinical trial and are willing to comply with the study protocol
Exclusion criteria
Exclusion criteria: 1. Acute periodontal infection 2. When it is expected that it will be difficult to obtain a primary stability at the time of implant placement due to extensive bone loss (both buccal and palatal/lingual bone loss >50%) as a result of periodontal disease 3. Pregnant women or lactating woman 4. Subjects with uncontrolled hypertension or diabetes 5. Subjects with a history of radiation therapy and/or chemotherapy in the head and neck area 6. Subjects with serious cardiovascular disease, respiratory system disease, kidney disease, liver disease, digestive system disease, blood system disease and neuropsychiatric disease 7. Subjects with a history of drug allergy. 8. Subjects with a high degree of depressive or anxiety disorder which can affect clinical trial. 9. Subjects who have been in drug or alcohol abuse within 1 year 10. Subjects with a history of taking bisphosphonate drugs within 4 months. 11. Smokers who smoke more than one pack (20 cigarettes) per day. 12. Subjects whose occlusal stop is not being performed normally. 13. Cases where the researcher judged that the subject participation in the research is inappropriate because of other ethical or research results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| implant stability | — |
Secondary
| Measure | Time frame |
|---|---|
| Oral Health Impact Profile (OHIP-14);Modified sulcular bleeding index (mombelli, 1987);Modified plaque index (mombelli, 1987);Width of keratinized mucosa;implant mobility;probing;recession;Patient reported outcome measure;peri-implant marginal bone level ;peri-implant soft tissue volume | — |
Countries
Korea, Republic of
Contacts
Public ContactHyunyoung Song
Seoul National University Dental Hospital
Outcome results
None listed