Evaluating the effect and stability of synthetic bone with Low Crystalline Apatite: A Prospective, Randomized Clinical Trial
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0009159
- Lead Sponsor
- Osstem Implant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 30
1.Patients over 19 years of age who has completed the skeletal growth
2.Those who need alveolar bone grafts in the area where the tooth extraction is scheduled or has been performed
3. Non-smoker or smoke less than one pack (20 cigarettes) per day
4.Patients who voluntarily decided to participate in this clinical trial and agreed to the consent form of the subject in writing.
1. a pregnant woman
2. People with uncontrolled systemic diseases that directly affect bone metabolism and healing (diabetes, osteomalacia, thyroid disease, etc.)
3. Those who have local lesions that may interfere with bone healing or lesions that may pose a threat to the future stability of the implant (a lesion with a high recurrence rate)
4. Those with localized mucosal lesions in the tooth defect or adjacent teeth and contralateral (e.g., erosive squamous lines)
5. Those who have been continuously given drugs that can affect bone metabolism for more than 7 days within 6 months (Bisphosphonates, Corticosteroids, etc.)
6. Those who have had radiation treatment on their heads or necks
7. A person who is immunocompromised by receiving immunosuppressants, anticancer drugs, etc
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Radiologic evaluation of implanted bone grafts : - CBCT analysis: CTs taken at the 2-week postoperative evaluation and CTs taken at the 16-week evaluation will be superimposed and the volume difference will be calculated.
- Secondary Outcome Measures
Name Time Method Histometric analysis;Patient Subjective Assessment: Pain Score (VAS);Infection after bone graft surgery