Clinical trial of Ossguide® for ridge preservation procedure
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0001708
- Lead Sponsor
- Bioland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
1. Healthy men and women over 20 years of age
2. Patients who are needed of least one or more tooth extractions in the maxillary or mandible
3. Patients who can respond in good faith on a regular recall until termination of clinical trial
4. Patients who fully understand the details of the trial and obtain a written consent
1. Patients with uncontrolled hypertension or diabetes
2. Patients with a history of malignancy or current diseases in the jaw
3. Patients with complications of serious cardiovascular disease, respiratory disease, heart disease, liver disease, digestive disorders, blood system diseases and neurological disorders•psychiatric disorders
4. Patients with hyperthyroidism or hypothyroidism
5. Patients with a history of drug allergy
6. Patients who have depression or anxiety disorder, and will influence the evaluation of efficacy
7. Patients with history of drug or alcohol abuse within a year or current abuse
8. Unlikely to be able to comply with study procedures according to Investigators judgement
9. Patients with allergic or hypersensitivity reactions to implant, bone graft material and barrier membrane
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absorption rate of implanted bone graft material using a Cone-beam CT;Volume measurements of hard and soft tissue around alveolar ridge using a Cone-beam CT;Adverse and inflammatory reactions
- Secondary Outcome Measures
Name Time Method Ease of handling ; VAS (Visual Analogue Scale)