Evaluation of Clinical efficacy of TissueMax : Multicenter Randomized Clinical Trial
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0002213
- Lead Sponsor
- Ewha Womans University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
1) Adult patients whose age is over 20 under 75 years of age and whose jaw growth has been completed
2) A patient who had two or more teeth missing in the upper and lower jaws, who underwent bone grafting and planned implant placement
3) Non-smoker
4) Patients who agreed to participate in the clinical trial and signed the patient consent form
1) Pregnant woman
2) Patients with metabolic disease (such as uncontrolled diabetes)
3) Patients taking medication that can affect bone metabolism - bisphosphonate, rhPTH, denosumab, etc
4) Patients with uncontrolled gingivitis, periodontitis, and dental caries
5) Patients who have undergone radiation therapy at the procedure site
6) Patients with hemorrhagic disease or needing anticoagulants
7) Patients with allergies to implant materials
8) Smoker
9) If the examiner determines that participation in the clinical trial is inadequate because it may affect other ethical or clinical trial results
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amount of Bone volume & Vertical height of alveolar bone;Amount of augmented tissue volume
- Secondary Outcome Measures
Name Time Method Width of Attached Gingiva;Width of Soft tissue ;MicroCT and Histological Analysis