Multicenter and comparative clinical trial for assessing the new bone formation of domestic alloplastic grafts for peri-implant bone defects
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0006428
- Lead Sponsor
- Wonkwang University Daejeon Dental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
1. Over 20 years of age.
2. Presence of intrabony and buccal dehiscence defects after implant placement (=1 mm).
3. Proper oral hygiene and stable periodontal status which is suitable for implant surgery.
4. Having given their informed consent in accordance with IRB guidelines.
1. Current severe smokers (=20 cigarettes/day).
2. Taking medicines that interfere with bone formation within two weeks before screening.
3. Oral or injectable rheumatoid arthritis medication including immunosuppressants within 2 weeks before screening.
4. Oral or injectable bisphosphonate therapy for more than 3 months before screening.
5. History of hypersensitivity to hydroxyapatite or de-mineralized bovine bone.
6. Uncontrolled diabetes or hypertension.
7. Have received radiation therapy for head and neck cancers.
8. Pregnant or breastfeeding women.
9. Dependent on alcohol or drugs.
10. Poor oral hygiene and uncontrolled periodontal disease.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes of horizontal thickness of the augmented site
- Secondary Outcome Measures
Name Time Method Changes of defect width and height;Outcome of histologic assessments (newly formed bone area and residual bone graft biomaterial);Subjective postoperative discomfort ;Wound healing outcomes