Comparative Study of Efficacy and Safety of M-Bone (Biphasic Calcium Phosphate with Hydroxyapatite:Beta-tricalcium Phosphate of 70:30) versus Reference Commercial Product for Socket Preservatio
- Conditions
- Tooth socket preservationHydroxyapatite and Beta-tricalcium PhosphateBiphasic Calcium Phosphate
- Registration Number
- TCTR20200402006
- Lead Sponsor
- Assistive Technology and Medical Devices Research Center (A-MED)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 48
1. Subjects must be above 20 years of age and generally healthy.
2. Subjects who can tolerate local anesthetic injection
3. Subjects who are going to undergo extraction and subsequent implant placement due to periodontal disease, endodontic failure, advanced unrestorable caries, or tooth fracture. The indicated tooth should be bounded by adjacent teeth.
4. Subjects who agree to refrain from using medication that affect wound healing such as anti-angiogenic/anti-resorptive drugs after operation
5. Subjects who agree to refrain from using nonsteroidal anti-inflammatory drugs (NSAIDs) and antibiotics within 14 days after operation on Day 1 except that prescribed by investigator after operation.
6. Subjects who have the ability to understand the requirement of the study and must voluntarily sign and date an inform consent. If subjects are unable to read or may not fully understand the requirement of the study, such as elderly subjects, subject's legally acceptable representative (such as relatives), as witness should sign and date an inform consent.
1.Subjects who are known hypersensitivity to local anesthetic agents
2.Subjects with metabolic bone disease or any disease (from investigator's opinion) that may increase risk of subjects. This includes but not limit to uncontrolled hypertension, uncontrolled diabetic mellitus, severe hepatic impairment or end-stage renal failure.
3.Pregnancy or lactation subjects (by interviewing).
4.Subjects who have history of malignancy or radiotherapy or chemotherapy for malignancy in the past 5 years.
5.Subjects who have history of autoimmune disease, have long-term use of steroids or antibiotics, have any sign of any active infection or have any disease that in investigator's opinion has affect on the healing of wound.
6.Subjects with alcohol abuse or excessive use or alcoholism (in the opinion of the investigator, as judged by medical history)
7.Subjects who smoke more than 10 cigarettes per day
8.Subjects who are not able to follow instructions related to the study procedures.
9.Subjects who take anti-coagulant medication.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method %New bone formation 5 months post operation (bone grafting) micro-computed tomography (Micro-CT),dimensional change after socket preservation 0.5, 1.5, 3 and 5 months after operation (bone grafting) direct measurement, intraoral digital scanner and cone beam computed tomography (CBCT)
- Secondary Outcome Measures
Name Time Method safety (clinical laboratory results and inflammation rate - incidence of pus, infection and edema 0.5, 1.5, 3 and 5 months after operation (bone grafting) Direct observation