A pilot study to evaluate the safety and performance of PoroSyn, a synthetic bone graft, in a socket preservation procedure
- Conditions
- Health Condition 1: X- New Technology
- Registration Number
- CTRI/2021/04/032737
- Lead Sponsor
- SynThera Biomedical Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Need for tooth extraction
2. Subject aged between 18-45 years of age belonging to either sex
3. Non - smokers
4. Presence of healthy adjacent teeth to the tooth to be extracted
5. Medically fit and healthy patient, able to undergo oral surgical procedure under local anesthesia
6. Subjects with good oral hygiene
7.Able to sign Informed Consent
-Patients requiring extraction of third molars
-Acute infection or pus at the extraction site
-Habits (Smoking, tobacco/ Beetle nut chewing)
-Pregnant and lactating subjects
-Presence of active periodontal disease
-Subjects with poor oral hygiene and motivation
-Subjects addicted to drugs or alcohol
-Patients with psychiatric problem
-Patients with condition affecting bone
-Patients who are taking immunosuppressant medication
-Patients who are taking anti-coagulant medication
-Patients who have had or are undergoing radiation treatment of the graft region.
-Patients with uncontrolled systemic diseases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method