Status:
UNKNOWN
A Phase I Study of SB Cell for the Enhanced Osseointegration of Guided Bone Regeneration in Implant Surgery
Lead Sponsor:
Taipei Medical University
Conditions:
Guided Bone Regeneration
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
This is a Phase 1 study to evaluate the safety profile of autologous-derived SB cells to enhance osseointegration of GBR in patients undergoing dental implant surgery.
Detailed Description
This is a Phase 1 study to evaluate the safety profile of autologous-derived SB cells to enhance osseointegration of GBR in patients undergoing dental implant surgery. Enrolled subjects eligible to r...
Eligibility Criteria
Inclusion
- Subjects 20 years old and over;
- Sign of informed consent form;
- Patients with one missing tooth with D2, D3 bone density;
- Gums environment defined as alveolar bone height of 10 mm and above, bone width 8 mm and above;
- Have only one missing maxillary or mandibular posterior tooth (No. 4, 5, 6 or 7) who require a GBR prior to a dental implant.
- Bone defect(s) must be present with at least two walls missing.
- The opposing dentition must be nature teeth or fixed crowns or bridges on natural teeth or implants. Removable prostheses or dentures opposing the study implants are not allowed;
- Subject is able to understand and comply with protocol requirements, instructions and protocol stated restrictions
Exclusion
- Patients who have inadequate organ function described as below:
- ANC \< 1.5 x 109/L
- Platelets \< 100 x 109/L
- Hb \< 9 g/dL
- Serum bilirubin \< 1.5 x the upper limit of normal (ULN)
- Aspartate aminotransferase (AST \[SGOT\]) \< 2.5 × the ULN
- Alanine aminotransferase (ALT \[SGPT\]) \> 2.5 × the ULN
- Serum creatinine \> 1.5 mg/dL or a measured creatinine clearance \< 60 mL/min;
- History of neoplastic disease and had been treated with chemotherapy;
- Uncontrolled Diabetes Mellitus;
- Dialysis patients;
- Patients with cardiovascular disease;
- Osteoporosis patients and patients taking bisphosphonates;
- History of radiation therapy to the head and neck;
- Patients with temporomandibular disorder;
- Pregnant or nursing women;
- Presence of conditions requiring chronic routine prophylactic use of antibiotics (history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements);
- Medical conditions requiring prolonged use of steroids;
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene;
- Use of any investigational drug or device within the 30-day period immediately prior to implant surgery on study day 0;
- Alcoholism or drug abuse;
- Patients infected with HIV;
- Current smokers, ;
- Local inflammation, including untreated periodontitis;
- Mucosal diseases such as erosive lichen planus;
- History of local radiation therapy;
- Presence of osseous lesions;
- Unhealed extraction sites;
- Persistent intraoral infection;
- Patients with inadequate oral hygiene or unmotivated for adequate home care;
- Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.
- Patient with a pathology present near the site of dental implantation.
Key Trial Info
Start Date :
August 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 25 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04451486
Start Date
August 10 2018
End Date
April 25 2021
Last Update
June 30 2020
Active Locations (1)
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1
Taipei Medical University Hospital
Taipei, Taiwan, 110